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NCT01077375 · ClinicalTrials.gov registry record · Phase 4
Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia
A Phase 4 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 4
- Development phase
- 107
- Enrollment target
NCT01077375: Completed Phase 4 study, sponsored by Forest Laboratories.
NCT01077375 is a Phase 4 study that has completed, run by Forest Laboratories. 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
NCT01077375, a Phase 4 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 107 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the safety, tolerability and efficacy of milnacipran in patients with an inadequate response to duloxetine for the treatment of fibromyalgia.
Primary Outcome
The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse). To meet the criteria for a responder in this study, patients must report a score of 1 (very much improved) or 2 (much improved) on the PGIC.
Interventions
- DRUG Placebo
- DRUG Milnacipran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2010-02 |
| Est. Completion | 2011-01 |
| Phase | Phase 4 |
What the finished NCT01077375 record still lists
NCT01077375 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.
NCT01077375 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01077375 about?
NCT01077375 is a clinical study titled "Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia". The objective of this study is to evaluate the safety, tolerability and efficacy of milnacipran in patients with an inadequate response to duloxetine for the treatment of fibromyalgia.
What is the current status of trial NCT01077375?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 107 participants. The study started on 2010-02. Estimated completion is 2011-01.
What interventions are being tested in trial NCT01077375?
The interventions under investigation include: Placebo (DRUG), Milnacipran (DRUG).
Who is sponsoring clinical trial NCT01077375?
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 NCT01077375'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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