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NCT00797797 · ClinicalTrials.gov registry record · Phase 3
Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia
A Phase 3 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 364
- Enrollment target
NCT00797797: Completed Phase 3 study, sponsored by Forest Laboratories.
NCT00797797 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 364 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00797797, a Phase 3 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 364 participants
- Enrollment target
Study Summary
To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another drug called pregabalin in people with fibromyalgia.
Primary Outcome
The primary efficacy parameter was the PGIC responder rate, defined as the percentage of patients who rated themselves as "very much improved" or "much improved" (ie, having a score of 1 or 2 on the 7-point scale) for the PGIC at end of study (Visit 6 or Early Termination) compared to Visit 1.
Interventions
- DRUG No Treatment Added
- DRUG Milnacipran Added
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 364 participants |
| Start Date | 2008-11 |
| Est. Completion | 2010-01 |
| Phase | Phase 3 |
What the finished NCT00797797 record still lists
NCT00797797 is an interventional study that assigns participants to a tested intervention. The registered 364 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 (53% lower).
The record links to 0 conditions, and to 2 interventions - of which No Treatment Added is the first listed.
NCT00797797 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00797797 about?
NCT00797797 is a clinical study titled "Study of Milnacipran Added to Pregabalin for Treatment of Fibromyalgia". To evaluate the safety, tolerability, and efficacy of milnacipran when taken with another drug called pregabalin in people with fibromyalgia.
What is the current status of trial NCT00797797?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 364 participants. The study started on 2008-11. Estimated completion is 2010-01.
What interventions are being tested in trial NCT00797797?
The interventions under investigation include: No Treatment Added (DRUG), Milnacipran Added (DRUG).
Who is sponsoring clinical trial NCT00797797?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00797797's enrollment target sits among peer trials
364 1003rd of 2000 higher than 996 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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