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NCT00086684 · ClinicalTrials.gov registry record · Phase 4
Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis
A Phase 4 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Terminated
- Registry status
- Phase 4
- Development phase
- 369
- Enrollment target
NCT00086684: Clinical Trial Phase 4 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
NCT00086684 is a Phase 4 study that was terminated before completion, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 369 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00086684, a Phase 4 study, was terminated before completion, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 369 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and effectiveness of pentosan polysulfate sodium 100 mg once a day, pentosan polysulfate sodium 100 mg three times a day, and placebo for 24 weeks for the relief of bladder pain or discomfort associated with interstitial cystitis.
Primary Outcome
The ICSI is a four-item self-administered instrument developed for the evaluation and management of patients with interstitial cystitis. The index measures the presence and extent of symptoms including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI is on a 0-5 scale, where each answer is given a specific rating. The sum of the individual question ratings is the score for the ICSI. The range of the test is a score of 0 to 20. A lower score
Interventions
- DRUG Placebo
- DRUG Pentosan polysulfate sodium 100 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 369 participants |
| Start Date | 2003-09 |
| Est. Completion | 2011-06 |
| Phase | Phase 4 |
Why NCT00086684 stopped before completion
NCT00086684 is an interventional study that assigns participants to a tested intervention. The registered 369 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (29% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00086684 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00086684 about?
NCT00086684 is a clinical study titled "Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis". The purpose of this study is to evaluate the safety and effectiveness of pentosan polysulfate sodium 100 mg once a day, pentosan polysulfate sodium 100 mg three times a day, and placebo for 24 weeks for the relief of bladder pain or discomfort associated with interstitial cystitis.
What is the current status of trial NCT00086684?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 369 participants. The study started on 2003-09. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00086684?
The interventions under investigation include: Placebo (DRUG), Pentosan polysulfate sodium 100 mg (DRUG).
Who is sponsoring clinical trial NCT00086684?
This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00086684's enrollment target sits among peer trials
369 224th of 2000 higher than 1,777 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
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