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: January 23, 2013

Last verified: January 2013

History of Changes

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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Baseline Characteristics

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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

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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 ]

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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 ]

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Serious Adverse Events

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Other Adverse Events

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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.

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.

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:	January 23, 2013
Health Authority:	United States: Food and Drug Administration

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