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NCT01237587 · ClinicalTrials.gov registry record · Phase 3
A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 184
- Enrollment target
NCT01237587: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT01237587 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 184 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01237587, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 184 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether duloxetine is safe and effective in the treatment of adolescents with Juvenile Primary Fibromyalgia Syndrome (JPFS). This trial consists of two distinct study periods. A blinded treatment period of 13 weeks and an open label extension period of 26 weeks.
Primary Outcome
Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and the interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours. Mixed Model Repeated Measure (MMRM) model with terms for treatment, pooled investigator, visit, baseline, treatment by visit, and baseline by visit was used to produce Least Square
Interventions
- DRUG Placebo
- DRUG Duloxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 184 participants |
| Start Date | 2011-03 |
| Est. Completion | 2017-11-28 |
| Phase | Phase 3 |
What the finished NCT01237587 record still lists
NCT01237587 is an interventional study that assigns participants to a tested intervention. The registered 184 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 (76% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01237587 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01237587 about?
NCT01237587 is a clinical study titled "A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome". The purpose of this study is to determine whether duloxetine is safe and effective in the treatment of adolescents with Juvenile Primary Fibromyalgia Syndrome (JPFS). This trial consists of two distinct study periods. A blinded treatment period of 13 weeks and an open label extension period of 26 w...
What is the current status of trial NCT01237587?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 184 participants. The study started on 2011-03. Estimated completion is 2017-11-28.
What interventions are being tested in trial NCT01237587?
The interventions under investigation include: Placebo (DRUG), Duloxetine (DRUG).
Who is sponsoring clinical trial NCT01237587?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01237587's enrollment target sits among peer trials
184 1418th of 2000 higher than 581 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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