NCT00517868

Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis

URG101 Pharmacodynamic and Safety Study: A Randomized, Double-blind, Placebo-controlled, Multi-center Cross-over Study to Investigate the Pharmacodynamic Profile of URG101 in Subjects With Pelvic Pain of Bladder Origin.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Urigen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Painful Bladder Syndrome
• Interstitial Cystitis
• Bladder Pain Syndrome

Interventions

Type	Name	Description
DRUG	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.
DRUG	Placebo	Liquid formulation without active URG101 drug components

Timeline

• Start date: 2007-08-28
• Primary completion: 2008-02-28
• Completion: 2008-02-28
• First posted: 2007-08-17
• Last updated: 2024-08-23
• Results posted: 2024-08-23

Locations

6 sites across 1 country: United States