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Beta-3 Adrenergic Agonist

Evaluation of the Efficacy and Safety of Solabegron Tablets for Treatment of Overactive Bladder in Adult Women

Phase 2
Waitlist Available
Research Sponsored by Velicept Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Adult female subjects 18 to 80 years of age, with a ≥ 6-month history of symptoms of overactive bladder including: frequency, urgency, and urgency urinary incontinence. Subjects must provide written informed consent and either be of non-childbearing potential or of childbearing potential meeting specific criteria (e.g., negative pregnancy test, sexual inactivity, acceptable methods of birth control, and use of hormonal contraceptives).
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prior to randomization (baseline) and at weeks 4, 8, and 12

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 immediate release low dose or high dose tablets, compared to matched placebo, administered twice daily for 12 weeks to adult female subjects with overactive bladder symptoms (frequency, urgency, and predominantly urgency incontinence) for at least 6 months.

Eligible Conditions
  • Overactive Bladder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prior to randomization (baseline) and at weeks 4, 8, and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to randomization (baseline) and at weeks 4, 8, and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline in mean number of micturitions per 24h at Week 12
Secondary study objectives
Micturitions (1)
Micturitions (2)
Micturitions (3)
+15 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Solabegron immediate release tablets low doseExperimental Treatment1 Intervention
Group II: Solabegron immediate release tablets high doseExperimental Treatment1 Intervention
Group III: Placebo ComparatorPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Solabegron
Not yet FDA approved
Solabegron
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Velicept Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
1,437 Total Patients Enrolled
~56 spots leftby Dec 2025
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