Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis - Full Text View

Sponsor:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00086684

Purpose

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.

Condition	Intervention	Phase
Interstitial Cystitis	Drug: Pentosan polysulfate sodium 100 mg Drug: Placebo	Phase IV

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
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

Resource links provided by NLM:

MedlinePlus related topics: Interstitial Cystitis

Drug Information available for: Pentosan sulfuric polyester Elmiron Hoe-bay 946

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

The proportion of patients with at least a 30% reduction in the patient-completed O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients with at least a 4-point reduction in ICSI [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
Proportion of patients with >= 50% improvement in Patient Overall Rating of Improvement of Symptoms (PORIS) [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]

Enrollment:	369
Study Start Date:	July 2003
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pentosan polysulfate sodium 100 mg once a day One 100 mg pentosan polysulfate sodium capsule in the morning and 1 matching placebo capsule in the afternoon and evening for 24 weeks	Drug: Pentosan polysulfate sodium 100 mg One 100 mg pentosan polysulfate sodium capsule in the morning, and 1 matching placebo capsule in the afternoon and evening for 24 weeks
Experimental: Pentosan polysulfate sodium 100 mg three times a day One 100 mg pentosan polysulfate sodium capsule 3 times a day (morning afternoon and evening) for 24 weeks	Drug: Pentosan polysulfate sodium 100 mg One 100 mg pentosan polysulfate sodium capsule 3 times a day (morning, afternoon, and evening) for 24 weeks
Placebo Comparator: Placebo Placebo One placebo capsule 3 times a day (morning afternoon and evening) for 24 weeks	Drug: Placebo One placebo capsule 3 times a day (morning, afternoon and evening) for 24 weeks

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 O'Leary-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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Must have a total score of 8 or greater on the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) and a score of > 0 on each of the 4 questions on the ICSI
must have experienced bladder pain, urinary urgency and urinary frequency, each not related to a urinary tract infection, for at least 6 months prior to entry into the study
must have averaged >= 10 voids per day (>=30 voids over 3 consecutive days) and averaged >= 1 void at night
urine culture showing no evidence of urinary tract infection
urine cytology showing no evidence of neoplastic cells

Exclusion Criteria:

Scheduled for or use of intravesical therapy (eg, bladder distention, dimethyl sulfoxide) during or within 4 weeks prior to the study
patients who have had cytoscopic evaluation within 4 weeks prior to the study
patients who are currently (within last month) receiving other medications that may affect symptoms of interstitial cystitis (ie, antidepressants, antihistamines, antispasmodics, anticholinergics)
patients who are chronic users of Schedule II narcotics or who are using any scheduled narcotics at the time of study entry
patients taking coumadin, anticoagulants, heparin, or thrombolytic agents such as tissue plasminogen activator and streptokinase

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00086684

Show 66 Study Locations

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

Additional Information:

To learn how to participate in this trial please click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	SR DIR CLINICAL LEADER, 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
Last Updated:	December 5, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Interstitial Cystitis
Urinary Bladder Pain

Additional relevant MeSH terms:

Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Pentosan Sulfuric Polyester

Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012