Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy
Study Details
Study Description
Brief Summary
Patients will be switched from their current medication for painful diabetic peripheral neuropathy to evaluate the safety and efficacy of pregabalin as compared to placebo. All patients will receive pregabalin, and half of patients will receive placebo at some point during the study.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: pregabalin (Lyrica)
|
Drug: pregabalin (Lyrica)
Lyrica 150-300 mg/day. Medication is supplied as capsules and given 3 times daily.
|
Placebo Comparator: Placebo
|
Drug: Placebo
Placebo is supplied as capsules and given 3 times daily.
|
Outcome Measures
Primary Outcome Measures
- Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase [SB Baseline, Week 19 (DB Phase)]
Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.
Secondary Outcome Measures
- Time to Loss of Pain Response (Double-Blind Phase) [SB Baseline up to Week 19]
Time to loss of pain response (based on the daily pain diary data) during the DB treatment phase was analyzed using survival analysis technique. Loss of pain response was defined as less than (<) 15% pain response relative to the SB baseline. SB baseline refers to the last 7 pain diary entries up to and including Day 1.
- Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind Phase [SB Baseline, Week 6 (SB Phase)]
Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.
- Weekly Mean Pain Scores (Single-Blind Phase) [Week 1, 2, 3, 4, 5, 6]
Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain.
- Weekly Mean Pain Scores (Double-Blind Phase) [DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19]
Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1. DB baseline refers to the last 7 pain diary entries up to and including DB Day 1.
- Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Single-Blind Phase) [Week 6]
Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 6 is reported. SB baseline refers to the last 7 pain diary entries up to and including Day 1.
- Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase) [Week 19]
Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 19 is reported.
- Patient Global Impression of Change (PGIC) (Single-Blind Phase) [Week 6]
PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.
- Patient Global Impression of Change (PGIC) (Double-Blind Phase) [Week 19]
PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.
- Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase) [SB Baseline, Week 6]
Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment.
- Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase) [Week 19]
Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment.
- Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Single-Blind Phase) [SB Baseline, Week 6]
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no.
- Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Double-Blind Phase) [Week 19]
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no.
- Weekly Mean Sleep Interference Score (Single-Blind Phase) [SB Baseline, Week 1, 2, 3, 4, 5, 6]
Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). SB baseline refers to the last 7 pain diary entries up to and including Day 1.
- Weekly Mean Sleep Interference Score (Double-Blind Phase) [DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19]
Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain).
- Endpoint Mean Sleep Interference Score (Single-Blind Phase) [Week 6]
Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving SB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain).
- Endpoint Mean Sleep Interference Score (Double-Blind Phase) [Week 19]
Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving DB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain).
- Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase) [SB Baseline, Week 6]
QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL.
- Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase) [Week 19]
QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL.
- Pain Visual Analog Scale (VAS) (Single-Blind Phase) [SB Baseline, Week 6]
Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain.
- Pain Visual Analog Scale (VAS) (Double-Blind Phase) [Week 19]
Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain.
- Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase) [SB Baseline, Week 6]
BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes).
- Brief Pain Inventory-Short Form (BPI-sf) (Double-Blind Phase) [Week 19]
BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes).
- Hospital Anxiety and Depression Scale (HADS) (Single-Blind Phase) [SB Baseline, Week 6]
HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression.
- Hospital Anxiety and Depression Scale (HADS) (Double-Blind Phase) [Week 19]
HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression.
- Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase) [Week 6]
GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered "how would you rate the study medication you received for pain?" on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported.
- Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase) [Week 19]
GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered "how would you rate the study medication you received for pain?" on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients must have painful diabetic peripheral neuropathy and be receiving treatment for this condition.
Exclusion Criteria:
- Patients with other pain conditions cannot participate.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Greystone Medical Research, LLC | Birmingham | Alabama | United States | 35242 |
2 | Neurology Clinic, PC | Northport | Alabama | United States | 35476 |
3 | Horizon Clinical Research Associates, PLLC | Gilbert | Arizona | United States | 85295 |
4 | Dedicated Clinical Research, Inc. | Goodyear | Arizona | United States | 85395 |
5 | Dedicated Clinical Research | Goodyear | Arizona | United States | 85395 |
6 | Novara Clinical Research | Mesa | Arizona | United States | 85206 |
7 | Arizona Research Center | Phoenix | Arizona | United States | 85023 |
8 | Radiant Research, Inc. | Scottsdale | Arizona | United States | 85251 |
9 | Genova Clinical Research, Inc. | Tucson | Arizona | United States | 85704 |
10 | Central Arkansas Research | Hot Springs | Arkansas | United States | 71913 |
11 | Little Rock Diagnostic Clinic | Little Rock | Arkansas | United States | 72205 |
12 | Convergys Clinical Research, Inc. | Anaheim | California | United States | 92805 |
13 | Providence Clinical Research | Burbank | California | United States | 91505 |
14 | Valley Research | Fresno | California | United States | 93720 |
15 | Center for United Research, Inc. | Lakewood | California | United States | 90712 |
16 | Healthcare Partners Medical Group | Los Angeles | California | United States | 90015 |
17 | University of Southern California, Keck School of Medicine, Department of Neurology | Los Angeles | California | United States | 90033 |
18 | Richard S. Cherlin, MD | Los Gatos | California | United States | 95032 |
19 | Northridge Neurological Research | Northridge | California | United States | 91325 |
20 | Remek Research | Pomona | California | United States | 91767 |
21 | Sierra Clinical Research | Roseville | California | United States | 95661 |
22 | CNRI-San Diego, LLC | San Diego | California | United States | 92102 |
23 | San Diego Clinical Trials | San Diego | California | United States | 92120 |
24 | Center for Clinical Research, Inc. | San Francisco | California | United States | 94115 |
25 | Apex Research Institute | Santa Ana | California | United States | 92705 |
26 | Neurological Research Institute | Santa Monica | California | United States | 90404 |
27 | Diablo Clinical Research, Inc. | Walnut Creek | California | United States | 94598 |
28 | Foothills Pain Management | West Covina | California | United States | 91790 |
29 | Aurora Family Medicine Center, PC | Aurora | Colorado | United States | 80012 |
30 | Alpine Clinical Research Center, Inc. | Boulder | Colorado | United States | 80304 |
31 | Mountain View Clinical Research | Denver | Colorado | United States | 80209 |
32 | Chase Medical Research, LLC | Waterbury | Connecticut | United States | 06708 |
33 | Metabolic Research Institute, Inc. | Boynton Beach | Florida | United States | 33472 |
34 | Bradenton Research Center | Bradenton | Florida | United States | 34205 |
35 | Meridien Research | Bradenton | Florida | United States | 34208 |
36 | Meridien Research | Brooksville | Florida | United States | 34601 |
37 | Innovative Research of West Florida, Inc. | Clearwater | Florida | United States | 33756 |
38 | Clinical Research of West Florida, Inc. | Clearwater | Florida | United States | 33765 |
39 | Deerfield Beach Cardiology Research | Deerfield Beach | Florida | United States | 33442 |
40 | Gulfcoast Clinical Research Center | Fort Myers | Florida | United States | 33912 |
41 | MD Clinical | Hallandale Beach | Florida | United States | 33009 |
42 | Elite Research Institute | Miami | Florida | United States | 33169 |
43 | Suncoast Clinical Research, Inc. | New Port Richey | Florida | United States | 34652 |
44 | Laszlo J. Mate, MD | North Palm Beach | Florida | United States | 33408 |
45 | Family Care Specialists, Inc. | Ocala | Florida | United States | 34471 |
46 | Renstar Medical Research | Ocala | Florida | United States | 34471 |
47 | Compass Research, LLC | Orlando | Florida | United States | 32806 |
48 | Palm Beach Neurological Center, Advanced Research Consultants, Inc. | Palm Beach Gardens | Florida | United States | 33418 |
49 | Suncoast Clinical Research | Palm Harbor | Florida | United States | 34684 |
50 | Meridien Research | Saint Petersburg | Florida | United States | 33709 |
51 | Neurology Clinical Research, Inc. | Sunrise | Florida | United States | 33351 |
52 | Clinical Research of West Florida, Inc. | Tampa | Florida | United States | 33603 |
53 | Meridien Research | Tampa | Florida | United States | 33606 |
54 | Clinical Research of Central Florida | Winter Haven | Florida | United States | 33880 |
55 | NeuroTrials Research, Incorporated | Atlanta | Georgia | United States | 30342 |
56 | CPM Research Institute | Austell | Georgia | United States | 30106 |
57 | Columbus Research Foundation | Columbus | Georgia | United States | 31904 |
58 | Rockdale Medical Research Associates | Conyers | Georgia | United States | 30094 |
59 | Prism Research Group | Rome | Georgia | United States | 30165 |
60 | Valley Health Care | Rome | Georgia | United States | 30165 |
61 | East-West Medical Research Institute | Honolulu | Hawaii | United States | 96814 |
62 | Advanced Clinical Research | Meridian | Idaho | United States | 83642 |
63 | AMR Sakeena Research | Aurora | Illinois | United States | 60504 |
64 | Chicago Research Center, Inc. | Chicago | Illinois | United States | 60634 |
65 | American Medical Research, Inc. | Oak Brook | Illinois | United States | 60523 |
66 | MediSphere Medical Research Center, LLC | Evansville | Indiana | United States | 47714 |
67 | American Health Network | Greenfield | Indiana | United States | 46140 |
68 | Rehabilitation Associates of Indiana | Indianapolis | Indiana | United States | 46250 |
69 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160 |
70 | Heartland Research Associates, LLC | Wichita | Kansas | United States | 67207 |
71 | Kentucky Medical Research Center | Lexington | Kentucky | United States | 40504 |
72 | Endocrinology Center of Southwest Louisiana | Lake Charles | Louisiana | United States | 70601 |
73 | Heartland Research, LLC | Lake Charles | Louisiana | United States | 70601 |
74 | Primary Physician Care, LLC | Lake Charles | Louisiana | United States | 70601 |
75 | Arthritis and Diabetes Clinic, Inc | Monroe | Louisiana | United States | 71203 |
76 | Miray Medical Center | Brockton | Massachusetts | United States | 02301 |
77 | Clinical Research Center of Cape Cod, Inc. | Hyannis | Massachusetts | United States | 02601 |
78 | MedVadis Research Corporation | Watertown | Massachusetts | United States | 02472 |
79 | Clinical Pharmacology Study Group | Worcester | Massachusetts | United States | 01605 |
80 | Michigan Head Pain and Neurological Institute | Ann Arbor | Michigan | United States | 48104 |
81 | Harris and Associates MD, PC | Detroit | Michigan | United States | 48235 |
82 | Borgess Diabetes Center | Kalamazoo | Michigan | United States | 49048 |
83 | Borgess Research Institute | Kalamazoo | Michigan | United States | 49048 |
84 | William Beaumont Hospital | Royal Oak | Michigan | United States | 48073 |
85 | KMED Research | Saint Clair Shores | Michigan | United States | 48081 |
86 | William Beaumont Hospital | Troy | Michigan | United States | 48085 |
87 | Troy Internal Medicine, PC | Troy | Michigan | United States | 48098 |
88 | MAPS Applied Research Center, Inc. | Edina | Minnesota | United States | 55435 |
89 | Medical Advanced Pain Specialists (MAPS) | Edina | Minnesota | United States | 55435 |
90 | Medical Advanced Pain Specialists | Maple Grove | Minnesota | United States | 55369 |
91 | Medical Advanced Pain Specialists | Shakopee | Minnesota | United States | 55379 |
92 | CRC of Jackson | Jackson | Mississippi | United States | 39202 |
93 | Physician's Surgery Center | Jackson | Mississippi | United States | 39202 |
94 | Randall T. Huling, Jr., MD, CPI | Olive Branch | Mississippi | United States | 38654 |
95 | University of Missouri Healthcare/Cosmopolitan Diabetes and Endocrinology Center | Columbia | Missouri | United States | 65212 |
96 | Melinda A. Crockett-Maples | Marionville | Missouri | United States | 65705 |
97 | A & A Pain Institute of Saint Louis | Saint Louis | Missouri | United States | 63141 |
98 | Mercy Health Research | Saint Louis | Missouri | United States | 63141 |
99 | Clinvest | Springfield | Missouri | United States | 65807 |
100 | Lincoln Internal Medicine Associates | Lincoln | Nebraska | United States | 68516 |
101 | Desert Endocrinology Clinical Research Center | Henderson | Nevada | United States | 89052 |
102 | Desert Endocrinology | Las Vegas | Nevada | United States | 89117 |
103 | Office of Dr. Danka Michaels, MD | Las Vegas | Nevada | United States | 89128 |
104 | Office of Stephen Miller, M.D. | Las Vegas | Nevada | United States | 89144 |
105 | Raleigh Neurology Associates, P.A. | Raleigh | North Carolina | United States | 27607-6520 |
106 | Carolina Pharmaceutical Research | Statesville | North Carolina | United States | 28625 |
107 | Radiant Research, Inc. | Akron | Ohio | United States | 44311 |
108 | Community Research | Cincinnati | Ohio | United States | 45245 |
109 | Radiant Research | Cincinnati | Ohio | United States | 45249 |
110 | Hometown Urgent Care and Research | Dayton | Ohio | United States | 45432 |
111 | Providence Health Partners - Center for Clinical Research | Dayton | Ohio | United States | 45439 |
112 | Sooner Clinical Research | Oklahoma City | Oklahoma | United States | 73112 |
113 | Veronique Sebastian, MD | Oklahoma City | Oklahoma | United States | 73120 |
114 | Angelique Barreto, MD | Oklahoma City | Oklahoma | United States | 73134 |
115 | Oregon Health & Science University | Portland | Oregon | United States | 97239-3098 |
116 | Blair Orthopedic Associates, Inc. | Altoona | Pennsylvania | United States | 16602 |
117 | Altoona Center for Clinical Research | Duncansville | Pennsylvania | United States | 16635 |
118 | Research Protocol Management Specialists | Pittsburgh | Pennsylvania | United States | 15243 |
119 | Coastal Medical | East Greenwich | Rhode Island | United States | 02818 |
120 | Memorial Hospital of Rhode Island | Pawtucket | Rhode Island | United States | 02860 |
121 | Omega Medical Research | Warwick | Rhode Island | United States | 02886 |
122 | Aiken Center for Clinical Research | Aiken | South Carolina | United States | 29801 |
123 | TLM Medical Services, LLC | Columbia | South Carolina | United States | 29204 |
124 | Radiant Research Inc. | Greer | South Carolina | United States | 29651 |
125 | Neurology and Pain Clinic, LLC | Orangeburg | South Carolina | United States | 29118 |
126 | University Diabetes & Endocrine Consultants | Chattanooga | Tennessee | United States | 37403 |
127 | SCRI Research Center | Germantown | Tennessee | United States | 38138 |
128 | Sarah Cannon Research Institute | Jackson | Tennessee | United States | 38305 |
129 | AM Diabetes & Endocrinology Center | Memphis | Tennessee | United States | 38133 |
130 | Memphis Internal Medicine | Memphis | Tennessee | United States | 38138 |
131 | ClinRx Research LLC | Carrollton | Texas | United States | 75007 |
132 | Baylor University Medical Center | Dallas | Texas | United States | 75246 |
133 | University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | United States | 75390-8858 |
134 | Medical Group of Texas | Fort Worth | Texas | United States | 76104 |
135 | The Nerve and Muscle Center of Texas | Houston | Texas | United States | 77030 |
136 | ClinRx Research, LLC | Richardson | Texas | United States | 75080 |
137 | Paragon Research Center, LLC | San Antonio | Texas | United States | 78205 |
138 | Alamo Clinical Research | San Antonio | Texas | United States | 78212 |
139 | Cetero Research - San Antonio | San Antonio | Texas | United States | 78229 |
140 | Pioneer Research Solutions, Inc | Sugar Land | Texas | United States | 77479 |
141 | L. Craig Larsen and Clark C. Larsen | Murray | Utah | United States | 84107 |
142 | Aspen Clinical Research | Orem | Utah | United States | 84058 |
143 | Daniel B. Vine, MD | Salt Lake City | Utah | United States | 84107 |
144 | Wasatch Clinical Research | Salt Lake City | Utah | United States | 84107 |
145 | Jean Brown Research | Salt Lake City | Utah | United States | 84124 |
146 | Foot and Ankle Clinic | West Jordan | Utah | United States | 84088 |
147 | Neurological Associates, Incorporated | Henrico | Virginia | United States | 23226 |
148 | National Clinical Research - Norfolk, Inc. | Norfolk | Virginia | United States | 23502 |
149 | Spokane Internal Medicine | Spokane | Washington | United States | 99216 |
150 | Aurora Advanced Healthcare, Inc. | Milwaukee | Wisconsin | United States | 53209 |
151 | University of Calgary | Calgary | Alberta | Canada | T2N4Z6 |
152 | Winnipeg Health Sciences Centre | Winnipeg | Manitoba | Canada | R3A 1R9 |
153 | Winnipeg Regional Health Authority Sciences Centre Winnipeg | Winnipeg | Manitoba | Canada | R3E 3P4 |
154 | Capital District Health Authority, QEII Health Sciences Centre | Halifax | Nova Scotia | Canada | B3H 1V7 |
155 | Capital District Health Authority, QEII Health Sciences Centre | Halifax | Nova Scotia | Canada | B3H 2Y9 |
156 | The Ottawa Hospital, Riverside Campus - Riverside Professional Building | Ottawa | Ontario | Canada | K1H 1A2 |
157 | Toronto General Hospital | Toronto | Ontario | Canada | M5G 2C4 |
158 | Ponce School of Medicine & Health Sciences | Ponce | Puerto Rico | 00716 | |
159 | Instituto de Endocrinologia Diabetes y Metabolismo | Toa Baja | Puerto Rico | 00949 | |
160 | Bloemfontein Medi-Clinic | Bloemfontein | FREE State | South Africa | 9301 |
161 | Dr Makan's Rooms | Johannesburg | Gauteng | South Africa | 1827 |
162 | Chris Hani Baragwanath Hospital | Soweto | Gauteng | South Africa | 2013 |
163 | Randles Road Medical Centre | Durban | Kwa-zulu Natal | South Africa | 4000 |
164 | Chelmsford Medical Centre | Durban | Kwazulu Natal | South Africa | 4001 |
165 | Centre for Diabetes and Endocrinology | Durban | Kwazulu Natal | South Africa | 4091 |
166 | Parklands Medical Centre | Overport | Kwazulu Natal | South Africa | 4091 |
167 | Dr Jeevren Reddy's Surgery | Stanger | Kwazulu Natal | South Africa | 4450 |
168 | Dot Shuttleworth Centre for Diabetes | Durban | Overport | South Africa | 4091 |
169 | Centre for Diabetes and Endocrinology | Houghton, Johannesburg | South Africa | 2198 | |
170 | 102 Parklands Medical Centre | Overport, Durban | South Africa | 4001 | |
171 | Dr's Sauermann and Meyer | Polokwane | South Africa | ||
172 | Diabetes Care Centre | Pretoria | South Africa | 0001 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A0081242
- 2009-017389-21
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Pregabalin SB | Pregabalin DB | Placebo |
---|---|---|---|
Arm/Group Description | Participants who were inadequately controlled on their current diabetic peripheral neuropathy (DPN) treatment were switched to single-blind (SB) pregabalin capsules at a starting dose of 150 milligram per day (mg/day) and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced greater than or equal to (>=) 30 percent (%) pain reduction from baseline to Week 6 were eligible for double-blind (DB) treatment phase. | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase. | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase. |
Period Title: Single-Blind Phase (Up to Week 6) | |||
STARTED | 665 | 0 | 0 |
COMPLETED | 566 | 0 | 0 |
NOT COMPLETED | 99 | 0 | 0 |
Period Title: Single-Blind Phase (Up to Week 6) | |||
STARTED | 566 | 0 | 0 |
COMPLETED | 296 | 0 | 0 |
NOT COMPLETED | 270 | 0 | 0 |
Period Title: Single-Blind Phase (Up to Week 6) | |||
STARTED | 0 | 147 | 149 |
Treated | 0 | 147 | 147 |
COMPLETED | 0 | 125 | 113 |
NOT COMPLETED | 0 | 22 | 36 |
Baseline Characteristics
Arm/Group Title | Pregabalin SB |
---|---|
Arm/Group Description | Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase. |
Overall Participants | 665 |
Age, Customized (participants) [Number] | |
18 to 44 Years |
58
8.7%
|
45 to 64 Years |
417
62.7%
|
>=65 Years |
190
28.6%
|
Sex: Female, Male (Count of Participants) | |
Female |
302
45.4%
|
Male |
363
54.6%
|
Outcome Measures
Title | Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase |
---|---|
Description | Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1. |
Time Frame | SB Baseline, Week 19 (DB Phase) |
Outcome Measure Data
Analysis Population Description |
---|
Full analysis set (FAS) included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using Last Observation Carried Forward (LOCF). |
Arm/Group Title | Pregabalin DB | Placebo |
---|---|---|
Arm/Group Description | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase. | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase. |
Measure Participants | 147 | 147 |
Single-Blind Baseline |
6.8
(1.24)
|
6.7
(1.32)
|
Change at Week 19 (DB Phase) |
-3.9
(1.92)
|
-3.5
(2.10)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Pregabalin DB, Placebo |
---|---|---|
Comments | P-value was calculated using analysis of covariance (ANCOVA), with terms for baseline mean pain score, center and treatment in the model. | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.1221 |
Comments | ||
Method | ANCOVA | |
Comments | ||
Method of Estimation | Estimation Parameter | Least Squares Mean Difference |
Estimated Value | -0.32 | |
Confidence Interval |
(2-Sided) 95% -0.74 to 0.09 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Time to Loss of Pain Response (Double-Blind Phase) |
---|---|
Description | Time to loss of pain response (based on the daily pain diary data) during the DB treatment phase was analyzed using survival analysis technique. Loss of pain response was defined as less than (<) 15% pain response relative to the SB baseline. SB baseline refers to the last 7 pain diary entries up to and including Day 1. |
Time Frame | SB Baseline up to Week 19 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. |
Arm/Group Title | Pregabalin DB | Placebo |
---|---|---|
Arm/Group Description | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase. | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase. |
Measure Participants | 147 | 147 |
Median (95% Confidence Interval) [days] |
NA
|
NA
|
Title | Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind Phase |
---|---|
Description | Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1. |
Time Frame | SB Baseline, Week 6 (SB Phase) |
Outcome Measure Data
Analysis Population Description |
---|
Single-Blind Analysis Set (SBAS) included all participants who were enrolled in single-blind treatment phase and received at least 1 dose of study treatment. "N" (number of participants analyzed): participants who were evaluable for this measure and "n": participants who were evaluable for specified time-point. Missing data were imputed using LOCF. |
Arm/Group Title | Pregabalin SB |
---|---|
Arm/Group Description | Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase. |
Measure Participants | 663 |
SB Baseline (n= 663) |
6.7
(1.27)
|
Change at Week 6 (SB Phase) (n= 658) |
-2.2
(2.03)
|
Title | Weekly Mean Pain Scores (Single-Blind Phase) |
---|---|
Description | Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. |
Time Frame | Week 1, 2, 3, 4, 5, 6 |
Outcome Measure Data
Analysis Population Description |
---|
SBAS included all participants who were enrolled in single-blind treatment phase and received at least one dose of study treatment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure and "n" signifies participants who were evaluable for specified time-point. |
Arm/Group Title | Pregabalin SB |
---|---|
Arm/Group Description | Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase. |
Measure Participants | 657 |
Week 1 (n= 657) |
6.0
(1.62)
|
Week 2 (n= 636) |
5.4
(1.82)
|
Week 3 (n= 613) |
4.9
(1.93)
|
Week 4 (n= 585) |
4.6
(1.93)
|
Week 5 (n= 565) |
4.5
(1.92)
|
Week 6 (n= 548) |
4.3
(2.02)
|
Title | Weekly Mean Pain Scores (Double-Blind Phase) |
---|---|
Description | Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1. DB baseline refers to the last 7 pain diary entries up to and including DB Day 1. |
Time Frame | DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here "n" signifies participants who were evaluable for specified time-point for each arm group, respectively. |
Arm/Group Title | Pregabalin DB | Placebo |
---|---|---|
Arm/Group Description | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase. | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase. |
Measure Participants | 147 | 147 |
DB Baseline (n= 147, 147) |
3.1
(1.42)
|
3.0
(1.40)
|
Week 7 (n= 144, 145) |
3.2
(1.60)
|
3.3
(1.80)
|
Week 8 (n= 143, 142) |
3.2
(1.72)
|
3.6
(1.79)
|
Week 9 (n= 140, 133) |
3.0
(1.65)
|
3.4
(1.76)
|
Week 10 (n= 138, 133) |
3.0
(1.70)
|
3.4
(1.77)
|
Week 11 (n= 138, 128) |
2.9
(1.64)
|
3.3
(1.63)
|
Week 12 (n= 135, 123) |
2.9
(1.68)
|
3.2
(1.70)
|
Week 13 (n= 134, 122) |
2.9
(1.68)
|
3.1
(1.69)
|
Week 14 (n= 133, 122) |
2.9
(1.64)
|
3.1
(1.70)
|
Week 15 (n= 131, 118) |
2.9
(1.63)
|
3.0
(1.64)
|
Week 16 (n= 132, 118) |
2.8
(1.65)
|
3.0
(1.58)
|
Week 17 (n= 128, 115) |
2.7
(1.61)
|
2.9
(1.70)
|
Week 18 (n= 128, 115) |
2.8
(1.66)
|
2.9
(1.73)
|
Week 19 (n= 115, 104) |
2.7
(1.57)
|
2.8
(1.71)
|
Title | Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Single-Blind Phase) |
---|---|
Description | Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 6 is reported. SB baseline refers to the last 7 pain diary entries up to and including Day 1. |
Time Frame | Week 6 |
Outcome Measure Data
Analysis Population Description |
---|
SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Missing data were imputed using LOCF. |
Arm/Group Title | Pregabalin SB |
---|---|
Arm/Group Description | Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase. |
Measure Participants | 665 |
>=30 % Reduction |
49.92
7.5%
|
>=50 % Reduction |
27.22
4.1%
|
Title | Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase) |
---|---|
Description | Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 19 is reported. |
Time Frame | Week 19 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. |
Arm/Group Title | Pregabalin DB | Placebo |
---|---|---|
Arm/Group Description | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase. | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase. |
Measure Participants | 147 | 147 |
>=30% Reduction |
82.99
12.5%
|
79.19
NaN
|
>=50% Reduction |
62.59
9.4%
|
55.03
NaN
|
Title | Patient Global Impression of Change (PGIC) (Single-Blind Phase) |
---|---|
Description | PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported. |
Time Frame | Week 6 |
Outcome Measure Data
Analysis Population Description |
---|
SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study treatment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure. |
Arm/Group Title | Pregabalin SB |
---|---|
Arm/Group Description | Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase. |
Measure Participants | 620 |
Very Much Improved |
93
14%
|
Much Improved |
221
33.2%
|
Minimally Improved |
194
29.2%
|
No Change |
65
9.8%
|
Minimally Worse |
29
4.4%
|
Much Worse |
15
2.3%
|
Very Much Worse |
3
0.5%
|
Title | Patient Global Impression of Change (PGIC) (Double-Blind Phase) |
---|---|
Description | PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported. |
Time Frame | Week 19 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure. |
Arm/Group Title | Pregabalin DB | Placebo |
---|---|---|
Arm/Group Description | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase. | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase. |
Measure Participants | 138 | 134 |
Very Much Improved |
23
3.5%
|
23
NaN
|
Much Improved |
50
7.5%
|
46
NaN
|
Minimally Improved |
27
4.1%
|
28
NaN
|
No Change |
28
4.2%
|
20
NaN
|
Minimally Worse |
9
1.4%
|
6
NaN
|
Much Worse |
1
0.2%
|
8
NaN
|
Very Much Worse |
0
0%
|
3
NaN
|
Title | Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase) |
---|---|
Description | Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment. |
Time Frame | SB Baseline, Week 6 |
Outcome Measure Data
Analysis Population Description |
---|
SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study medication. Here "n" signifies participants who were evaluable for specified time-point. |
Arm/Group Title | Pregabalin SB |
---|---|
Arm/Group Description | Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase. |
Measure Participants | 665 |
SB Baseline: Sleep disturbance (n= 665) |
53.6
(24.00)
|
SB Baseline: Snoring (n= 664) |
44.7
(34.73)
|
SB Baseline: Awaken SOB or With Headache (n=665) |
18.9
(24.18)
|
SB Baseline: Quantity of sleep (n=663) |
5.9
(1.40)
|
SB Baseline: Sleep Adequacy (n=665) |
39.2
(23.22)
|
SB Baseline: Somnolence (n=665) |
42.6
(23.49)
|
SB Baseline: Sleep Problems Index (n=665) |
49.2
(18.17)
|
Week 6: Sleep disturbance (n= 621) |
33.6
(24.31)
|
Week 6: Snoring (n= 621) |
39.9
(34.83)
|
Week 6: Awaken SOB or With Headache (n= 621) |
12.6
(22.64)
|
Week 6: Quantity of sleep (n= 615) |
6.6
(1.64)
|
Week 6: Sleep Adequacy (n= 621) |
52.6
(25.55)
|
Week 6: Somnolence (n= 621) |
34.2
(24.11)
|
Week 6: Sleep Problems Index (n= 621) |
34.4
(18.82)
|
Title | Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase) |
---|---|
Description | Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment. |
Time Frame | Week 19 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure. |
Arm/Group Title | Pregabalin DB | Placebo |
---|---|---|
Arm/Group Description | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase. | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase. |
Measure Participants | 138 | 134 |
Sleep disturbance |
26.6
(21.69)
|
30.9
(23.05)
|
Snoring |
41.9
(36.24)
|
35.4
(35.95)
|
Awaken SOB or With Headache |
12.3
(23.72)
|
12.2
(23.89)
|
Quantity of sleep |
6.7
(1.34)
|
6.5
(1.47)
|
Sleep Adequacy |
59.2
(28.67)
|
59.0
(27.67)
|
Somnolence |
29.7
(24.39)
|
30.6
(22.98)
|
Sleep Problems Index |
28.5
(17.86)
|
30.9
(18.59)
|
Title | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Single-Blind Phase) |
---|---|
Description | MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. |
Time Frame | SB Baseline, Week 6 |
Outcome Measure Data
Analysis Population Description |
---|
SBAS included all participants who were enrolled into the single-blind treatment phase and received at least one dose of study medication. |
Arm/Group Title | Pregabalin SB |
---|---|
Arm/Group Description | Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase. |
Measure Participants | 665 |
SB Baseline |
180
27.1%
|
Week 6 |
266
40%
|
Title | Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Double-Blind Phase) |
---|---|
Description | MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. |
Time Frame | Week 19 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. |
Arm/Group Title | Pregabalin DB | Placebo |
---|---|---|
Arm/Group Description | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase. | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase. |
Measure Participants | 147 | 147 |
Number [participants] |
67
10.1%
|
60
NaN
|
Title | Weekly Mean Sleep Interference Score (Single-Blind Phase) |
---|---|
Description | Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). SB baseline refers to the last 7 pain diary entries up to and including Day 1. |
Time Frame | SB Baseline, Week 1, 2, 3, 4, 5, 6 |
Outcome Measure Data
Analysis Population Description |
---|
SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure and "n" signifies participants who were evaluable for specified time point. |
Arm/Group Title | Pregabalin SB |
---|---|
Arm/Group Description | Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase. |
Measure Participants | 663 |
SB Baseline (n= 663) |
5.9
(2.09)
|
Week 1 (n= 657) |
5.1
(2.22)
|
Week 2 (n= 636) |
4.5
(2.29)
|
Week 3 (n= 614) |
4.1
(2.30)
|
Week 4 (n= 589) |
3.8
(2.30)
|
Week 5 (n= 566) |
3.7
(2.29)
|
Week 6 (n= 548) |
3.6
(2.35)
|
Title | Weekly Mean Sleep Interference Score (Double-Blind Phase) |
---|---|
Description | Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). |
Time Frame | DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here "n" signifies participants who were evaluable for specified time-point for each arm group, respectively. |
Arm/Group Title | Pregabalin DB | Placebo |
---|---|---|
Arm/Group Description | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase. | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase. |
Measure Participants | 147 | 147 |
DB Baseline (n= 147, 147) |
2.5
(1.79)
|
2.3
(1.66)
|
Week 7 (n= 144, 145) |
2.6
(1.92)
|
2.7
(1.99)
|
Week 8 (n= 143, 142) |
2.6
(1.98)
|
3.0
(1.98)
|
Week 9 (n= 140, 134) |
2.3
(1.88)
|
2.7
(1.94)
|
Week 10 (n= 138, 133) |
2.3
(1.90)
|
2.7
(1.98)
|
Week 11 (n= 138, 128) |
2.2
(1.81)
|
2.5
(1.78)
|
Week 12 (n= 136, 123) |
2.3
(1.90)
|
2.4
(1.84)
|
Week 13 (n= 134, 122) |
2.3
(1.87)
|
2.3
(1.78)
|
Week 14 (n= 133, 122) |
2.3
(1.93)
|
2.3
(1.80)
|
Week 15 (n= 132, 120) |
2.4
(1.93)
|
2.3
(1.80)
|
Week 16 (n= 132, 120) |
2.3
(1.90)
|
2.3
(1.77)
|
Week 17 (n= 129, 116) |
2.2
(1.88)
|
2.2
(1.85)
|
Week 18 (n= 128, 116) |
2.3
(1.92)
|
2.3
(1.85)
|
Week 19 (n= 121, 111) |
2.3
(2.05)
|
2.2
(1.80)
|
Title | Endpoint Mean Sleep Interference Score (Single-Blind Phase) |
---|---|
Description | Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving SB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain). |
Time Frame | Week 6 |
Outcome Measure Data
Analysis Population Description |
---|
SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Missing data were imputed using LOCF. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure. |
Arm/Group Title | Pregabalin SB |
---|---|
Arm/Group Description | Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase. |
Measure Participants | 658 |
Mean (Standard Deviation) [units on a scale] |
3.8
(2.42)
|
Title | Endpoint Mean Sleep Interference Score (Double-Blind Phase) |
---|---|
Description | Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving DB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain). |
Time Frame | Week 19 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure. |
Arm/Group Title | Pregabalin DB | Placebo |
---|---|---|
Arm/Group Description | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase. | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase. |
Measure Participants | 138 | 132 |
Mean (Standard Deviation) [units on a scale] |
2.4
(2.10)
|
2.4
(2.05)
|
Title | Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase) |
---|---|
Description | QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL. |
Time Frame | SB Baseline, Week 6 |
Outcome Measure Data
Analysis Population Description |
---|
SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here "n" signifies participants who were evaluable for specified time point. |
Arm/Group Title | Pregabalin SB |
---|---|
Arm/Group Description | Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase. |
Measure Participants | 665 |
SB Baseline: Total QOL Scores (n= 665) |
42.6
(22.22)
|
SB Baseline: Ph Fn/Large Fiber (n= 665) |
23.9
(13.07)
|
SB Baseline: Activities of Daily Living (n= 665) |
3.2
(3.69)
|
SB Baseline: Symptoms (n= 665) |
10.8
(5.55)
|
SB Baseline: Small Fiber (n= 665) |
3.4
(3.40)
|
SB Baseline: Autonomic (n= 665) |
1.3
(1.74)
|
Week 6: Total QOL Scores (n= 618) |
29.3
(21.76)
|
Week 6: Ph Fn/Large Fiber (n= 618) |
15.8
(12.62)
|
Week 6: Activities of Daily Living (n= 618) |
2.2
(3.08)
|
Week 6: Symptoms (n= 618) |
7.8
(5.72)
|
Week 6: Small Fiber (n= 618) |
2.3
(2.99)
|
Week 6: Autonomic (n= 618) |
1.1
(1.69)
|
Title | Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase) |
---|---|
Description | QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL. |
Time Frame | Week 19 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure. |
Arm/Group Title | Pregabalin DB | Placebo |
---|---|---|
Arm/Group Description | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase. | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase. |
Measure Participants | 138 | 134 |
Total QOL Scores |
21.9
(20.02)
|
24.1
(21.06)
|
Ph Fn/Large Fiber |
11.4
(11.28)
|
12.9
(12.72)
|
Activities of Daily Living |
1.8
(2.85)
|
1.8
(2.79)
|
Symptoms |
6.1
(5.04)
|
6.6
(5.29)
|
Small Fiber |
1.8
(3.38)
|
1.7
(2.50)
|
Autonomic |
0.9
(1.55)
|
1.1
(1.53)
|
Title | Pain Visual Analog Scale (VAS) (Single-Blind Phase) |
---|---|
Description | Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain. |
Time Frame | SB Baseline, Week 6 |
Outcome Measure Data
Analysis Population Description |
---|
SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here "n" signifies participants who were evaluable for specified time-point. |
Arm/Group Title | Pregabalin SB |
---|---|
Arm/Group Description | Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase. |
Measure Participants | 665 |
SB Baseline (n= 665) |
68.1
(13.79)
|
Week 6 (n= 621) |
39.8
(23.19)
|
Title | Pain Visual Analog Scale (VAS) (Double-Blind Phase) |
---|---|
Description | Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain. |
Time Frame | Week 19 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure. |
Arm/Group Title | Pregabalin DB | Placebo |
---|---|---|
Arm/Group Description | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase. | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase. |
Measure Participants | 138 | 134 |
Mean (Standard Deviation) [mm] |
25.3
(20.98)
|
30.1
(23.44)
|
Title | Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase) |
---|---|
Description | BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes). |
Time Frame | SB Baseline, Week 6 |
Outcome Measure Data
Analysis Population Description |
---|
SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here "n" signifies participants who were evaluable for specified time-point. |
Arm/Group Title | Pregabalin SB |
---|---|
Arm/Group Description | Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase. |
Measure Participants | 665 |
SB Baseline: Pain Severity (n= 665) |
6.1
(1.45)
|
SB Baseline: Pain Interference (n= 665) |
5.2
(2.09)
|
Week 6: Pain Severity (n= 637) |
3.9
(2.13)
|
Week 6: Pain Interference (n= 637) |
3.1
(2.31)
|
Title | Brief Pain Inventory-Short Form (BPI-sf) (Double-Blind Phase) |
---|---|
Description | BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes). |
Time Frame | Week 19 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure. |
Arm/Group Title | Pregabalin DB | Placebo |
---|---|---|
Arm/Group Description | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase. | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase. |
Measure Participants | 140 | 136 |
Pain Severity |
2.6
(1.85)
|
3.0
(2.03)
|
Pain Interference |
2.0
(2.05)
|
2.4
(2.10)
|
Title | Hospital Anxiety and Depression Scale (HADS) (Single-Blind Phase) |
---|---|
Description | HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression. |
Time Frame | SB Baseline, Week 6 |
Outcome Measure Data
Analysis Population Description |
---|
SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here "N" (number of participants) signifies participants who were evaluable for this measure and "n" signifies participants who were evaluable for specified time point. |
Arm/Group Title | Pregabalin SB |
---|---|
Arm/Group Description | Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase. |
Measure Participants | 663 |
SB Baseline: HADS-A (n= 663) |
5.8
(3.95)
|
SB Baseline: HADS-D (n= 663) |
5.3
(3.70)
|
Week 6: HADS-A (n= 616) |
4.6
(3.54)
|
Week 6: HADS-D (n= 616) |
4.0
(3.52)
|
Title | Hospital Anxiety and Depression Scale (HADS) (Double-Blind Phase) |
---|---|
Description | HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression. |
Time Frame | Week 19 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Missing data were imputed using LOCF. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure. |
Arm/Group Title | Pregabalin DB | Placebo |
---|---|---|
Arm/Group Description | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase. | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase. |
Measure Participants | 138 | 134 |
HADS-A |
3.8
(2.94)
|
4.3
(3.56)
|
HADS-D |
3.3
(3.12)
|
3.5
(3.28)
|
Title | Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase) |
---|---|
Description | GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered "how would you rate the study medication you received for pain?" on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported. |
Time Frame | Week 6 |
Outcome Measure Data
Analysis Population Description |
---|
SBAS included all participants who were enrolled into the single-blind treatment phase and received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure. |
Arm/Group Title | Pregabalin SB |
---|---|
Arm/Group Description | Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase. |
Measure Participants | 621 |
Very Satisfied |
241
36.2%
|
Somewhat Satisfied |
181
27.2%
|
Slightly Satisfied |
66
9.9%
|
Neither Satisfied Nor Dissatisfied |
71
10.7%
|
Slightly Dissatisfied |
22
3.3%
|
Somewhat Dissatisfied |
21
3.2%
|
Very Dissatisfied |
19
2.9%
|
Title | Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase) |
---|---|
Description | GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered "how would you rate the study medication you received for pain?" on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported. |
Time Frame | Week 19 |
Outcome Measure Data
Analysis Population Description |
---|
FAS included all participants randomized to double-blind treatment who received at least 1 dose of double-blind study treatment. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure. |
Arm/Group Title | Pregabalin DB | Placebo |
---|---|---|
Arm/Group Description | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase. | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase. |
Measure Participants | 138 | 134 |
Very Satisfied |
80
12%
|
64
NaN
|
Somewhat Satisfied |
35
5.3%
|
36
NaN
|
Slightly Satisfied |
9
1.4%
|
14
NaN
|
Neither Satisfied Nor Dissatisfied |
6
0.9%
|
10
NaN
|
Slightly Dissatisfied |
5
0.8%
|
2
NaN
|
Somewhat Dissatisfied |
1
0.2%
|
6
NaN
|
Very Dissatisfied |
2
0.3%
|
2
NaN
|
Adverse Events
Time Frame | ||||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. | |||||
Arm/Group Title | Pregabalin SB | Pregabalin DB | Placebo | |||
Arm/Group Description | Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase. | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase. | Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase. | |||
All Cause Mortality |
||||||
Pregabalin SB | Pregabalin DB | Placebo | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
Pregabalin SB | Pregabalin DB | Placebo | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 17/665 (2.6%) | 11/147 (7.5%) | 6/149 (4%) | |||
Blood and lymphatic system disorders | ||||||
Anaemia | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Cardiac disorders | ||||||
Acute coronary syndrome | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Angina pectoris | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Atrial fibrillation | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Bradycardia | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Coronary artery disease | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Myocardial infarction | 0/665 (0%) | 2/147 (1.4%) | 0/149 (0%) | |||
Eye disorders | ||||||
Vitreous haemorrhage | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Gastrointestinal disorders | ||||||
Rectal haemorrhage | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
General disorders | ||||||
Chest pain | 1/665 (0.2%) | 1/147 (0.7%) | 0/149 (0%) | |||
Generalised oedema | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Non-cardiac chest pain | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Oedema | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Hepatobiliary disorders | ||||||
Cholelithiasis | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Infections and infestations | ||||||
Cellulitis | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Gangrene | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Osteomyelitis | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Pneumonia | 3/665 (0.5%) | 1/147 (0.7%) | 0/149 (0%) | |||
Sepsis | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Tracheitis | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Upper respiratory tract infection | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Urinary tract infection | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Urosepsis | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Injury, poisoning and procedural complications | ||||||
Burns first degree | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Femoral neck fracture | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Rib fracture | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Road traffic accident | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Soft tissue injury | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Investigations | ||||||
Blood pressure increased | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Metabolism and nutrition disorders | ||||||
Diabetes mellitus inadequate control | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Diabetic complication | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Hyperglycaemia | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Hypoglycaemia | 1/665 (0.2%) | 0/147 (0%) | 1/149 (0.7%) | |||
Ketoacidosis | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Musculoskeletal and connective tissue disorders | ||||||
Arthralgia | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Nervous system disorders | ||||||
Cerebrovascular accident | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Presyncope | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Transient ischaemic attack | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Psychiatric disorders | ||||||
Depression | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Respiratory, thoracic and mediastinal disorders | ||||||
Chronic obstructive pulmonary disease | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Dyspnoea | 0/665 (0%) | 1/147 (0.7%) | 1/149 (0.7%) | |||
Respiratory failure | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
Pregabalin SB | Pregabalin DB | Placebo | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 331/665 (49.8%) | 86/147 (58.5%) | 94/149 (63.1%) | |||
Blood and lymphatic system disorders | ||||||
Anaemia | 1/665 (0.2%) | 2/147 (1.4%) | 1/149 (0.7%) | |||
Eosinophilia | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Leukocytosis | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Cardiac disorders | ||||||
Arrhythmia | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Cardiac failure | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Coronary artery disease | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Extrasystoles | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Palpitations | 2/665 (0.3%) | 0/147 (0%) | 0/149 (0%) | |||
Ear and labyrinth disorders | ||||||
Tinnitus | 3/665 (0.5%) | 1/147 (0.7%) | 1/149 (0.7%) | |||
Vertigo | 5/665 (0.8%) | 0/147 (0%) | 2/149 (1.3%) | |||
Eye disorders | ||||||
Cataract | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Conjunctivitis | 3/665 (0.5%) | 1/147 (0.7%) | 0/149 (0%) | |||
Cystoid macular oedema | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Diplopia | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Dry eye | 2/665 (0.3%) | 0/147 (0%) | 0/149 (0%) | |||
Eye haemorrhage | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Eye pain | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Periorbital oedema | 1/665 (0.2%) | 1/147 (0.7%) | 0/149 (0%) | |||
Retinal haemorrhage | 2/665 (0.3%) | 1/147 (0.7%) | 1/149 (0.7%) | |||
Retinal oedema | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Retinopathy hypertensive | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Vision blurred | 12/665 (1.8%) | 0/147 (0%) | 1/149 (0.7%) | |||
Visual impairment | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Vitreous disorder | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Vitreous haemorrhage | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Gastrointestinal disorders | ||||||
Abdominal discomfort | 1/665 (0.2%) | 1/147 (0.7%) | 1/149 (0.7%) | |||
Abdominal distension | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Abdominal pain | 1/665 (0.2%) | 1/147 (0.7%) | 1/149 (0.7%) | |||
Abdominal pain upper | 1/665 (0.2%) | 0/147 (0%) | 1/149 (0.7%) | |||
Abdominal tenderness | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Constipation | 15/665 (2.3%) | 2/147 (1.4%) | 3/149 (2%) | |||
Dental caries | 1/665 (0.2%) | 0/147 (0%) | 1/149 (0.7%) | |||
Diarrhoea | 15/665 (2.3%) | 5/147 (3.4%) | 6/149 (4%) | |||
Dry mouth | 12/665 (1.8%) | 5/147 (3.4%) | 3/149 (2%) | |||
Dyspepsia | 2/665 (0.3%) | 0/147 (0%) | 0/149 (0%) | |||
Flatulence | 4/665 (0.6%) | 0/147 (0%) | 0/149 (0%) | |||
Frequent bowel movements | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Gastrooesophageal reflux disease | 2/665 (0.3%) | 2/147 (1.4%) | 0/149 (0%) | |||
Hypoaesthesia oral | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Impaired gastric emptying | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Irritable bowel syndrome | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Lip disorder | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Lip swelling | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Nausea | 22/665 (3.3%) | 4/147 (2.7%) | 5/149 (3.4%) | |||
Oesophageal spasm | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Toothache | 2/665 (0.3%) | 0/147 (0%) | 0/149 (0%) | |||
Vomiting | 5/665 (0.8%) | 2/147 (1.4%) | 4/149 (2.7%) | |||
General disorders | ||||||
Asthenia | 2/665 (0.3%) | 2/147 (1.4%) | 0/149 (0%) | |||
Breakthrough pain | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Chest pain | 4/665 (0.6%) | 1/147 (0.7%) | 0/149 (0%) | |||
Device breakage | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Face oedema | 1/665 (0.2%) | 1/147 (0.7%) | 0/149 (0%) | |||
Fatigue | 18/665 (2.7%) | 3/147 (2%) | 4/149 (2.7%) | |||
Feeling abnormal | 3/665 (0.5%) | 0/147 (0%) | 0/149 (0%) | |||
Feeling hot | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Feeling jittery | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Foaming at mouth | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Gait disturbance | 2/665 (0.3%) | 1/147 (0.7%) | 2/149 (1.3%) | |||
Generalised oedema | 2/665 (0.3%) | 1/147 (0.7%) | 1/149 (0.7%) | |||
Implant site pruritus | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Influenza like illness | 5/665 (0.8%) | 1/147 (0.7%) | 0/149 (0%) | |||
Irritability | 1/665 (0.2%) | 0/147 (0%) | 1/149 (0.7%) | |||
Local swelling | 1/665 (0.2%) | 0/147 (0%) | 1/149 (0.7%) | |||
Malaise | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Oedema | 10/665 (1.5%) | 6/147 (4.1%) | 5/149 (3.4%) | |||
Oedema peripheral | 53/665 (8%) | 20/147 (13.6%) | 16/149 (10.7%) | |||
Pain | 1/665 (0.2%) | 2/147 (1.4%) | 1/149 (0.7%) | |||
Pyrexia | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Thirst | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Immune system disorders | ||||||
Hypersensitivity | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Seasonal allergy | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Infections and infestations | ||||||
Acarodermatitis | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Acute sinusitis | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Body tinea | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Bronchitis | 3/665 (0.5%) | 3/147 (2%) | 0/149 (0%) | |||
Candidiasis | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Cellulitis | 5/665 (0.8%) | 4/147 (2.7%) | 0/149 (0%) | |||
Cystitis | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Ear infection | 2/665 (0.3%) | 0/147 (0%) | 1/149 (0.7%) | |||
Gastroenteritis | 1/665 (0.2%) | 1/147 (0.7%) | 0/149 (0%) | |||
Gastroenteritis viral | 3/665 (0.5%) | 1/147 (0.7%) | 1/149 (0.7%) | |||
Gastrointestinal viral infection | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Herpes zoster | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Hordeolum | 1/665 (0.2%) | 1/147 (0.7%) | 0/149 (0%) | |||
Influenza | 1/665 (0.2%) | 3/147 (2%) | 0/149 (0%) | |||
Localised infection | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Nasopharyngitis | 5/665 (0.8%) | 4/147 (2.7%) | 3/149 (2%) | |||
Oral herpes | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Pneumonia | 2/665 (0.3%) | 0/147 (0%) | 1/149 (0.7%) | |||
Postoperative wound infection | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Rhinitis | 1/665 (0.2%) | 1/147 (0.7%) | 0/149 (0%) | |||
Sinusitis | 4/665 (0.6%) | 2/147 (1.4%) | 3/149 (2%) | |||
Skin candida | 1/665 (0.2%) | 1/147 (0.7%) | 0/149 (0%) | |||
Staphylococcal infection | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Tinea pedis | 0/665 (0%) | 0/147 (0%) | 2/149 (1.3%) | |||
Tooth abscess | 2/665 (0.3%) | 0/147 (0%) | 0/149 (0%) | |||
Tooth infection | 3/665 (0.5%) | 0/147 (0%) | 1/149 (0.7%) | |||
Upper respiratory tract infection | 11/665 (1.7%) | 7/147 (4.8%) | 7/149 (4.7%) | |||
Urinary tract infection | 10/665 (1.5%) | 3/147 (2%) | 3/149 (2%) | |||
Viral upper respiratory tract infection | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Injury, poisoning and procedural complications | ||||||
Arthropod bite | 2/665 (0.3%) | 0/147 (0%) | 0/149 (0%) | |||
Burns second degree | 1/665 (0.2%) | 1/147 (0.7%) | 0/149 (0%) | |||
Contusion | 2/665 (0.3%) | 1/147 (0.7%) | 0/149 (0%) | |||
Ear canal injury | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Excoriation | 2/665 (0.3%) | 1/147 (0.7%) | 0/149 (0%) | |||
Fall | 3/665 (0.5%) | 1/147 (0.7%) | 1/149 (0.7%) | |||
Foot fracture | 2/665 (0.3%) | 0/147 (0%) | 1/149 (0.7%) | |||
Laceration | 3/665 (0.5%) | 0/147 (0%) | 0/149 (0%) | |||
Ligament sprain | 1/665 (0.2%) | 1/147 (0.7%) | 3/149 (2%) | |||
Limb injury | 1/665 (0.2%) | 1/147 (0.7%) | 0/149 (0%) | |||
Meniscus lesion | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Muscle strain | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Rib fracture | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Road traffic accident | 3/665 (0.5%) | 1/147 (0.7%) | 0/149 (0%) | |||
Skeletal injury | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Thermal burn | 2/665 (0.3%) | 0/147 (0%) | 0/149 (0%) | |||
Wound | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Investigations | ||||||
Blood amylase increased | 1/665 (0.2%) | 1/147 (0.7%) | 0/149 (0%) | |||
Blood creatine phosphokinase increased | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Blood creatinine increased | 0/665 (0%) | 2/147 (1.4%) | 2/149 (1.3%) | |||
Blood glucose increased | 0/665 (0%) | 1/147 (0.7%) | 1/149 (0.7%) | |||
Blood pressure diastolic abnormal | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Blood urea increased | 0/665 (0%) | 2/147 (1.4%) | 0/149 (0%) | |||
Blood uric acid increased | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Body temperature increased | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Breath sounds abnormal | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Cardiac murmur | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Haematocrit decreased | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Heart rate increased | 2/665 (0.3%) | 0/147 (0%) | 0/149 (0%) | |||
Hepatic enzyme increased | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Liver function test abnormal | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Platelet count decreased | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Urinary casts | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Urine analysis abnormal | 1/665 (0.2%) | 0/147 (0%) | 1/149 (0.7%) | |||
Weight increased | 11/665 (1.7%) | 6/147 (4.1%) | 3/149 (2%) | |||
Metabolism and nutrition disorders | ||||||
Dehydration | 1/665 (0.2%) | 1/147 (0.7%) | 0/149 (0%) | |||
Diabetes mellitus | 1/665 (0.2%) | 1/147 (0.7%) | 0/149 (0%) | |||
Diabetes mellitus inadequate control | 0/665 (0%) | 0/147 (0%) | 2/149 (1.3%) | |||
Fluid retention | 2/665 (0.3%) | 0/147 (0%) | 0/149 (0%) | |||
Gout | 1/665 (0.2%) | 0/147 (0%) | 1/149 (0.7%) | |||
Hyperglycaemia | 5/665 (0.8%) | 1/147 (0.7%) | 0/149 (0%) | |||
Hyperlipidaemia | 1/665 (0.2%) | 0/147 (0%) | 1/149 (0.7%) | |||
Hypoglycaemia | 2/665 (0.3%) | 1/147 (0.7%) | 0/149 (0%) | |||
Hypokalaemia | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Increased appetite | 5/665 (0.8%) | 0/147 (0%) | 2/149 (1.3%) | |||
Vitamin B12 deficiency | 1/665 (0.2%) | 1/147 (0.7%) | 0/149 (0%) | |||
Vitamin D deficiency | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Musculoskeletal and connective tissue disorders | ||||||
Arthralgia | 7/665 (1.1%) | 3/147 (2%) | 2/149 (1.3%) | |||
Arthropathy | 2/665 (0.3%) | 2/147 (1.4%) | 1/149 (0.7%) | |||
Back pain | 10/665 (1.5%) | 2/147 (1.4%) | 3/149 (2%) | |||
Exostosis | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Extremity contracture | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Joint stiffness | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Joint swelling | 1/665 (0.2%) | 2/147 (1.4%) | 0/149 (0%) | |||
Muscle spasms | 5/665 (0.8%) | 2/147 (1.4%) | 1/149 (0.7%) | |||
Muscle tightness | 2/665 (0.3%) | 1/147 (0.7%) | 0/149 (0%) | |||
Muscular weakness | 5/665 (0.8%) | 3/147 (2%) | 0/149 (0%) | |||
Musculoskeletal chest pain | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Musculoskeletal pain | 2/665 (0.3%) | 0/147 (0%) | 1/149 (0.7%) | |||
Musculoskeletal stiffness | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Myalgia | 3/665 (0.5%) | 0/147 (0%) | 1/149 (0.7%) | |||
Neck pain | 3/665 (0.5%) | 1/147 (0.7%) | 0/149 (0%) | |||
Osteoarthritis | 3/665 (0.5%) | 2/147 (1.4%) | 1/149 (0.7%) | |||
Pain in extremity | 19/665 (2.9%) | 3/147 (2%) | 8/149 (5.4%) | |||
Rhabdomyolysis | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Rotator cuff syndrome | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Spinal osteoarthritis | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Tendonitis | 1/665 (0.2%) | 0/147 (0%) | 1/149 (0.7%) | |||
Trigger finger | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Nervous system disorders | ||||||
Akathisia | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Allodynia | 3/665 (0.5%) | 2/147 (1.4%) | 2/149 (1.3%) | |||
Amnesia | 1/665 (0.2%) | 0/147 (0%) | 1/149 (0.7%) | |||
Areflexia | 2/665 (0.3%) | 0/147 (0%) | 1/149 (0.7%) | |||
Ataxia | 5/665 (0.8%) | 0/147 (0%) | 1/149 (0.7%) | |||
Balance disorder | 4/665 (0.6%) | 0/147 (0%) | 0/149 (0%) | |||
Burning sensation | 2/665 (0.3%) | 0/147 (0%) | 1/149 (0.7%) | |||
Carpal tunnel syndrome | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Cerebrovascular disorder | 1/665 (0.2%) | 0/147 (0%) | 1/149 (0.7%) | |||
Cognitive disorder | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Convulsion | 2/665 (0.3%) | 0/147 (0%) | 0/149 (0%) | |||
Coordination abnormal | 2/665 (0.3%) | 0/147 (0%) | 0/149 (0%) | |||
Decreased vibratory sense | 3/665 (0.5%) | 0/147 (0%) | 1/149 (0.7%) | |||
Depressed level of consciousness | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Diabetic neuropathy | 6/665 (0.9%) | 1/147 (0.7%) | 2/149 (1.3%) | |||
Disturbance in attention | 3/665 (0.5%) | 0/147 (0%) | 2/149 (1.3%) | |||
Dizziness | 45/665 (6.8%) | 4/147 (2.7%) | 2/149 (1.3%) | |||
Dizziness postural | 1/665 (0.2%) | 0/147 (0%) | 1/149 (0.7%) | |||
Dysgeusia | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Headache | 29/665 (4.4%) | 4/147 (2.7%) | 4/149 (2.7%) | |||
Hyperaesthesia | 3/665 (0.5%) | 2/147 (1.4%) | 4/149 (2.7%) | |||
Hypersomnia | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Hypoaesthesia | 7/665 (1.1%) | 1/147 (0.7%) | 2/149 (1.3%) | |||
Lethargy | 2/665 (0.3%) | 1/147 (0.7%) | 1/149 (0.7%) | |||
Memory impairment | 3/665 (0.5%) | 0/147 (0%) | 0/149 (0%) | |||
Migraine | 2/665 (0.3%) | 0/147 (0%) | 1/149 (0.7%) | |||
Neuralgia | 2/665 (0.3%) | 0/147 (0%) | 1/149 (0.7%) | |||
Neuropathy peripheral | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Paraesthesia | 3/665 (0.5%) | 1/147 (0.7%) | 1/149 (0.7%) | |||
Poor quality sleep | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Presyncope | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Sedation | 5/665 (0.8%) | 0/147 (0%) | 0/149 (0%) | |||
Sensory disturbance | 0/665 (0%) | 0/147 (0%) | 2/149 (1.3%) | |||
Sinus headache | 1/665 (0.2%) | 1/147 (0.7%) | 0/149 (0%) | |||
Somnolence | 38/665 (5.7%) | 6/147 (4.1%) | 5/149 (3.4%) | |||
Tension headache | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Tremor | 1/665 (0.2%) | 1/147 (0.7%) | 0/149 (0%) | |||
Psychiatric disorders | ||||||
Abnormal dreams | 1/665 (0.2%) | 0/147 (0%) | 1/149 (0.7%) | |||
Agitation | 2/665 (0.3%) | 0/147 (0%) | 0/149 (0%) | |||
Anorgasmia | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Anxiety | 3/665 (0.5%) | 0/147 (0%) | 0/149 (0%) | |||
Bradyphrenia | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Confusional state | 2/665 (0.3%) | 0/147 (0%) | 0/149 (0%) | |||
Depressed mood | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Depression | 6/665 (0.9%) | 2/147 (1.4%) | 2/149 (1.3%) | |||
Depressive symptom | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Disorientation | 2/665 (0.3%) | 0/147 (0%) | 0/149 (0%) | |||
Euphoric mood | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Hallucination, visual | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Insomnia | 11/665 (1.7%) | 0/147 (0%) | 2/149 (1.3%) | |||
Libido decreased | 1/665 (0.2%) | 0/147 (0%) | 1/149 (0.7%) | |||
Mood swings | 2/665 (0.3%) | 1/147 (0.7%) | 0/149 (0%) | |||
Nervousness | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Nightmare | 3/665 (0.5%) | 1/147 (0.7%) | 0/149 (0%) | |||
Post-traumatic stress disorder | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Sleep disorder | 1/665 (0.2%) | 0/147 (0%) | 1/149 (0.7%) | |||
Suicidal ideation | 2/665 (0.3%) | 0/147 (0%) | 0/149 (0%) | |||
Thinking abnormal | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Renal and urinary disorders | ||||||
Haematuria | 1/665 (0.2%) | 0/147 (0%) | 1/149 (0.7%) | |||
Nocturia | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Renal failure | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Renal failure acute | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Renal impairment | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Renal pain | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Urine odour abnormal | 1/665 (0.2%) | 1/147 (0.7%) | 0/149 (0%) | |||
Reproductive system and breast disorders | ||||||
Erectile dysfunction | 3/665 (0.5%) | 0/147 (0%) | 1/149 (0.7%) | |||
Respiratory, thoracic and mediastinal disorders | ||||||
Cough | 3/665 (0.5%) | 1/147 (0.7%) | 1/149 (0.7%) | |||
Dyspnoea | 4/665 (0.6%) | 1/147 (0.7%) | 2/149 (1.3%) | |||
Dyspnoea exertional | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Increased upper airway secretion | 1/665 (0.2%) | 1/147 (0.7%) | 0/149 (0%) | |||
Nasal congestion | 2/665 (0.3%) | 0/147 (0%) | 0/149 (0%) | |||
Oropharyngeal pain | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Painful respiration | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Pharyngeal oedema | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Productive cough | 1/665 (0.2%) | 0/147 (0%) | 1/149 (0.7%) | |||
Respiratory tract congestion | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Rhinitis allergic | 0/665 (0%) | 0/147 (0%) | 2/149 (1.3%) | |||
Sinus congestion | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Sleep apnoea syndrome | 0/665 (0%) | 2/147 (1.4%) | 0/149 (0%) | |||
Snoring | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Skin and subcutaneous tissue disorders | ||||||
Acne | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Alopecia | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Blister | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Decubitus ulcer | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Dermal cyst | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Dry skin | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Eczema | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Heat rash | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Hyperhidrosis | 4/665 (0.6%) | 1/147 (0.7%) | 0/149 (0%) | |||
Hyperkeratosis | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Nail hypertrophy | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Pruritus | 3/665 (0.5%) | 0/147 (0%) | 2/149 (1.3%) | |||
Pruritus generalised | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Rash | 4/665 (0.6%) | 1/147 (0.7%) | 0/149 (0%) | |||
Rash macular | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Rash papular | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Rash pruritic | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Rosacea | 1/665 (0.2%) | 0/147 (0%) | 0/149 (0%) | |||
Skin discolouration | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Skin exfoliation | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Skin lesion | 1/665 (0.2%) | 1/147 (0.7%) | 0/149 (0%) | |||
Skin tightness | 0/665 (0%) | 1/147 (0.7%) | 0/149 (0%) | |||
Skin ulcer | 2/665 (0.3%) | 2/147 (1.4%) | 1/149 (0.7%) | |||
Swelling face | 2/665 (0.3%) | 1/147 (0.7%) | 0/149 (0%) | |||
Vascular disorders | ||||||
Hypertension | 2/665 (0.3%) | 1/147 (0.7%) | 0/149 (0%) | |||
Hypotension | 3/665 (0.5%) | 1/147 (0.7%) | 0/149 (0%) | |||
Intermittent claudication | 0/665 (0%) | 0/147 (0%) | 1/149 (0.7%) | |||
Peripheral vascular disorder | 0/665 (0%) | 2/147 (1.4%) | 0/149 (0%) |
Limitations/Caveats
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Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title | Pfizer ClinicalTrials.gov Call Center |
---|---|
Organization | Pfizer, Inc. |
Phone | 1-800-718-1021 |
ClinicalTrials.gov_Inquiries@pfizer.com |
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