Study of AOBO-001 for Overactive Bladder With Urge Urinary Incontinence and Frequency
| Status: | Archived |
|---|---|
| Conditions: | Overactive Bladder, Urology |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | December 2010 |
| End Date: | December 2011 |
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
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.
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.
We found this trial at
1
site
1897 Palm Beach Lakes Boulevard
West Palm Beach, Florida 33409
West Palm Beach, Florida 33409
561-689-0606
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