A Pilot Clinical Investigation of the Efficacy and Safety of Uracyst® Versus Placebo in Patients With Interstitial Cystitis/Painful Bladder Syndrome.

Watson Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Interstitial Cystitis

Treatments: Device: Uracyst; Device: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00527917

UR07001

Details and patient eligibility

About

This is a pilot clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive either an active product (Uracyst®) or placebo intravesically via a bladder catheter weekly for 6 weeks, followed by 6 weeks of follow-up period.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are female of male patient 18 years or older
• Have been previously diagnosed with IC/PBS.
• Are willing to provide informed consent
• Available for the duration of the study including treatment and follow-up (12 weeks)

Exclusion criteria

• Pregnant or lactating female.
• Are currently or have previously received investigational drugs within thirty (30) days of screening.
• Previous therapy for IC/PBS
• Have any medical condition/disease that could interfere with patient compliance or interfere with interpretation of the study results.
• Are unable or unwilling to comply with protocol requirements
• Are unable to read, understand, and provide written informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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65 participants in 2 patient groups, including a placebo group

Uracyst

Experimental group

Description:

Sodium chondroitin sulfate

Treatment:

Device: Uracyst

Placebo

Placebo Comparator group

Description:

placebo

Treatment:

Device: placebo