Phase 2 Study of TD-9855 to Treat Fibromyalgia
Sponsor
Theravance Biopharma (Industry)
Overall Status
Completed
CT.gov ID
NCT01693692
Collaborator
(none)
392
34
3
17
11.5
0.7
Study Details
Study Description
Brief Summary
The purpose of this study study is to determine whether TD-9855 is effective in treating patients with fibromyalgia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
392 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of TD-9855 in Patients With Fibromyalgia (FM)
Actual Study Start Date
:
Nov 1, 2012
Actual Primary Completion Date
:
Jan 1, 2014
Actual Study Completion Date
:
Apr 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TD-9855 Group 1 Group 1 to be dosed with TD-9855 |
Drug: TD-9855 Group 1
|
| Experimental: TD-9855 Group 2 Group 2 to be dosed with TD-9855 |
Drug: TD-9855 Group 2
|
| Placebo Comparator: Placebo Group to be dosed with Placebo |
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- Percentage Change in Pain Score Based on the Mean of the Last 7 Daily Pain Numeric Rating Scale (NRS) Scores From the Daily Pain Diaries [Baseline and Week 6]
Pain NRS score is based on an 11-point scale where 0 represents no pain and 10 represents the worst possible pain.
Secondary Outcome Measures
- Fibromyalgia Impact Questionnaire (FIQ) [Day 43 (End of study treatment)]
FIQ score is based on the total score from 0 to 100 gained from 10 questions, where a lower total score represents less impact from fibromyalgia.
- Patient Global Impression of Change (PGIC) [Day 43 (End of study treatment)]
PGIC score is based on a 7-category scale where a score of 1 indicates the participant's condition is very much improved, and a score of 7 indicates the participant's condition is very much worse.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
• American College of Rheumatology (ACR) Diagnostic Criteria for Fibromyalgia (FM)
-
Informed consent
-
18 to 65 years of age
-
Discontinue therapy with adrenergic-acting drugs, and certain other medications
-
Only acetaminophen or NSAID as rescue pain medication
-
No narcotic pain meds or benzodiazepines
-
Only non-benzodiazepines as rescue hypnotics
Exclusion Criteria:
-
Any current psychiatric disorder, lifetime bipolar disorder, severe comorbid Axis II disorder, mental retardation, etc, as assessed by Mini International Neuropsychiatric Interview (MINI)
-
Major depression at screening by MINI when unable to be washed out of MDD meds (investigator or provider's judgment)
-
Risk of suicide (investigator opinion and/or C-SSRS)
-
Recent history of substance or alcohol abuse
-
BMI <18 or ≥45
-
Concurrent disease; pain for diagnosed illness other than FM; non-compliance; history of seizures; pheochromocytoma; glaucoma; CV disease; orthostatic hypotension or orthostatic tachycardia; untreated sleep apnea
-
Abnormal lab values (liver, kidney, thyroid, and others)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rheumatology Associates of North Alabama, PC | Huntsville | Alabama | United States | 35801 |
| 2 | Dedicated Clinical Research | Goodyear | Arizona | United States | 85395 |
| 3 | TriWest Research Associates, LLC | El Cajon | California | United States | 92020 |
| 4 | Arroyo Medical Group, Inc. | Pismo Beach | California | United States | 93449 |
| 5 | Diablo Clinical Research, Inc. | Walnut Creek | California | United States | 94598 |
| 6 | Coastal Connecticut Research, LLC | New London | Connecticut | United States | 06320 |
| 7 | Florida Clinical Research Center, LLC | Bradenton | Florida | United States | 34201 |
| 8 | PAB Clinical Research | Brandon | Florida | United States | 33511 |
| 9 | Meridien Research | Lakeland | Florida | United States | 33805 |
| 10 | Renstar Medical Research | Ocala | Florida | United States | 34471 |
| 11 | Compass Research, LLC | Orlando | Florida | United States | 32806 |
| 12 | Clinical Investigation Specialists, Inc. | Gurnee | Illinois | United States | 60031 |
| 13 | MediSphere Medical Research Center, LLC | Evansville | Indiana | United States | 47714 |
| 14 | GTC Research | Shawnee Mission | Kansas | United States | 66218 |
| 15 | Beacon Clinical Research | Brockton | Massachusetts | United States | 02301 |
| 16 | Beacon Clinical Research | New Bedford | Massachusetts | United States | 02740 |
| 17 | The Center for Pharmaceutical Research | Kansas City | Missouri | United States | 64114 |
| 18 | Meridian Clinical Research | Omaha | Nebraska | United States | 68134 |
| 19 | Advanced Biomedical Research of America | Las Vegas | Nevada | United States | 89123 |
| 20 | Upstate Clinical Research Associates, LLC | Williamsville | New York | United States | 14221 |
| 21 | Wake Research Associates | Raleigh | North Carolina | United States | 27612 |
| 22 | The Center for Clinical Research | Winston-Salem | North Carolina | United States | 27103 |
| 23 | Lillestol Research, LLC | Fargo | North Dakota | United States | 58103 |
| 24 | University of Cincinnati | Cincinnati | Ohio | United States | 45219 |
| 25 | Clinical Research Source, Inc. | Perrysburg | Ohio | United States | 43551 |
| 26 | Tulsa Clinical Research, LLC | Tulsa | Oklahoma | United States | 74104 |
| 27 | Sunstone Medical Research, LLC | Medford | Oregon | United States | 97504 |
| 28 | Altoona Center for Clinical Research | Duncansville | Pennsylvania | United States | 16635 |
| 29 | Omega Medical Research | Warwick | Rhode Island | United States | 02886 |
| 30 | Coastal Carolina Research Center | Mount Pleasant | South Carolina | United States | 29464 |
| 31 | Carolina Center for Rheumatology & Arthritis Care | Rock Hill | South Carolina | United States | 29732 |
| 32 | Meridian Clinical Research | Dakota Dunes | South Dakota | United States | 57049 |
| 33 | ClinSearch, LLC | Chattanooga | Tennessee | United States | 37421 |
| 34 | Swedish Rheumatology Research | Seattle | Washington | United States | 98104 |
Sponsors and Collaborators
- Theravance Biopharma
Investigators
- Study Director: Medical Monitor, Theravance Biopharma
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Theravance Biopharma
ClinicalTrials.gov Identifier:
NCT01693692
Other Study ID Numbers:
- 0092
First Posted:
Sep 26, 2012
Last Update Posted:
Mar 4, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Theravance Biopharma
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 392 participants were enrolled across 53 study sites in the United States. |
|---|---|
| Pre-assignment Detail | 392 participants were enrolled, but 9 participants were not treated with the study drug. |
| Arm/Group Title | Placebo | TD-9855 Group 1 | TD-9855 Group 2 |
|---|---|---|---|
| Arm/Group Description | Participants will be administered a placebo once daily for 6 weeks. | Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study. | Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study. |
| Period Title: Overall Study | |||
| STARTED | 130 | 131 | 131 |
| Received Study Drug | 128 | 127 | 128 |
| COMPLETED | 100 | 97 | 95 |
| NOT COMPLETED | 30 | 34 | 36 |
Baseline Characteristics
| Arm/Group Title | Placebo | TD-9855 Group 1 | TD-9855 Group 2 | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants will be administered a placebo once daily for 6 weeks. | Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study. | Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study. | Total of all reporting groups |
| Overall Participants | 130 | 131 | 131 | 392 |
| Age (years) [Mean (Full Range) ] | ||||
| Mean (Full Range) [years] |
45.8
|
48.0
|
43.2
|
45.7
|
| Age, Customized (Count of Participants) | ||||
| 18 - 45 Years of Age |
55
42.3%
|
51
38.9%
|
73
55.7%
|
179
45.7%
|
| 46 - 65 Years of Age |
75
57.7%
|
80
61.1%
|
58
44.3%
|
213
54.3%
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
123
94.6%
|
123
93.9%
|
123
93.9%
|
369
94.1%
|
| Male |
7
5.4%
|
8
6.1%
|
8
6.1%
|
23
5.9%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
22
16.9%
|
16
12.2%
|
19
14.5%
|
57
14.5%
|
| Not Hispanic or Latino |
106
81.5%
|
115
87.8%
|
112
85.5%
|
333
84.9%
|
| Unknown or Not Reported |
2
1.5%
|
0
0%
|
0
0%
|
2
0.5%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
2
1.5%
|
0
0%
|
1
0.8%
|
3
0.8%
|
| Asian |
1
0.8%
|
0
0%
|
1
0.8%
|
2
0.5%
|
| Native Hawaiian or Other Pacific Islander |
1
0.8%
|
0
0%
|
0
0%
|
1
0.3%
|
| Black or African American |
13
10%
|
18
13.7%
|
20
15.3%
|
51
13%
|
| White |
110
84.6%
|
107
81.7%
|
107
81.7%
|
324
82.7%
|
| More than one race |
2
1.5%
|
6
4.6%
|
1
0.8%
|
9
2.3%
|
| Unknown or Not Reported |
1
0.8%
|
0
0%
|
1
0.8%
|
2
0.5%
|
| Region of Enrollment (participants) [Number] | ||||
| United States |
130
100%
|
131
100%
|
131
100%
|
392
100%
|
| Weight (kg) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [kg] |
81.9
(17.64)
|
83.2
(17.68)
|
79.0
(17.27)
|
81.4
(17.57)
|
| Height (cm) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [cm] |
163.3
(6.85)
|
164.5
(7.65)
|
164.0
(8.49)
|
164.0
(7.69)
|
| Body Mass Index (kg/m^2) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [kg/m^2] |
30.7
(6.24)
|
30.7
(5.74)
|
29.3
(5.59)
|
30.2
(5.89)
|
Outcome Measures
| Title | Percentage Change in Pain Score Based on the Mean of the Last 7 Daily Pain Numeric Rating Scale (NRS) Scores From the Daily Pain Diaries |
|---|---|
| Description | Pain NRS score is based on an 11-point scale where 0 represents no pain and 10 represents the worst possible pain. |
| Time Frame | Baseline and Week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only participants with available data were used for this analysis. |
| Arm/Group Title | Placebo | TD-9855 Group 1 | TD-9855 Group 2 |
|---|---|---|---|
| Arm/Group Description | Participants will be administered a placebo once daily for 6 weeks. | Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study. | Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study. |
| Measure Participants | 126 | 122 | 125 |
| Least Squares Mean (Standard Error) [percentage change] |
-0.9
(0.17)
|
-1.2
(0.18)
|
-1.4
(0.17)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, TD-9855 Group 1 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1683 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.24 | |
| Confidence Interval |
(1-Sided) 95% to 0.2 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.25 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, TD-9855 Group 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0277 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.47 | |
| Confidence Interval |
(1-Sided) 95% to -0.1 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.25 |
|
| Estimation Comments | ||
| Title | Fibromyalgia Impact Questionnaire (FIQ) |
|---|---|
| Description | FIQ score is based on the total score from 0 to 100 gained from 10 questions, where a lower total score represents less impact from fibromyalgia. |
| Time Frame | Day 43 (End of study treatment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only participants with available data were used for this analysis. |
| Arm/Group Title | Placebo | TD-9855 Group 1 | TD-9855 Group 2 |
|---|---|---|---|
| Arm/Group Description | Participants will be administered a placebo once daily for 6 weeks. | Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study. | Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study. |
| Measure Participants | 126 | 122 | 125 |
| Least Squares Mean (Standard Deviation) [score on a scale] |
44.0
(1.75)
|
42.4
(1.75)
|
38.2
(1.75)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, TD-9855 Group 1 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.2637 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -1.57 | |
| Confidence Interval |
(1-Sided) 95% to 2.5 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.48 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, TD-9855 Group 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0097 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -5.80 | |
| Confidence Interval |
(1-Sided) 95% to -1.7 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 2.47 |
|
| Estimation Comments | ||
| Title | Patient Global Impression of Change (PGIC) |
|---|---|
| Description | PGIC score is based on a 7-category scale where a score of 1 indicates the participant's condition is very much improved, and a score of 7 indicates the participant's condition is very much worse. |
| Time Frame | Day 43 (End of study treatment) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only participants with available data were used for this analysis. |
| Arm/Group Title | Placebo | TD-9855 Group 1 | TD-9855 Group 2 |
|---|---|---|---|
| Arm/Group Description | Participants will be administered a placebo once daily for 6 weeks. | Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study. | Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study. |
| Measure Participants | 126 | 122 | 125 |
| Least Squares Mean (Standard Error) [score on a scale] |
3.2
(0.11)
|
2.9
(0.11)
|
2.8
(0.11)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, TD-9855 Group 1 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0639 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.24 | |
| Confidence Interval |
(1-Sided) 95% to 0.0 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, TD-9855 Group 2 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0070 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -0.39 | |
| Confidence Interval |
(1-Sided) 95% to -0.1 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.16 |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | Day 1 up to Day 63 | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Only data from participants who received study drug or placebo is included here. | |||||
| Arm/Group Title | Placebo | TD-9855 Group 1 | TD-9855 Group 2 | |||
| Arm/Group Description | Participants will be administered a placebo once daily for 6 weeks. | Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study. | Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study. | |||
All Cause Mortality |
||||||
| Placebo | TD-9855 Group 1 | TD-9855 Group 2 | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/128 (0%) | 0/127 (0%) | 0/128 (0%) | |||
Serious Adverse Events |
||||||
| Placebo | TD-9855 Group 1 | TD-9855 Group 2 | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/128 (0%) | 1/127 (0.8%) | 1/128 (0.8%) | |||
| Cardiac disorders | ||||||
| Supraventricular tachycardia | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Nervous system disorders | ||||||
| Transient neurological symptoms of unknown etiology | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Placebo | TD-9855 Group 1 | TD-9855 Group 2 | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 71/128 (55.5%) | 78/127 (61.4%) | 90/128 (70.3%) | |||
| Blood and lymphatic system disorders | ||||||
| Leukocytosis | 0/128 (0%) | 1/127 (0.8%) | 1/128 (0.8%) | |||
| Anaemia | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Lymphadenopathy | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Macrocytosis | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Cardiac disorders | ||||||
| Tachycardia | 0/128 (0%) | 2/127 (1.6%) | 7/128 (5.5%) | |||
| Palpitations | 1/128 (0.8%) | 2/127 (1.6%) | 4/128 (3.1%) | |||
| Postural orthostatic tachycardia syndrome | 0/128 (0%) | 0/127 (0%) | 2/128 (1.6%) | |||
| Atrioventricular block first degree | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Ear and labyrinth disorders | ||||||
| Vertigo | 2/128 (1.6%) | 2/127 (1.6%) | 0/128 (0%) | |||
| Ear pain | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Motion sickness | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Tinnitus | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Endocrine disorders | ||||||
| Hypothyroidism | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Eye disorders | ||||||
| Vision blurred | 0/128 (0%) | 4/127 (3.1%) | 1/128 (0.8%) | |||
| Dry eye | 1/128 (0.8%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Blindness transient | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Cataract | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Conjunctivitis | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Visual impairment | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Gastrointestinal disorders | ||||||
| Nausea | 9/128 (7%) | 11/127 (8.7%) | 10/128 (7.8%) | |||
| Constipation | 1/128 (0.8%) | 6/127 (4.7%) | 12/128 (9.4%) | |||
| Diarrhoea | 6/128 (4.7%) | 5/127 (3.9%) | 3/128 (2.3%) | |||
| Vomiting | 4/128 (3.1%) | 3/127 (2.4%) | 4/128 (3.1%) | |||
| Dry mouth | 2/128 (1.6%) | 2/127 (1.6%) | 5/128 (3.9%) | |||
| Abdominal pain | 0/128 (0%) | 2/127 (1.6%) | 1/128 (0.8%) | |||
| Dyspepsia | 0/128 (0%) | 1/127 (0.8%) | 2/128 (1.6%) | |||
| Abdominal pain upper | 1/128 (0.8%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Abdominal distension | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Abdominal pain lower | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Abdominal tenderness | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Dental discomfort | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Dysphagia | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Gastroesophageal reflux disease | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Gingival swelling | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Infrequent bowel movements | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Lip dry | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Lip pain | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Rectal haemorrhage | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| General disorders | ||||||
| Insomnia | 4/128 (3.1%) | 7/127 (5.5%) | 11/128 (8.6%) | |||
| Fatigue | 4/128 (3.1%) | 6/127 (4.7%) | 9/128 (7%) | |||
| Decreased appetite | 1/128 (0.8%) | 4/127 (3.1%) | 7/128 (5.5%) | |||
| Alanine aminotransferase increased | 1/128 (0.8%) | 7/127 (5.5%) | 0/128 (0%) | |||
| Irritability | 1/128 (0.8%) | 2/127 (1.6%) | 1/128 (0.8%) | |||
| Oedema peripheral | 2/128 (1.6%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Pyrexia | 0/128 (0%) | 2/127 (1.6%) | 1/128 (0.8%) | |||
| Non-cardiac chest pain | 0/128 (0%) | 2/127 (1.6%) | 0/128 (0%) | |||
| Pain | 1/128 (0.8%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Asthenia | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Chills | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Sluggishness | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Tenderness | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Xerosis | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Hepatobiliary disorders | ||||||
| Hepatic steatosis | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Hyperbilirubinaemia | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Immune system disorders | ||||||
| Drug hypersensitivity | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Hypersensitivity | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Seasonal allergy | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Infections and infestations | ||||||
| Urinary tract infection | 2/128 (1.6%) | 9/127 (7.1%) | 5/128 (3.9%) | |||
| Nasopharyngitis | 1/128 (0.8%) | 1/127 (0.8%) | 8/128 (6.3%) | |||
| Upper respiratory tract infection | 4/128 (3.1%) | 3/127 (2.4%) | 4/128 (3.1%) | |||
| Gastroenteritis viral | 2/128 (1.6%) | 0/127 (0%) | 2/128 (1.6%) | |||
| Gastroenteritis | 0/128 (0%) | 1/127 (0.8%) | 2/128 (1.6%) | |||
| Sinusitis | 1/128 (0.8%) | 1/127 (0.8%) | 1/128 (0.8%) | |||
| Lower respiratory tract infection | 1/128 (0.8%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Vaginal infection | 0/128 (0%) | 0/127 (0%) | 2/128 (1.6%) | |||
| Acute sinusitis | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Bacteriuria | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Bronchitis | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Ear infection | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Fungal infection | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Gingival infection | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Hordeolum | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Influenza | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Laryngitis | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Oral herpes | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Periumbilical abscess | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Pharyngitis | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Pneumonia | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Rhinitis | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Tooth abscess | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Tooth infection | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Muscle strain | 0/128 (0%) | 1/127 (0.8%) | 2/128 (1.6%) | |||
| Contusion | 1/128 (0.8%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Ligament sprain | 0/128 (0%) | 0/127 (0%) | 2/128 (1.6%) | |||
| Animal bite | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Excoriation | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Joint injury | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Limb injury | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Post-traumatic pain | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Procedural dizziness | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Procedural pain | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Wound | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Investigations | ||||||
| Blood pressure increased | 2/128 (1.6%) | 2/127 (1.6%) | 2/128 (1.6%) | |||
| Aspartate aminotransferase increased | 1/128 (0.8%) | 4/127 (3.1%) | 0/128 (0%) | |||
| Gamma-glutamyltransferase increase | 0/128 (0%) | 3/127 (2.4%) | 1/128 (0.8%) | |||
| Heart rate increased | 0/128 (0%) | 1/127 (0.8%) | 1/128 (0.8%) | |||
| Urinary sediment present | 0/128 (0%) | 0/127 (0%) | 2/128 (1.6%) | |||
| Weight decreased | 0/128 (0%) | 2/127 (1.6%) | 0/128 (0%) | |||
| Weight increased | 0/128 (0%) | 1/127 (0.8%) | 1/128 (0.8%) | |||
| Blood alkaline phosphatase increased | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Blood creatine increased | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Blood pressure decreased | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Blood thyroid stimulating hormone increased | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Cardiac murmur | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Heart sounds abnormal | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Hepatic enzyme increased | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Dehydration | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Gout | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Hyperkalaemia | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Hypoglycaemia | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Hypovitaminosis | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Increased appetite | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Salt craving | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Type 2 diabetes mellitus | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 3/128 (2.3%) | 4/127 (3.1%) | 3/128 (2.3%) | |||
| Arthralgia | 4/128 (3.1%) | 1/127 (0.8%) | 1/128 (0.8%) | |||
| Pain in extremity | 2/128 (1.6%) | 3/127 (2.4%) | 0/128 (0%) | |||
| Neck pain | 2/128 (1.6%) | 2/127 (1.6%) | 0/128 (0%) | |||
| Joint swelling | 1/128 (0.8%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Limb discomfort | 0/128 (0%) | 2/127 (1.6%) | 0/128 (0%) | |||
| Muscle spasms | 2/128 (1.6%) | 0/127 (0%) | 0/128 (0%) | |||
| Muscle twitching | 1/128 (0.8%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Muscular weakness | 0/128 (0%) | 1/127 (0.8%) | 1/128 (0.8%) | |||
| Bursitis | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Coccydynia | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Invertebral disc protrusion | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Musculoskeletal chest pain | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Musculoskeletal pain | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Musculoskeletal stiffness | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Myalgia | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Osteoarthritis | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Synovial cyst | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Tendonitis | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Lung neoplasm | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Nervous system disorders | ||||||
| Headache | 10/128 (7.8%) | 10/127 (7.9%) | 17/128 (13.3%) | |||
| Dizziness | 5/128 (3.9%) | 7/127 (5.5%) | 13/128 (10.2%) | |||
| Disturbance in attention | 0/128 (0%) | 5/127 (3.9%) | 0/128 (0%) | |||
| Migraine | 1/128 (0.8%) | 2/127 (1.6%) | 2/128 (1.6%) | |||
| Sinus headache | 2/128 (1.6%) | 3/127 (2.4%) | 0/128 (0%) | |||
| Somnolence | 3/128 (2.3%) | 1/127 (0.8%) | 1/128 (0.8%) | |||
| Tremor | 0/128 (0%) | 1/127 (0.8%) | 2/128 (1.6%) | |||
| Dysgeusia | 0/128 (0%) | 2/127 (1.6%) | 0/128 (0%) | |||
| Hypoaesthesia | 1/128 (0.8%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Memory impairment | 0/128 (0%) | 1/127 (0.8%) | 1/128 (0.8%) | |||
| Sciatica | 1/128 (0.8%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Sedation | 1/128 (0.8%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Dysaesthesia | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Hyporeflexia | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Loss of consciousness | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Neurological symptom | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Paraesthesia | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Restless legs syndrome | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Syncope | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Tension headache | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Psychiatric disorders | ||||||
| Anxiety | 2/128 (1.6%) | 3/127 (2.4%) | 3/128 (2.3%) | |||
| Abnormal dreams | 0/128 (0%) | 2/127 (1.6%) | 0/128 (0%) | |||
| Affect lability | 2/128 (1.6%) | 0/127 (0%) | 0/128 (0%) | |||
| Sleep disorder | 0/128 (0%) | 0/127 (0%) | 2/128 (1.6%) | |||
| Depressed mood | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Depression | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Euphoric mood | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Hallucination | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Hostility | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Illusion | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Libido decreased | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Suicidal ideation | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Thinking abnormal | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Renal and urinary disorders | ||||||
| Haematuria | 0/128 (0%) | 3/127 (2.4%) | 0/128 (0%) | |||
| Micturition urgency | 0/128 (0%) | 0/127 (0%) | 2/128 (1.6%) | |||
| Nephrolithiasis | 1/128 (0.8%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Cystitis interstitial | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Dysuria | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Nocturia | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Pollakiuria | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Proteinuria | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Stress urinary incontinence | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Urine flow decreased | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Reproductive system and breast disorders | ||||||
| Amenorrhoea | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Dysmenorrhoea | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Hypomenorrhoea | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Menstrual disorder | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Menstruation delayed | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Testicular pain | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Vaginal discharge | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Vaginal haemorrhage | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 2/128 (1.6%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Dyspnoea | 1/128 (0.8%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Oropharyngeal pain | 1/128 (0.8%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Asthma | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Choking | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Epistaxis | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Nasal congestion | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Oropharyngeal discomfort | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Rhinorrhoea | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Wheezing | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Dermatitis contact | 0/128 (0%) | 3/127 (2.4%) | 1/128 (0.8%) | |||
| Hyperhidrosis | 0/128 (0%) | 1/127 (0.8%) | 3/128 (2.3%) | |||
| Rash | 0/128 (0%) | 1/127 (0.8%) | 3/128 (2.3%) | |||
| Pruritus | 0/128 (0%) | 1/127 (0.8%) | 2/128 (1.6%) | |||
| Urticaria | 1/128 (0.8%) | 2/127 (1.6%) | 0/128 (0%) | |||
| Night sweats | 0/128 (0%) | 2/127 (1.6%) | 0/128 (0%) | |||
| Acne | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Dermal cyst | 1/128 (0.8%) | 0/127 (0%) | 0/128 (0%) | |||
| Ecchymosis | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Photosensitivity reaction | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Rash erythematous | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Skin hypopigmentation | 0/128 (0%) | 0/127 (0%) | 1/128 (0.8%) | |||
| Swelling face | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Vascular disorders | ||||||
| Hot flush | 0/128 (0%) | 2/127 (1.6%) | 4/128 (3.1%) | |||
| Orthostatic hypotension | 0/128 (0%) | 1/127 (0.8%) | 3/128 (2.3%) | |||
| Flushing | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
| Hypotension | 0/128 (0%) | 1/127 (0.8%) | 0/128 (0%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Medical Monitor |
|---|---|
| Organization | Theravance Biopharma |
| Phone | 1-855-633-8479 |
| medinfo@theravance.com |
Responsible Party:
Theravance Biopharma
ClinicalTrials.gov Identifier:
NCT01693692
Other Study ID Numbers:
- 0092
First Posted:
Sep 26, 2012
Last Update Posted:
Mar 4, 2022
Last Verified:
Feb 1, 2022