Overactive BladderPhase 2NCT01294982

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

A Phase 2 study testing AOBO-001 in people with Overactive Bladder, run by American Oriental Bioengineering, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Overactive Bladder
What is being tested?: AOBO-001
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 66 participants
Where: 5 sitesUnited States
Study dates: Dec 2010to Nov 2011
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient is male or female aged 18 years or older and provides written informed consent;
Patient has had symptoms of OAB, including urinary frequency, urgency or urge incontinence, for at least 3 months prior to the screening visit;
Patient is compliant with completing 3 consecutive days of the urinary diary each week and at least 85% compliant with taking placebo capsules during the 2-week placebo run-in period;
Patient experiences an average micturition frequency of ≥8 times per a 24-hour period based on the 24-hour average of 3 consecutive days of urinary diary data during the last week of the 2-week placebo run-in period;
Patient has had at least 4 episodes of incontinence over a 3 consecutive day urinary diary period during the 2-week placebo run-in period; and
Patient has had at least 4 episodes of urgency (PPIUS Grade 3 or 4) with or without incontinence over a 3 consecutive day urinary diary period during the 2-week placebo run-in period.

Who cannot join

Patients with known allergy to plants of Sapindaceae family, including maple syrup, litchi (Litchi chinensis), rambutan (Nephelium lappaceum), longan (Euphoria longana), ackee (Blighia sapida) and Spanish Lemon (Melicoccus bijugus).
Pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and practicing an unreliable method of birth control or will be lactating during the study. Reliable contraceptive methods are intra-uterine devices, double-barrier method (condom with spermicide), contraceptive pills of combination type, hormonal implants and injectable or patch contraceptives;
Clinically significant outflow obstruction (at the discretion of the investigator);
Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor, as determined by the investigator;
Patient with indwelling catheters or practicing intermittent self-catheterization;
Evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs;

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Non-drug OAB treatment such as bladder-training, biofeedback and pelvic floor exercises are permissible if established at least 4 weeks prior to study start and intended to be continued throughout the study; electrostimulation therapy is not permissible at any time;
Use of drugs intended to treat urinary incontinence, such as darifenacin (Enablex), fesoterodine (Toviaz), oxybutynin (Ditropan, Ditropan XL, Oxytrol), solifenacin (Vesicare), tolterodine (Detrol, Detrol LA), and trospium (Sanctura, Sanctura XR);
Any clinically significant condition, which in the opinion of the investigator makes the patient unsuitable for the trial, including without limitation, major cardiovascular or cerebrovascular event (e.g., myocardial infarction, stroke, unstable angina, transient ischemic attacks) within the past year, major neurological disorders (e.g., paralysis or neuropathies, multiple sclerosis), major psychiatric diseases (e.g., major depression, generalized anxiety, psychosis), unstable or poorly controlled chronic diseases (e.g., uncontrolled moderate to severe hypertension or poorly controlled diabetes mellitus), and moderate to severe renal or hepatic disease;
Participation in any clinical trial within 30 days prior to randomization;
Women who suffer from undiagnosed vaginal bleeding;
Employees of AOBO, third parties associated with the study, or the study site; and
Patient who did not complete the urinary diary (3 consecutive days of valid urinary diary data each week) and did not take placebo run-in study medication (at least 85% compliance) according to the instructions during the placebo run-in period.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Regional Clinical Research, Inc
Endwell, New York, 13760
Myron I. Murdock M.D. LLC
Greenbelt, Maryland, 20770
Coastal Clinical Research
Mobile, Alabama, 36608
Heartland Research Associate, LLC
Newton, Kansas, 67114
Palm Beach Research Center
West Palm Beach, Florida, 33409

Other trials in United States

About this study

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

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.

Read the detailed 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.

Conditions: Overactive Bladder
Being tested: AOBO-001, Placebo
Keywords: OAB, Over Active Bladder, overactive bladder, Urinary Urge Incontinence, Urinary Incontinence
Medical subject headings: Urinary Bladder, Overactive, Urinary Incontinence, Urge, Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AOBO-001Drug
AOBO-001 400 mg Oral Capsules (1.6 g dose) twice daily
AOBO-001Drug
AOBO-001 400 mg Oral Capsules (3.2 g dose) twice daily
PlaceboDrug
Placebo Oral Capsules twice daily

Study groups in NCT01294982
Study group	Role	What they receive
1.6 g AOBO-001 Group	Experimental	AOBO-001 400 mg Oral Capsules Receives: Drug: AOBO-001
3.2 g AOBO-001 Group	Experimental	AOBO-001 400 mg Oral Capsules Receives: Drug: AOBO-001
Placebo	Placebo comparator	Matching Placebo Capsules Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in average number of micturitions per 24 hours from 3-day urinary diaries compared to baseline
Change in the average number of micturitions per 24 hours from the 3-day diaries from baseline to endpoint of the 12 week double-blind treatment period.
Measured: Endpoint (up to 12 weeks of double-blind treatment)
Change in average number of urge incontinence episodes per 24 hours from 3-day urinary diaries compared to baseline
Change in average number of urge urinary incontinence episodes per 24 hours from the 3-day diaries from baseline to endpoint of the 12 week double-blind treatment period.
Measured: Endpoint (up to 12 weeks of double-blind treatment)

Secondary outcomes (6)

Change in volume voided per micturition compared to baseline
Volume voided per micturition over 24 hours.
Measured: Endpoint (up to 12 weeks of double-blind treatment)
Change in intensity of urgency episodes compared to baseline
Intensity of urgency episodes, PPIUS grade 3+4, intensity of urgency episodes, PPIUS grades 0-4, and maximum urgency intensity at void episodes (PPIUS grades 0-4) per 24 hours.
Measured: Endpoint (up to 12 weeks of double-blind treatment)
Change in daytime and sleeptime micturitions compared to baseline
Number of daytime and sleeptime (nocturia) micturition episodes per 24 hours.
Measured: Endpoint (up to 12 weeks of double-blind treatment)
Change in weekly urge incontinence episodes compared to baseline
Number of urge urinary incontinence episodes per week.
Measured: Endpoint (up to 12 weeks of double-blind treatment)
Change in PPBC score compared to baseline
Patient Perception of Bladder Condition (PPBC) score.
Measured: Endpoint (up to 12 weeks of double-blind treatment)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Treatment-emergent adverse events including subject reporting, clinical observations, and clinically significant abnormal findings as measured by bladder scan, vital signs, 12-lead ECGs, complete or brief physical examinations and clinical laboratory safety tests.
Measured: During double-blind treatment phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010Nov 2011

First posted14 Feb 2011 (estimated)
Study startDec 2010
Primary completionNov 2011
Study completionNov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Overactive BladderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01294982
Sponsor's protocol ID: 20100011031
Status last verified: Jan 2013
First submitted: 4 Jan 2011
Last updated: 23 Jan 2013
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Overactive Bladder trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01294982
Acronym / sponsor ID: 20100011031
Conditions: Overactive Bladder
Keywords: OAB, Over Active Bladder, overactive bladder, Urinary Urge Incontinence, Urinary Incontinence
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: American Oriental Bioengineering, Inc.Industry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 14 Feb 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
1.6 g AOBO-001 Group	Experimental	Drug: AOBO-001AOBO-001 400 mg Oral Capsules
3.2 g AOBO-001 Group	Experimental	Drug: AOBO-001AOBO-001 400 mg Oral Capsules
Placebo	Placebo comparator	Drug: PlaceboMatching Placebo Capsules

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patient is male or female aged 18 years or older and provides written informed consent;
Patient has had symptoms of OAB, including urinary frequency, urgency or urge incontinence, for at least 3 months prior to the screening visit;
Patient is compliant with completing 3 consecutive days of the urinary diary each week and at least 85% compliant with taking placebo capsules during the 2-week placebo run-in period;
Patient experiences an average micturition frequency of ≥8 times per a 24-hour period based on the 24-hour average of 3 consecutive days of urinary diary data during the last week of the 2-week placebo run-in period;
Patient has had at least 4 episodes of incontinence over a 3 consecutive day urinary diary period during the 2-week placebo run-in period; and

Key exclusion criteria (13 listed)

Patients with known allergy to plants of Sapindaceae family, including maple syrup, litchi (Litchi chinensis), rambutan (Nephelium lappaceum), longan (Euphoria longana), ackee (Blighia sapida) and Spanish Lemon (Melicoccus bijugus).
Pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and practicing an unreliable method of birth control or will be lactating during the study. Reliable contraceptive methods are intra-uterine devices, double-barrier method (condom with spermicide), contraceptive pills of combination type, hormonal implants and injectable or patch contraceptives;
Clinically significant outflow obstruction (at the discretion of the investigator);
Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor, as determined by the investigator;
Patient with indwelling catheters or practicing intermittent self-catheterization;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AOBO-001AOBO-001 400 mg Oral Capsules (1.6 g dose) twice daily	Drug	1.6 g AOBO-001 Group
AOBO-001AOBO-001 400 mg Oral Capsules (3.2 g dose) twice daily	Drug	3.2 g AOBO-001 Group
PlaceboPlacebo Oral Capsules twice daily	Drug	Placebo

Primary outcome

Change in average number of micturitions per 24 hours from 3-day urinary diaries compared to baseline
Time frame: Endpoint (up to 12 weeks of double-blind treatment)
Change in the average number of micturitions per 24 hours from the 3-day diaries from baseline to endpoint of the 12 week double-blind treatment period.
Change in average number of urge incontinence episodes per 24 hours from 3-day urinary diaries compared to baseline
Time frame: Endpoint (up to 12 weeks of double-blind treatment)
Change in average number of urge urinary incontinence episodes per 24 hours from the 3-day diaries from baseline to endpoint of the 12 week double-blind treatment period.

6 secondary outcomes

Change in volume voided per micturition compared to baseline
Time frame: Endpoint (up to 12 weeks of double-blind treatment)
Change in intensity of urgency episodes compared to baseline
Time frame: Endpoint (up to 12 weeks of double-blind treatment)
Change in daytime and sleeptime micturitions compared to baseline
Time frame: Endpoint (up to 12 weeks of double-blind treatment)
Change in weekly urge incontinence episodes compared to baseline
Time frame: Endpoint (up to 12 weeks of double-blind treatment)
Change in PPBC score compared to baseline
Time frame: Endpoint (up to 12 weeks of double-blind treatment)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: During double-blind treatment phase

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.

Related trials for Overactive Bladder

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tom Du, MD, PhD study director

American Oriental Bioengineering, Inc.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AOBO-001 in people with Overactive Bladder, run by American Oriental Bioengineering, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in average number of micturitions per 24 hours from 3-day urinary diaries compared to baseline (time frame: Endpoint (up to 12 weeks of double-blind treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01294982.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2013.