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NCT01020474 · ClinicalTrials.gov registry record · Phase 4
Adolescent Fibromyalgia Study
A Phase 4 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 4
- Development phase
- 107
- Enrollment target
NCT01020474: Completed Phase 4 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT01020474 is a Phase 4 study that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 107 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01020474, a Phase 4 study, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 107 participants
- Enrollment target
Study Summary
This study will compare pregabalin with placebo over a 15 week period in adolescents with fibromyalgia aged 12-17 years to evaluate the safety and efficacy of pregabalin.
Primary Outcome
The Primary Endpoint is based on the daily pain diary, and is defined as change from baseline to Week 15 in mean pain diary score. The daily pain diary consists of an 11-point numeric rating scale ranging from zero (no pain) to 10 (worst possible pain). The patients rate their pain during the past 24 hours by choosing the appropriate number between 0 ("no pain") and 10 ("worst possible pain").
Interventions
- DRUG placebo
- DRUG pregabalin (Lyrica)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2010-05 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
What the finished NCT01020474 record still lists
NCT01020474 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01020474 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01020474 about?
NCT01020474 is a clinical study titled "Adolescent Fibromyalgia Study". This study will compare pregabalin with placebo over a 15 week period in adolescents with fibromyalgia aged 12-17 years to evaluate the safety and efficacy of pregabalin.
What is the current status of trial NCT01020474?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 107 participants. The study started on 2010-05. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01020474?
The interventions under investigation include: placebo (DRUG), pregabalin (Lyrica) (DRUG).
Who is sponsoring clinical trial NCT01020474?
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 NCT01020474's enrollment target sits among peer trials
107 745th of 2000 higher than 1,254 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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