Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00366535 · ClinicalTrials.gov registry record · Phase 2
Neurotropin Treatment of Fibromyalgia
A Phase 2 study, sponsored by National Institute of Nursing Research (NINR).
- Completed
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
NCT00366535 is a Phase 2 study that has completed, run by National Institute of Nursing Research (NINR). The registered enrollment target is 56 participants.
The verdict
NCT00366535, a Phase 2 study, has completed, sponsored by National Institute of Nursing Research (NINR).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
Study Summary
This study will examine the safety and effectiveness of the experimental drug, neurotropin, for preventing or easing pain associated with fibromyalgia. A disorder that primarily affects women, fibromyalgia causes widespread aching and stiffness in muscles. Neurotropin has been used in Japan for many years to treat various chronic painful conditions, including fibromyalgia. Women with fibromyalgia who have been treated unsuccessfully with standard therapy may be eligible for this study. Patients must have a history of widespread pain for more than half of the days in each of the three months before they enter the study. Candidates are screened with a medical history, physical examination, blood and urine tests, questionnaires and an electrocardiogram (EKG). Participants take their usual medications for fibromyalgia in addition to either neurotropin or a placebo (look-alike medicine with no active ingredient). At 6 weeks and 12 weeks into the study, they return to the NIH Clinical Center for evaluation of their sensitivity to pain and level of physical capability. After 12 weeks, study subjects "cross-over" their medication; that is, patients who took neurotropin for the first 12 weeks of the study take placebo for the next 12 weeks, and vice-versa. Again, after 6 and 12 weeks, patients return for evaluation. Participants have blood and urine tests six times during the study and complete questionnaires each week about their pain, symptoms, and activities.
Interventions
- DRUG Placebo
- DRUG Neurotropin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2006-08 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00366535
The ClinicalTrials.gov registry entry for NCT00366535 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Nursing Research (NINR), which has 46 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00366535 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00366535 about?
NCT00366535 is a clinical study titled "Neurotropin Treatment of Fibromyalgia". This study will examine the safety and effectiveness of the experimental drug, neurotropin, for preventing or easing pain associated with fibromyalgia. A disorder that primarily affects women, fibromyalgia causes widespread aching and stiffness in muscles. Neurotropin has been used in Japan for many...
What is the current status of trial NCT00366535?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2006-08. Estimated completion is 2015-12.
What interventions are being tested in trial NCT00366535?
The interventions under investigation include: Placebo (DRUG), Neurotropin (DRUG).
Who is sponsoring clinical trial NCT00366535?
This trial is sponsored by National Institute of Nursing Research (NINR), which has 46 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.