Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis

Urigen

Status and phase: Terminated; Phase 2

Conditions: Interstitial Cystitis; Painful Bladder Syndrome; Bladder Pain Syndrome

Treatments: Drug: Placebo; Drug: URG101

Study type: Interventional

Funder types: Industry

Identifiers

NCT00517868

URG101-104

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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28 participants in 2 patient groups

Crossover

Other group

Description:

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

Treatment:

Drug: URG101

Drug: Placebo

Crossover 2

Other group

Description:

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

Treatment:

Drug: URG101

Drug: Placebo