Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-28

Study Completion Date

2008-02-28

Brief Summary

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A double-blind, placebo-controlled study to evaluate changes in pain, urgency and urinary frequency following administration of URG101 compared to placebo.

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Detailed Description

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Conditions

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Painful Bladder Syndrome Interstitial Cystitis Bladder Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Crossover

Placebo Treatment on Visit 1 followed by URG101 Treatment on Visit 2

Group Type OTHER

URG101

Intervention Type DRUG

Bladder instillation of URG101 or Placebo in random order on treatment 1 and treatment 2 followed by an open-label URG101 on treatment 3 within the same week.

Placebo

Intervention Type DRUG

Liquid formulation without active URG101 drug components

Crossover 2

URG101 Treatment on Visit 1 followed by Placebo Treatment on Visit 2

Group Type OTHER

URG101

Intervention Type DRUG

Bladder instillation of URG101 or Placebo in random order on treatment 1 and treatment 2 followed by an open-label URG101 on treatment 3 within the same week.

Placebo

Intervention Type DRUG

Liquid formulation without active URG101 drug components

Interventions

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URG101

Bladder instillation of URG101 or Placebo in random order on treatment 1 and treatment 2 followed by an open-label URG101 on treatment 3 within the same week.

Intervention Type DRUG

Placebo

Liquid formulation without active URG101 drug components

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* male and female subjects \>= 18 years of age
* moderate to severe symptoms of PBS/IC
* minimum pain/urgency/frequency scores
* female subjects on hormone therapy must be on stable dose for \>= 3 months

Exclusion Criteria

* positive pregnancy test or pregnant or lactating
* narcotics or medical marijuana within 3 months
* use of any investigational drug or device within 30 days
* bacterial cystitis within 30 days

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No