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NCT01898013 · ClinicalTrials.gov registry record · Phase 2
Neurosteroids as Novel Therapeutic Agents for Chronic Pain in OEF/OIF Veterans
A Phase 2 study, sponsored by Durham VA Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 94
- Enrollment target
NCT01898013 is a Phase 2 study that has completed, run by Durham VA Medical Center. The registered enrollment target is 94 participants.
The verdict
NCT01898013, a Phase 2 study, has completed, sponsored by Durham VA Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 94 participants
- Enrollment target
Study Summary
The study design is a randomized, double-blind, two-arm trial of pregnenolone and placebo to determine the possible analgesic effects in OEF/OIF Veterans with chronic low back pain. The total study duration is 6 weeks (followed by two-follow up phone calls). All patients will monitor pain symptoms for one week with pain diaries, followed by a 1-week placebo-only lead-in period, 90 subjects will be randomly assigned to one of two groups. Of these subjects, 45 subjects will receive pregnenolone, and 45 subjects will receive placebo for 4 weeks. Patient interview assessments and laboratory studies will be performed at each interview time point. Pregnenolone, allopregnanolone and other neurosteroid metabolites will be determined by gas chromatography / mass spectrometry (GC/MS), proceeded by high performance liquid chromatography (HPLC).
Interventions
- DRUG Placebo
- DRUG Pregnenolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2013-09-13 |
| Est. Completion | 2017-04-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01898013
The ClinicalTrials.gov registry entry for NCT01898013 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Durham VA Medical Center, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01898013 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01898013 about?
NCT01898013 is a clinical study titled "Neurosteroids as Novel Therapeutic Agents for Chronic Pain in OEF/OIF Veterans". The study design is a randomized, double-blind, two-arm trial of pregnenolone and placebo to determine the possible analgesic effects in OEF/OIF Veterans with chronic low back pain. The total study duration is 6 weeks (followed by two-follow up phone calls). All patients will monitor pain symptoms f...
What is the current status of trial NCT01898013?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 94 participants. The study started on 2013-09-13. Estimated completion is 2017-04-03.
What interventions are being tested in trial NCT01898013?
The interventions under investigation include: Placebo (DRUG), Pregnenolone (DRUG).
Who is sponsoring clinical trial NCT01898013?
This trial is sponsored by Durham VA Medical Center, which has 17 total clinical trials registered on ClinicalTrials.gov.
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