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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
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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
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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 
Overall Participants Analyzed 
[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
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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
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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
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  More Information
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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



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 ( Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. )
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