Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis

This study has been terminated.
(Interim Analysis showed that study continuation was futile. No safety concerns were raised during the trial.)
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00086684
First received: July 7, 2004
Last updated: April 2, 2014
Last verified: April 2014
Results First Received: May 31, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Interstitial Cystitis
Interventions: Drug: Pentosan polysulfate sodium 100 mg
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three hundred and sixty-nine patients enrolled in this study. One patient did not take any study drug. Therefore, only 368 patients were included in the primary analysis dataset.

Reporting Groups
  Description
PLACEBO No text entered.
Pentosan Polysulfate Sodium (ELMIRON) 100MG QD One 100 mg pentosan polysulfate sodium capsule QD (once daily)
Pentosan Polysulfate Sodium (ELMIRON) 100MG TID One 100 mg pentosan polysulfate sodium capsule TID (three times a day)

Participant Flow:   Overall Study
    PLACEBO     Pentosan Polysulfate Sodium (ELMIRON) 100MG QD     Pentosan Polysulfate Sodium (ELMIRON) 100MG TID  
STARTED     118     129     122  
COMPLETED     63     74     69  
NOT COMPLETED     55     55     53  
Adverse Event                 12                 17                 14  
Lack of Efficacy                 6                 6                 5  
Lost to Follow-up                 15                 8                 10  
Protocol Violation                 8                 3                 0  
Withdrawal by Subject                 0                 4                 10  
NONCOMPLIANCE                 5                 7                 6  
STUDY TERMINATED BY SPONSOR                 0                 1                 0  
WITHDRAWAL OF CONSENT                 5                 7                 5  
Not specified                 4                 2                 3  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
PLACEBO No text entered.
Pentosan Polysulfate Sodium (ELMIRON) 100MG QD One 100 mg pentosan polysulfate sodium capsule QD (once daily)
Pentosan Polysulfate Sodium (ELMIRON) 100MG TID One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
Total Total of all reporting groups

Baseline Measures
    PLACEBO     Pentosan Polysulfate Sodium (ELMIRON) 100MG QD     Pentosan Polysulfate Sodium (ELMIRON) 100MG TID     Total  
Number of Participants  
[units: participants]
  118     129     122     369  
Age  
[units: participants]
       
<=18 years     1     1     0     2  
Between 18 and 65 years     103     108     109     320  
>=65 years     14     20     13     47  
Age  
[units: years]
Mean ± Standard Deviation
  44.6  ± 14.58     45.6  ± 15.68     42.7  ± 15.71     44.3  ± 15.35  
Gender  
[units: participants]
       
Female     101     119     113     333  
Male     17     10     9     36  
AgeCategorical  
[units: participants]
       
<18 YEARS     0     0     0     0  
18-<64 YEARS     104     109     109     322  
65-<74 YEARS     10     17     11     38  
>=75 YEARS     4     3     2     9  
Baseline BMI  
[units: kg/cm2]
Mean ± Standard Deviation
  27  ± 6.50     26.8  ± 9.42     27.1  ± 11.02     26.9  ± 9.18  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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   [ Time Frame: Baseline to Week 24 ]

2.  Secondary:   Number of Responders Defined as Having at Least a Four Point Reduction in the O’Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint   [ Time Frame: Baseline to Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: SENIOR DIRECTOR CLINICAL LEADER
Organization: Janssen R&D US
phone: 1 609 730-4529


No publications provided


Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00086684     History of Changes
Obsolete Identifiers: NCT00399139
Other Study ID Numbers: CR004576, C-2002-036
Study First Received: July 7, 2004
Results First Received: May 31, 2012
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration