NCT03594058

A Study to Evaluate Once Daily Low Dose and High Dose Solabegron or Placebo Given for 12 Weeks to Treat Women With Symptoms of Overactive Bladder: Sudden Urge to Urinate, Frequent Urination Associated With Wetting Episodes (VEL-2001)

A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Oral Solabegron Modified Release Tablets in the Treatment of Overactive Bladder (OAB) in Adult Female Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,413 (actual)
• Sponsor: Velicept Therapeutics, Inc. · Industry
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, and tolerability of solabegron modified release low dose or high dose tablets, compared to matched placebo, administered once daily for 12 weeks to adult female subjects with overactive bladder symptoms (frequency, urgency, and predominantly urgency incontinence) for at least 6 months.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DRUG	Solabegron modified release tablets, low dose	Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks.
DRUG	Solabegron modified release tablets, high dose	Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks.
DRUG	Matching Placebo	Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks.

Timeline

• Start date: 2018-07-09
• Primary completion: 2019-04-29
• Completion: 2019-05-02
• First posted: 2018-07-20
• Last updated: 2020-03-02

Locations

77 sites across 1 country: United States

Regulatory

• FDA-regulated drug study