Study of AOBO-001 for Overactive Bladder With Urge Urinary Incontinence and Frequency

Overactive Bladder Clinical Trial

Official title: Phase II, Randomized, Double-blind, Placebo-controlled Trial of the AOBO-001 for the Treatment of Overactive Bladder With Symptoms of Urge Urinary Incontinence and Frequency

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability, and effectiveness of the study product, AOBO-001, when taken by adults with symptoms of overactive bladder. AOBO-001, is experimental, which means that the U. S. Food and Drug Administration (FDA) has not yet approved it for use. AOBO-001 has been approved in China as a prescription drug product to treat bedwetting in children. AOBO-001 is also approved in Hong Kong as a dietary supplement to improve quality of life for people with urinary incontinence. AOBO-001 is a botanical (from a plant) product. It is prepared from the seeds of Xanthoceras sorbifolia bunge plant, which is a flowering tree grown in Northern China. Approximately 60 subjects who are 18 years of age and older are expected to participate in this study at up to 8 investigational sites. Each subject will complete 6 visits to the study site over a 14-week period. Subjects will consume 8 capsules of the assigned test product twice daily (that is, 16 capsules daily). Capsules will be taken with at least 6 ounces of water approximately 30 minutes before breakfast and 30 minutes before dinner. If a subject qualifies, he/she will be randomly (by chance) assigned to one of three study treatment groups. Subjects in one group will consume capsules containing a daily dose of 3.2 grams of AOBO-001; a second group will consume capsules containing a daily dose of 6.4 grams of AOBO-001; and a third group will consume capsules containing a placebo (no active ingredients). Subjects will have a 2 in 3 chance of being assigned to an active study treatment group. Neither the subject nor the study doctor will know to which study treatment group the subject has been assigned, but this information is available in case of a medical emergency. There will be a time during the study dosing schedule when all subjects will consume capsules containing a placebo (no active ingredients). Subjects will not be told when they are receiving the placebo.

Clinical Trial Description

This randomized, double-blind, placebo-controlled Phase 2 clinical trial will evaluate the safety and efficacy of AOBO-001 in adults with overactive bladder. The primary objective of this study is to evaluate the efficacy of AOBO 001 compared with placebo on the basis of the change from baseline in average number of micturition episodes per 24 hours from the 3-day diaries and average number of urge urinary incontinence episodes per 24 hours from the 3 day diaries during the double-blind treatment period in adult patients with OAB. Secondary efficacy objectives are to evaluate the efficacy of AOBO-001 compared with placebo on the basis of the number and severity of urgency episodes by using the Patient's Perception of Intensity of Urgency Scale (PPIUS), nocturia episodes, volume voided per micturition, and Patient Perception of Bladder Condition (PPBC) global assessment measure. An additional secondary objective is to evaluate the safety and tolerability of AOBO-001 compared with placebo.

Eligible patients will be randomized in equal proportions to double-blind treatment with AOBO 001 1.6 g twice daily (3.2 g daily), AOBO-001 3.2 g twice daily (6.4 g daily) or placebo capsules twice daily.

Efficacy assessments include urinary diary assessments, including the number of micturitions (daytime, nighttime), number of urge incontinence episodes, number/grading of urgency episodes (Patient's Perception of Intensity of Urgency Scale or PPIUS), and volume of voided urine; and Patient Perception of Bladder Condition (PPBC) questionnaire. Safety assessments include post-void residual urine volume measured by bladder scan; vital signs, 12-lead ECGs, complete or brief physical examinations, clinical laboratory safety tests, and treatment-emergent adverse events. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Incontinence
• Urinary Incontinence, Urge

• NCT number: NCT01294982
• Study type: Interventional
• Source: American Oriental Bioengineering, Inc.
• Status: Completed
• Phase: Phase 2
• Start date: December 2010
• Completion date: November 2011