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NCT00004316 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis
A Phase 1 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 1
- Development phase
- 139
- Enrollment target
NCT00004316 is a Phase 1 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 139 participants.
The verdict
NCT00004316, a Phase 1 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 139 participants
- Enrollment target
Study Summary
OBJECTIVES: I. Estimate the optimal safe dose of intravesical capsaicin in patients with interstitial cystitis. II. Evaluate the efficacy of 0.025% topical capsaicin in relieving chronic burning pain in patients with vulvar vestibulitis. III. Evaluate the effect of capsaicin on type C nerve fibers in bladder mucosa and vulvar skin. IV. Evaluate the effect of C fiber depletion on urinary levels of histamine and prostaglandin.
Interventions
- DRUG Placebo
- DRUG capsaicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 1995-06 |
| Est. Completion | 2007-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00004316
The ClinicalTrials.gov registry entry for NCT00004316 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 139 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00004316 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00004316 about?
NCT00004316 is a clinical study titled "Phase I/II Randomized, Placebo-Controlled Study of Capsaicin for Interstitial Cystitis and Vulvar Vestibulitis". OBJECTIVES: I. Estimate the optimal safe dose of intravesical capsaicin in patients with interstitial cystitis. II. Evaluate the efficacy of 0.025% topical capsaicin in relieving chronic burning pain in patients with vulvar vestibulitis. III. Evaluate the effect of capsaicin on type C nerve fibers...
What is the current status of trial NCT00004316?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 139 participants. The study started on 1995-06. Estimated completion is 2007-08.
What interventions are being tested in trial NCT00004316?
The interventions under investigation include: Placebo (DRUG), capsaicin (DRUG).
Who is sponsoring clinical trial NCT00004316?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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