A Phase 3 interventional study of pregabalin in Peripheral Neuropathy and HIV Infections, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 37 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-22.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (part of Viatris Inc.) · Phase 3, Interventional, and Treatment
To evaluate the safety and efficacy of pregabalin in reducing neuropathic pain associated with HIV neuropathy
1,006 studies on the registry are indexed under Peripheral Nervous System Diseases; 179 are open to participants now.
This study's enrollment of 220 is above the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 434 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
First submitted before Pfizer's Upjohn has merged with Mylan to form Viatris Inc. became part of Viatris Inc..
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Exclusion Criteria:
Drug: pregabalin
75mg BID, titrated up to 300mg according to individual response and tolerability
Mean Visual Analogue Scale (VAS) Pain Scores
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.
Time frame: Baseline, Week 4, Week 8, Week 12, and Endpoint
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.
| Milestone | Pregabalin |
|---|---|
| Started | 220 |
| Completed | 190 |
| Not completed | 30 |
| Withdrew: Adverse event | 6 |
| Withdrew: Lost to follow-up | 6 |
| Withdrew: Protocol violation | 11 |
| Withdrew: Withdrawal by subject | 7 |
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.
| score on scale | Pregabalin |
|---|---|
| Baseline (n=203) | 38.61 ± 27.10 |
| Week 4 (n=204) | 30.75 ± 25.19 |
| Week 8 (n=200) | 30.16 ± 25.78 |
| Week 12 (n=207) | 28.95 ± 26.05 |
| Endpoint (n=217) | 29.39 ± 26.32 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pregabalin | — | — | — |
| Event | Pregabalin |
|---|---|
| CellulitisInfections and infestations | 2/220 |
| PneumoniaInfections and infestations | 1/220 |
| Alcohol poisoningInjury, poisoning and procedural complications | 1/220 |
| Chest painGeneral disorders | 1/220 |
| Ankle fractureInjury, poisoning and procedural complications | 1/220 |
| SyncopeNervous system disorders | 1/220 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/220 |
| Abscess limbInfections and infestations | 1/220 |
| Streptococcal infectionInfections and infestations | 1/220 |
| PancreatitisGastrointestinal disorders | 1/220 |
| Event | Pregabalin |
|---|---|
| DizzinessNervous system disorders | 22/220 |
| SomnolenceNervous system disorders | 21/220 |
| Peripheral edemaGeneral disorders | 13/220 |
| DiarrheaGastrointestinal disorders | 12/220 |
| FatigueGeneral disorders | 11/220 |
| Euphoric moodPsychiatric disorders | 8/220 |
| HeadacheNervous system disorders | 8/220 |
| CoughRespiratory, thoracic and mediastinal disorders | 7/220 |
| Dry mouthGastrointestinal disorders | 7/220 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 7/220 |
| Age, Continuous(years) | Pregabalin |
|---|---|
| Mean | 48.3 ± 7.8 |
| Sex: Female, Male(Participants) | Pregabalin |
|---|---|
| Female | 42 |
| Male | 178 |
The record gives a start of Feb 2006, a primary completion of Feb 2008 and a completion of Feb 2008. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2009, 1 year 1 month after primary completion.
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This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pregabalin
Peripheral Nervous System Diseases →
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. →