Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086684
Status:
TERMINATED
Last Update Posted:
2014-04-21
First Post:
2004-07-07
Brief Title:
Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
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
Status:
TERMINATED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim Analysis showed that study continuation was futile No safety concerns were raised during the trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
The purpose of this multi-center double-blind neither the patient nor the physician knows whether drug or placebo is being taken or at what dosage randomized patients are assigned different treatments based on chance parallel group trial is to evaluate the effectiveness and safety of two doses of pentosan polysulfate sodium 100 mg once a day and 100 mg three times a day versus placebo for 24 weeks for the relief of bladder pain or discomfort associated with interstitial cystitis The hypothesis of the study is that there is no treatment difference in the proportion of responders at study endpoint Week 24 Effectiveness will be assessed based on the reduction in the OLeary-Sant Interstitial Cystitis Symptom Index ICSI total score Safety assessments include vital signs laboratory tests adverse events and physical exams Patients will receive one of the following study treatments by mouth each day for 24 weeks pentosan polysulfate sodium 100 mg once a day group - one pentosan polysulfate sodium 100 mg capsule in the morning and one matching placebo capsule in the afternoon and evening pentosan polysulfate sodium 100 mg capsule three times a day group - one pentosan polysulfate sodium 100 mg capsule in the morning afternoon and evening placebo group - one placebo capsule in the morning afternoon and evening
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| C-2002-036 | OTHER | Johnson Johnson Pharmaceutical Research Development LLC | None |