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

Phase 2

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: Matching Placebo; Drug: Solabegron immediate release tablets, low dose; Drug: Solabegron immediate release tablets, high dose

• Registration Number: NCT03475706
• Lead Sponsor: Velicept Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-19
• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-03-16
• Study First Posted: 2018-03-23
• Status Verified: 2019-01
• Primary Completion: 2019-01-24
• Study Completion: 2019-01-30
• Disposition First Submitted: 2020-02-27
• Disposition First Submitted QC: 2020-02-27
• Last Update Submitted: 2020-02-27
• Disposition First Posted: 2020-03-02
• Last Update Posted: 2020-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 438

Inclusion Criteria

• 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).

Exclusion Criteria

• Subjects must have no history of pelvic or bladder disease, e.g., Grade 3/4 uterine prolapse, urogenital malignancy within the past 2 years, surgery for stress incontinence or pelvic prolapse repair within the past 6 months, or bladder injections with botulinum toxin at any time.
• Diabetes insipidus or poorly controlled Type 1 or Type 2 diabetes mellitus
• Cardiac conditions: prior cardiovascular events or procedures within 6 months of screening; congestive heart failure; abnormal ECG findings, including ECG QT correction interval (QTc) > 470 msec at the Screening Visit; systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥100mmHg, or heart rate > 100 beats per minute.
• Abnormal tests of liver function
• History of prior infection due to HIV or hepatitis B or hepatitis C virus
• Allergy or hypersensitivity to solabegron or mirabegron
• Women of childbearing potential: breastfeeding, pregnant, or actively trying to become pregnant
• Participation in a trial of an investigational or marketed drug ≤ 30 days prior to the Screening Visit or in any clinical trial of an investigational drug that may affect urinary function within 3 months prior to Screening Visit.
• Inability to read, understand, or complete study-related materials.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator	Matching Placebo	-
Solabegron immediate release tablets low dose	Solabegron immediate release tablets, low dose	-
Solabegron immediate release tablets high dose	Solabegron immediate release tablets, high dose	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline in mean number of micturitions per 24h at Week 12	Micturitions will be assessed prior to randomization and at Week 12 (Visit 6).	Micturition events will be recorded by subjects in an eDiary using a smartphone device during 3-day diary periods prior to randomization and at 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Urinary Incontinence (5)	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12	Change from Baseline in total urinary incontinence episodes (urgency and non-urgency) per 24h.
Micturitions (1)	Prior to Randomization (Baseline) and at Weeks 4 and 8	Change from Baseline in mean number of micturitions per 24h.
Micturitions (4)	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12	Change from Baseline in mean number of nocturnal voids per 24h.
Urine Void Volume (1)	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12	Change from Baseline in average void volume over 24h.
Urine Void Volume (2)	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12	Percentage change from Baseline in average void volume over 24h.
Urine Void Volume (3)	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12	Change from Baseline in maximum individual void volume over 24h.
Urine Void Volume (4)	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12	Percentage change from Baseline in maximum individual void volume over 24h.
Urgency (1)	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12	Proportion of subjects with urges with a mean grade of 3 or 4 per 24h.
Urgency (2)	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12	Change from Baseline in urgency assessments per 24h associated with micturitions and incontinence.
Patient Reported Outcomes (1)	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12	Patient Perception of Bladder Condition
Patient Reported Outcomes (2)	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12	Change from Baseline in Symptom Bother Score (OAB-q short form).
Urinary Incontinence (1)	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12	Change from Baseline in mean number of urgency urinary incontinence episodes per 24h.
Micturitions (3)	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12	Percentage of subjects with \<8 micturitions per 24h.
Urinary Incontinence (4)	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12	Proportion of subjects with no episodes of urinary incontinence (urgency or non-urgency) per 24h.
Urinary Incontinence (2)	Prior to Randomization (Baseline) and at Weeks 4 and 8	Percentage change from Baseline in mean number of urgency urinary incontinence episodes per 24h.
Micturitions (2)	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12	Percentage change from Baseline in mean number of micturitions per 24h.
Urinary Incontinence (3)	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12	Proportion of subjects with no episodes of urgency urinary incontinence per 24h.
Patient Reported Outcomes (3)	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12	Change from Baseline in health-related quality of life (OAB-q short form).

Trial Locations

Locations (80)

Velicept Investigative Site - Birmingham; 🇺🇸 Birmingham, Alabama, United States

Velicept Investigative Site - Gulf Shores; 🇺🇸 Gulf Shores, Alabama, United States

Velicept Investigative Site - Mobile; 🇺🇸 Mobile, Alabama, United States

Velicept Investigative Site - Tempe; 🇺🇸 Tempe, Arizona, United States

Velicept Investigative Site - Tucson; 🇺🇸 Tucson, Arizona, United States

Velicept Investigative Site - Little Rock; 🇺🇸 Little Rock, Arkansas, United States

Velicept Investigative Site - Anaheim; 🇺🇸 Anaheim, California, United States

Velicept Investigative Site - Arcadia; 🇺🇸 Arcadia, California, United States

Velicept Investigative Site - Canoga Park; 🇺🇸 Canoga Park, California, United States

Velicept Investigative Site - Huntington Beach; 🇺🇸 Huntington Beach, California, United States

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