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NCT01207453 · ClinicalTrials.gov registry record · Phase 4
Milnacipran in the Treatment of Widespread, Non-Joint Pain in Rheumatoid Arthritis
A Phase 4 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 49
- Enrollment target
NCT01207453: Completed Phase 4 study, sponsored by Brigham and Women's Hospital.
NCT01207453 is a Phase 4 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 49 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01207453, a Phase 4 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 49 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether milnacipran reduces widespread, non-joint pain in patients with rheumatoid arthritis (RA). The investigators will conduct a double-blind randomized crossover trial in subjects with RA to test the hypothesis that milnacipran improves widespread, non-joint pain. The investigators will also use data from the trial to determine whether response to milnacipran is associated with pain-modulating mechanisms from the central nervous system. The investigators hypothesize that response to milnacipran will be greater among patients with impaired central pain mechanisms than among patients with intact central pain modulating mechanisms.
Primary Outcome
A measure of change in scores on the BPI short form, a "24-hr average pain" item, from baseline to 6 weeks, The BPI short form scores ranges from 0-10, with 10 being the worst pain.
Interventions
- DRUG Placebo
- DRUG Milnacipran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2011-01 |
| Est. Completion | 2013-11 |
| Phase | Phase 4 |
What the finished NCT01207453 record still lists
NCT01207453 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01207453 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01207453 about?
NCT01207453 is a clinical study titled "Milnacipran in the Treatment of Widespread, Non-Joint Pain in Rheumatoid Arthritis". The purpose of this study is to determine whether milnacipran reduces widespread, non-joint pain in patients with rheumatoid arthritis (RA). The investigators will conduct a double-blind randomized crossover trial in subjects with RA to test the hypothesis that milnacipran improves widespread, non-j...
What is the current status of trial NCT01207453?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 49 participants. The study started on 2011-01. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01207453?
The interventions under investigation include: Placebo (DRUG), Milnacipran (DRUG).
Who is sponsoring clinical trial NCT01207453?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01207453's enrollment target sits among peer trials
49 1323rd of 2000 higher than 670 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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