Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (132% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00004316 record still lists
NCT00004316 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (132% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00004316 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00004316's enrollment target sits among peer trials
139 418th of 2000 higher than 1,583 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05645380 · 139 participants · Phase 2
Neoadjuvant TIL- and Response-Adapted Chemoimmunotherapy for TNBC
- NCT06239272 · 139 participants · Phase 1
NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)
- NCT06252220 · 139 participants · Phase 1
First in Human Study in Subjects With Obesity, But Otherwise Healthy
- NCT06537128 · 139 participants · NA
Internet-delivered Cognitive-Behavioral Therapy for Adolescents With Autism and Anxiety
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia