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NCT01271933 · ClinicalTrials.gov registry record · Phase 3
Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients
A Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 3
- Development phase
- 441
- Enrollment target
NCT01271933: Completed Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT01271933 is a Phase 3 study that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 441 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01271933, a Phase 3 study, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 441 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of a controlled release formulation of pregabalin administered once daily as compared to placebo in the treatment of fibromyalgia. All patients will receive pregabalin; half of the patients will receive placebo at some point in the study.
Primary Outcome
The time to loss of therapeutic response (LTR) is the time to loss of pain response (\<30% pain response relative to the single-blind (SB) baseline mean pain) or withdrawal due to lack of efficacy or adverse events (in the double blind phase).
Interventions
- DRUG placebo
- DRUG pregabalin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 441 participants |
| Start Date | 2011-03 |
| Est. Completion | 2012-07 |
| Phase | Phase 3 |
What the finished NCT01271933 record still lists
NCT01271933 is an interventional study that assigns participants to a tested intervention. The registered 441 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01271933 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01271933 about?
NCT01271933 is a clinical study titled "Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients". The purpose of this study is to evaluate the efficacy and safety of a controlled release formulation of pregabalin administered once daily as compared to placebo in the treatment of fibromyalgia. All patients will receive pregabalin; half of the patients will receive placebo at some point in the stu...
What is the current status of trial NCT01271933?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 441 participants. The study started on 2011-03. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01271933?
The interventions under investigation include: placebo (DRUG), pregabalin (DRUG).
Who is sponsoring clinical trial NCT01271933?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01271933's enrollment target sits among peer trials
441 867th of 2000 higher than 1,134 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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