A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Postherpetic Neuralgia

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00424372
• Collaborator: (none)
• Enrollment: 126
• Locations: 33
• Arm: 1
• Actual Duration (Months): 19.2
• Patients Per Site: 3.8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

To evaluate the safety of the long-term use of pregabalin.

Condition or Disease	Intervention/Treatment	Phase
Neuralgia, Postherpetic	Drug: pregabalin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 126 participants
• Allocation: Non-Randomized
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A LONG-TERM STUDY TO EVALUATE SAFETY AND EFFICACY STUDY OF PREGABALIN IN THE TREATMENT OF POSTHERPETIC NEURALGIA.
• Actual Study Start Date: Jan 12, 2007
• Actual Primary Completion Date: Aug 19, 2008
• Actual Study Completion Date: Aug 19, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pregabalin	Drug: pregabalin; Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks

Outcome Measures

Primary Outcome Measures

1. Summary of Adverse Events [52 weeks]

   Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects are counted only once per treatment in each row.

Secondary Outcome Measures

1. Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score [52 weeks]

   Score ranges: 0-33. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.

2. Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score [52 weeks]

   Score ranges: 0-12. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.

3. Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score [52 weeks]

   Score ranges: 0-45. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.

4. Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity [52 weeks]

   Score ranges: 0-5. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.

5. Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale [52 weeks]

   Ranges: 0-100 mm. Larger scale indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients who completed the 13-week treatment of postherpetic neuralgia in Study A0081120.

• Patients must be able to understand and cooperate with study procedures and have signed a written informed consent prior to entering the study.

Exclusion Criteria:

• Patients who experienced serious adverse events in the preceding study (A0081120) that were determined by the investigator or the study sponsor to be causally related to the study medication.

• Patients exhibiting treatment non-compliance in the preceding study (A0081120)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Hospital Organization Nagoya Medical Center	Nagoya	Aichi	Japan	460-0001
2	Kobayashi Clinic	Urayasu	Chiba	Japan	279-0012
3	Okabe Hospital	Kasuya-gun	Fukuoka	Japan	811-2122
4	Gunma Pain Clinic Hospital	Maebashi	Gunma	Japan	379-2147
5	Takasaki Pain Clinic	Takasaki	Gunma	Japan	370-0035
6	Asahikawa Pain Clinic Hospital	Asahikawa	Hokkaido	Japan	070-0034
7	Kamui Pain Clinic	Asahikawa	Hokkaido	Japan	070-8013
8	Sapporo Asabu Clinic	Sapporo	Hokkaido	Japan	001-0045
9	Higashi Sapporo Hospital	Sapporo	Hokkaido	Japan	003-8585
10	Seimei Clinic	Akashi	Hyogo	Japan	673-0016
11	Uchida Pain Relief Clinic	Amagasaki	Hyogo	Japan	661-0012
12	National Hospital Organization Himeji Medical Center	Himeji	Hyogo	Japan	670-8520
13	National Hospital Organization Kobe Medical Center	Kobe	Hyogo	Japan	654-0155
14	Nakamura Clinic	Kobe	Hyogo	Japan	655-0854
15	National Hospital Organization Sagamihara National Hospital	Sagamihara	Kanagawa	Japan	228-8522
16	Suzuki Pain Clinic	Yokohama	Kanagawa	Japan	227-0043
17	Hajiri Pain Clinic	Yokohama	Kanagawa	Japan	236-0037
18	National Hospital Organization Yokohama Medical Center	Yokohama	Kanagawa	Japan	245-8575
19	Sendai Pain Clinic	Sendai	Miyagi	Japan	983-0036
20	Nakamura Hospital	Beppu	Ohita	Japan	874-0937
21	Kawaguchi Kogyo General Hospital	Kawaguchi	Saitama	Japan	332-0031
22	Kinoshita Clinic	Tokorozawa	Saitama	Japan	359-0038
23	Tokyo Women's Medical University Center East	Arakawa-ku	Tokyo	Japan	116-8567
24	Juntendo University Hospital	Bunkyo-ku	Tokyo	Japan	113-8431
25	Mitaka Pain Clinic	Mitaka	Tokyo	Japan	181-0013
26	Toriumi Pain Clinic	Nakano-ku	Tokyo	Japan	165-0027
27	Kanto Medical NTT East Corporation	Shinagawa-ku	Tokyo	Japan	141-0022
28	Naganuma Pain Clinic	Shinagawa-ku	Tokyo	Japan	141-0022
29	Tokyo Women's Medical University Hospital	Shinjuku-ku	Tokyo	Japan	162-8666
30	Mukai Clinic	Fukuoka		Japan	812-0011
31	KM Pain Clinic	Fukuoka		Japan	814-0001
32	Otsuki Sleep Clinic	Fukushima		Japan	960-8044
33	Hasumi Pain Clinic	Saitama		Japan	330-0805

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:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00424372
• Other Study ID Numbers: A0081121
• First Posted: Jan 19, 2007
• Last Update Posted: Aug 27, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Neuralgia; Neuralgia, Postherpetic; Pregabalin

Study Results

Participant Flow

Pre-assignment Detail	A total of 126 subjects who completed the 13-week treatment regimen in the preceding double-blind Study A0081120 and had no serious adverse events or issues with compliance were enrolled to this study.

Arm/Group Title	Pregabalin
Arm/Group Description	Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects' safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
Period Title: Overall Study
STARTED	126
COMPLETED	95
NOT COMPLETED	31

Baseline Characteristics

Arm/Group Title	Pregabalin
Arm/Group Description	Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects' safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
Overall Participants	126
Age, Customized (Subjects) [Number]
>= 18 and < 45 years	1
>= 45 and < 65 years	19
>=65 years	106
Sex: Female, Male (Count of Participants)
Female	55 43.7%
Male	71 56.3%

Outcome Measures

1. Primary Outcome

Title	Summary of Adverse Events
Description	Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects are counted only once per treatment in each row.
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Safety population: all subjects who took at least 1 dose of study medication.

Arm/Group Title	Pregabalin
Arm/Group Description	Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects' safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
Measure Participants	126
Subjects with adverse events	124
Subjects with serious adverse events	14
Subjects with severe adverse events	5
Subjects discontinued due to adverse events	17
Dose reduced or temporary discontinuation	34

2. Secondary Outcome

Title	Short-Form McGill Pain Questionnaire the Efficacy of Change: Sensory Score
Description	Score ranges: 0-33. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set, N = Number of subjects assessed

Arm/Group Title	Pregabalin
Arm/Group Description	Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects' safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
Measure Participants	126
Baseline	11.3 (7.0)
Week 52	5.1 (5.6)
Endpoint	6.7 (7.1)
Change from Baseline to Endpoint	-4.8 (5.9)

3. Secondary Outcome

Title	Short-Form McGill Pain Questionnaire the Efficacy of Change: Affective Score
Description	Score ranges: 0-12. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set, N = Number of subjects assessed

Arm/Group Title	Pregabalin
Arm/Group Description	Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects' safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
Measure Participants	126
Baseline	3.4 (3.1)
Week 52	1.0 (1.8)
Endpoint	1.7 (2.7)
Change from Baseline to Endpoint	-1.8 (2.8)

4. Secondary Outcome

Title	Short-Form McGill Pain Questionnaire the Efficacy of Change: Total Score
Description	Score ranges: 0-45. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set, N = Number of subjects assessed

Arm/Group Title	Pregabalin
Arm/Group Description	Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects' safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
Measure Participants	126
Baseline	14.7 (9.7)
Week 52	6.1 (7.2)
Endpoint	8.2 (9.6)
Change from Baseline to Endpoint	-6.5 (8.4)

5. Secondary Outcome

Title	Short-Form McGill Pain Questionnaire the Efficacy of Change: Present Pain Intensity
Description	Score ranges: 0-5. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set, N = Number of subjects assessed

Arm/Group Title	Pregabalin
Arm/Group Description	Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects' safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
Measure Participants	126
Baseline	2.8 (1.0)
Week 52	1.4 (0.9)
Endpoint	1.7 (1.1)
Change from Baseline to Endpoint	-1.1 (1.1)

6. Secondary Outcome

Title	Short-Form McGill Pain Questionnaire the Efficacy of Change: Visual Analog Scale
Description	Ranges: 0-100 mm. Larger scale indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label.
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description

Full Analysis Set, N = Number of subjects assessed

Arm/Group Title	Pregabalin
Arm/Group Description	Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects' safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
Measure Participants	126
Baseline	62.0 (19.0)
Week 52	28.3 (22.9)
Endpoint	33.7 (25.6)
Change from Baseline to Endpoint	-28.3 (23.8)

Adverse Events

Time Frame	52 weeks
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
Arm/Group Description	Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects' safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
All Cause Mortality
	Pregabalin
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Pregabalin
	Affected / at Risk (%)	# Events
Total	15/126 (11.9%)
Cardiac disorders
Atrial fibrillation	1/126 (0.8%)
Cardiac failure congestive	1/126 (0.8%)
Ear and labyrinth disorders
Vertigo	1/126 (0.8%)
Gastrointestinal disorders
Gastroduodenal ulcer	1/126 (0.8%)
General disorders
Chest pain	1/126 (0.8%)
Infections and infestations
Pneumonia	1/126 (0.8%)
Injury, poisoning and procedural complications
Heat stroke	1/126 (0.8%)
Joint dislocation	1/126 (0.8%)
Open fracture	1/126 (0.8%)
Radius fracture	1/126 (0.8%)
Spinal compression fracture	2/126 (1.6%)
Investigations
Occult blood	1/126 (0.8%)
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis	1/126 (0.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant	1/126 (0.8%)
Malignant palate neoplasm	1/126 (0.8%)
Nervous system disorders
Dizziness	1/126 (0.8%)
Headache	1/126 (0.8%)
Psychiatric disorders
Completed suicide	1/126 (0.8%)
Respiratory, thoracic and mediastinal disorders
Asthma	1/126 (0.8%)
Chronic obstructive pulmonary disease	1/126 (0.8%)
Emphysema	1/126 (0.8%)
Epistaxis	1/126 (0.8%)
Other (Not Including Serious) Adverse Events
	Pregabalin
	Affected / at Risk (%)	# Events
Total	98/126 (77.8%)
Eye disorders
Retinal haemorrhage	7/126 (5.6%)
Visual acuity reduced	7/126 (5.6%)
Gastrointestinal disorders
Constipation	12/126 (9.5%)
Diarrhoea	12/126 (9.5%)
Nausea	7/126 (5.6%)
General disorders
Oedema peripheral	22/126 (17.5%)
Infections and infestations
Nasopharyngitis	34/126 (27%)
Injury, poisoning and procedural complications
Fall	9/126 (7.1%)
Investigations
Weight increased	19/126 (15.1%)
Musculoskeletal and connective tissue disorders
Arthralgia	7/126 (5.6%)
Osteoarthritis	7/126 (5.6%)
Nervous system disorders
Dizziness	36/126 (28.6%)
Headache	7/126 (5.6%)
Somnolence	22/126 (17.5%)

Limitations/Caveats

[Not Specified]

More Information

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.