Who is sponsoring NCT00086684?

NCT00086684 is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

What condition does NCT00086684 study?

NCT00086684 studies Interstitial Cystitis.

What drugs are being tested in NCT00086684?

Interventions: Pentosan polysulfate sodium 100 mg, Placebo, Pentosan polysulfate sodium 100 mg.

What is the status of NCT00086684?

NCT00086684 is currently TERMINATED.

Last reviewed 2014-04-02 · How we verify

Randomized, Double-Blind, Placebo-Controlled, Parallel Group Evaluation of the Efficacy and Tolerability of Two Different Doses of ELMIRON for the Treatment of Interstitial Cystitis

NCT00086684 Phase 4 TERMINATED Results posted

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.

Details

Lead sponsor	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Phase	Phase 4
Status	TERMINATED
Enrolment	369
Start date	2003-09
Completion	2011-06

Conditions

Interstitial Cystitis

Interventions

Pentosan polysulfate sodium 100 mg
Placebo
Pentosan polysulfate sodium 100 mg

Primary outcomes

Number of Responders Defined as Having at Least a 30% Reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint — Baseline to Week 24
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 indicates a better condition.

Countries

United States, Canada