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NCT01288937 · ClinicalTrials.gov registry record · Phase 3
A Placebo Controlled, Randomized, Double Blind Trial of Milnacipran for the Treatment of Idiopathic Neuropathy Pain
A Phase 3 study, sponsored by Columbia University.
- Terminated
- Registry status
- Phase 3
- Development phase
- 6
- Enrollment target
NCT01288937 is a Phase 3 study that was terminated before completion, run by Columbia University. The registered enrollment target is 6 participants.
The verdict
NCT01288937, a Phase 3 study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 6 participants
- Enrollment target
Study Summary
This is an 11-week randomized, double-blind, placebo-controlled trial of Milnacipran 100 mg/d in patients with idiopathic neuropathic pain. Milnacipran, a dual norepinephrine and serotonin reuptake inhibitor has been a safe and beneficial treatment for patients with fibromyalgia and may be useful to treat patients with painful peripheral neuropathy. The primary outcome will be assessed by the change in daily averaged weekly 0-10 pain intensity score, from baseline to week 9, by intention to treat analysis. The same analysis will be used on several secondary measures including daily averaged weekly 0-10 pain intensity score the sleep interference scale and the Rand-36 quality of life scale.
Interventions
- DRUG Placebo
- DRUG Milnacipran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2011-04-05 |
| Est. Completion | 2014-12-23 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01288937
The ClinicalTrials.gov registry entry for NCT01288937 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01288937 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01288937 about?
NCT01288937 is a clinical study titled "A Placebo Controlled, Randomized, Double Blind Trial of Milnacipran for the Treatment of Idiopathic Neuropathy Pain". This is an 11-week randomized, double-blind, placebo-controlled trial of Milnacipran 100 mg/d in patients with idiopathic neuropathic pain. Milnacipran, a dual norepinephrine and serotonin reuptake inhibitor has been a safe and beneficial treatment for patients with fibromyalgia and may be useful to...
What is the current status of trial NCT01288937?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 6 participants. The study started on 2011-04-05. Estimated completion is 2014-12-23.
What interventions are being tested in trial NCT01288937?
The interventions under investigation include: Placebo (DRUG), Milnacipran (DRUG).
Who is sponsoring clinical trial NCT01288937?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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