Trial Outcomes & Findings for Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With Human Immunodeficiency Virus (HIV) Neuropathy (NCT NCT00264875)
NCT ID: NCT00264875
Last Updated: 2021-01-22
Results Overview
Pain scores were assessed on a 100 mm Visual Analogue Scale (VAS); scores range from 0= no pain to 100= worse pain. Subjects assessed their pain during the last week. Endpoint = last non-missing observation carried forward after Baseline visit.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
220 participants
Primary outcome timeframe
Baseline, Week 4, Week 8, Week 12, and Endpoint
Results posted on
2021-01-22
Participant Flow
With completion of A0081066 (NCT00232141), subjects had option of initiating treatment with pregabalin under open-label conditions for 3 months in A0081095, an open-label extension trial. Treatment in A0081095 was initiated on the evening of the subjects' Visit 7/Termination Visit in A0081066. A0081095 was conducted in the United States.
Participant milestones
| Measure |
Pregabalin
Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).
|
|---|---|
|
Overall Study
STARTED
|
220
|
|
Overall Study
COMPLETED
|
190
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
Pregabalin
Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Protocol Violation
|
11
|
|
Overall Study
Withdrawal by Subject
|
7
|
Baseline Characteristics
Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With Human Immunodeficiency Virus (HIV) Neuropathy
Baseline characteristics by cohort
| Measure |
Pregabalin
n=220 Participants
Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).
|
|---|---|
|
Age, Continuous
|
48.3 years
STANDARD_DEVIATION 7.8 • n=93 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
178 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, and EndpointPopulation: The full analysis set was defined as all subjects who met all eligibility criteria and took at least one dose of study medication.
Pain scores were assessed on a 100 mm Visual Analogue Scale (VAS); scores range from 0= no pain to 100= worse pain. Subjects assessed their pain during the last week. Endpoint = last non-missing observation carried forward after Baseline visit.
Outcome measures
| Measure |
Pregabalin
n=220 Participants
Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).
|
|---|---|
|
Mean Visual Analogue Scale (VAS) Pain Scores
Baseline (n=203)
|
38.61 score on scale
Standard Deviation 27.10
|
|
Mean Visual Analogue Scale (VAS) Pain Scores
Week 4 (n=204)
|
30.75 score on scale
Standard Deviation 25.19
|
|
Mean Visual Analogue Scale (VAS) Pain Scores
Week 8 (n=200)
|
30.16 score on scale
Standard Deviation 25.78
|
|
Mean Visual Analogue Scale (VAS) Pain Scores
Week 12 (n=207)
|
28.95 score on scale
Standard Deviation 26.05
|
|
Mean Visual Analogue Scale (VAS) Pain Scores
Endpoint (n=217)
|
29.39 score on scale
Standard Deviation 26.32
|
Adverse Events
Pregabalin
Serious events: 10 serious events
Other events: 82 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pregabalin
Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).
|
|---|---|
|
Infections and infestations
Cellulitis
|
0.91%
2/220
|
|
Infections and infestations
Pneumonia
|
0.45%
1/220
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.45%
1/220
|
|
General disorders
Chest pain
|
0.45%
1/220
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.45%
1/220
|
|
Nervous system disorders
Syncope
|
0.45%
1/220
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.45%
1/220
|
|
Infections and infestations
Abscess limb
|
0.45%
1/220
|
|
Infections and infestations
Streptococcal infection
|
0.45%
1/220
|
|
Gastrointestinal disorders
Pancreatitis
|
0.45%
1/220
|
|
Vascular disorders
Deep vein thrombosis
|
0.45%
1/220
|
Other adverse events
| Measure |
Pregabalin
Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).
|
|---|---|
|
Nervous system disorders
Dizziness
|
10.0%
22/220
|
|
Nervous system disorders
Somnolence
|
9.5%
21/220
|
|
General disorders
Peripheral edema
|
5.9%
13/220
|
|
Gastrointestinal disorders
Diarrhea
|
5.5%
12/220
|
|
General disorders
Fatigue
|
5.0%
11/220
|
|
Psychiatric disorders
Euphoric mood
|
3.6%
8/220
|
|
Nervous system disorders
Headache
|
3.6%
8/220
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.2%
7/220
|
|
Gastrointestinal disorders
Dry mouth
|
3.2%
7/220
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.2%
7/220
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
7/220
|
|
Gastrointestinal disorders
Nausea
|
2.7%
6/220
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
6/220
|
|
Infections and infestations
Upper respiratory tract infection
|
2.3%
5/220
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.3%
5/220
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.3%
5/220
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \<60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \<12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
- Publication restrictions are in place
Restriction type: OTHER