ObesityPhase 4NCT00932022

Trospium Chloride XR in Obese Female Patients With Overactive Bladder

A Phase 4 study testing Trospium Chloride, Extended Release (XR) in people with Obesity and Overactive Bladder, run by Allergan at 1 site 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 to 75 years, women only
Conditions the study is for: Obesity, Overactive Bladder, Incontinence
What is being tested?: Trospium Chloride, Extended Release (XR)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 127 participants
Where: 1 siteUnited States
Study dates: Jul 2009to Dec 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

OAB syndrome with Urgency, Urinary frequency and Urgency urinary incontinence
Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the screening visit).
Obese

Who cannot join

Chronic kidney failure
Abdominal bypass surgery for obesity
Moderate or severe memory impairment
Uncontrolled narrow angle glaucoma
Uncontrolled systemic disease
Concurrent dementia drugs: Aricept (donepezil), Namenda (memantine), Cognex (tacrine), Exelon (rivastigmine), Razadyne (galantamine), or similar drugs for dementia

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
La Mesa, California

Other trials in United States

About this study

This study evaluated the effectiveness of trospium chloride extended release (XR) in obese female patients with overactive bladder (OAB). Patients received either placebo and trospium chloride XR or placebo only. The study assessed the change from baseline in urinary frequency, urgency, and incontinence for trospium chloride XR versus a placebo-pill. The study was 14 weeks in duration.

Conditions: Obesity, Overactive Bladder, Incontinence
Being tested: Trospium Chloride, Extended Release (XR), placebo
Medical subject headings: Obesity, Urinary Bladder, Overactive

What participants receive

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

Trospium Chloride, Extended Release (XR)Drug
Also called Sanctura XR™ 60 mg
Trospium chloride extended release 60 mg capsule taken orally once daily for 12 weeks.
placeboOther
Placebo capsule taken orally once daily for either 2 weeks or 14 weeks.

Study groups in NCT00932022
Study group	Role	What they receive
trospium chloride XR 60 mg	Experimental	Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks. Receives: Drug: Trospium Chloride, Extended Release (XR); Other: placebo
placebo	Placebo comparator	Placebo capsule taken orally once daily for 14 weeks. Receives: Other: placebo

What is being measured

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

Percent Change From Baseline in Urinary Urgency Incontinence (UUI)
Patients recorded information about UUI (accidental leakage, urgency associated with void and urgency severity) in a 3-day diary at Baseline (Week 2) and Week 14. The daily average episodes of UUI was the sum of all UUI episodes over valid diary days during the 3-day diary period divided by the valid number of diary days with at least one valid bladder entry. The percent change from baseline was calculated as (Mean UUI at Week 14- Mean UUI at Week 2)/ Mean UUI at Week 2 X 100. A negative number percent change from baseline indicated an improvement.
Measured: Baseline (Week 2), Week 14

Secondary outcomes (4)

Percent Change From Baseline in Urgency Severity Associated With Toilet Voids
Due to lack of evaluable data, analysis for this outcome measure was not performed.
Measured: Baseline (Week 2), Week 14
Percent Change From Baseline in Voided Volume
Due to lack of evaluable data, analysis for this outcome measure was not performed.
Measured: Baseline (Week 2), Week 14
Percent Change From Baseline in Over Active Bladder (OAB)-Symptom Composite Score
Due to lack of evaluable data, analysis for this outcome measure was not performed.
Measured: Baseline (Week 2), Week 14
Percent Change From Baseline in Percentage of Patients Continent
Due to lack of evaluable data, analysis for this outcome measure was not performed.
Measured: Baseline (Week 2), Week 14

Timeline

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

Jul 2009Dec 2011

First posted2 Jul 2009 (estimated)
Study startJul 2009
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ObesityStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 127 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00932022
Sponsor's protocol ID: MA-SXR-09-003
Other IDs: Sanctura XR obesity OAB Trial
Status last verified: Dec 2012
First submitted: 1 Jul 2009
Last updated: 21 Jan 2013
Results posted: Yes, on ClinicalTrials.gov
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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Study at a glance

From the registry record, last updated by the sponsor on 21 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Trospium Chloride XR in Obese Female Patients With Overactive Bladder
ClinicalTrials.gov ID: NCT00932022
Acronym / sponsor ID: MA-SXR-09-003
Conditions: Obesity, Overactive Bladder, Incontinence
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 127 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 2 Jul 2009 (estimated)
Results: Posted 21 Jan 2013

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
trospium chloride XR 60 mg	Experimental	Drug: Trospium Chloride, Extended Release (XR), Other: placeboPlacebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
placebo	Placebo comparator	Other: placeboPlacebo capsule taken orally once daily for 14 weeks.

Who may qualify

Ages: 18 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

OAB syndrome with Urgency, Urinary frequency and Urgency urinary incontinence
Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the screening visit).
Obese

Key exclusion criteria (6 listed)

Chronic kidney failure
Abdominal bypass surgery for obesity
Moderate or severe memory impairment
Uncontrolled narrow angle glaucoma
Uncontrolled systemic disease

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
Trospium Chloride, Extended Release (XR)Also: Sanctura XR™ 60 mgTrospium chloride extended release 60 mg capsule taken orally once daily for 12 weeks.	Drug	trospium chloride XR 60 mg
placeboPlacebo capsule taken orally once daily for either 2 weeks or 14 weeks.	Other	placebo, trospium chloride XR 60 mg

Primary outcome

Percent Change From Baseline in Urinary Urgency Incontinence (UUI)
Time frame: Baseline (Week 2), Week 14
Patients recorded information about UUI (accidental leakage, urgency associated with void and urgency severity) in a 3-day diary at Baseline (Week 2) and Week 14. The daily average episodes of UUI was the sum of all UUI episodes over valid diary days during the 3-day diary period divided by the valid number of diary days with at least one valid bladder entry. The percent change from baseline was calculated as (Mean UUI at Week 14- Mean UUI at Week 2)/ Mean UUI at Week 2 X 100. A negative number percent change from baseline indicated an improvement.

4 secondary outcomes

Percent Change From Baseline in Urgency Severity Associated With Toilet Voids
Time frame: Baseline (Week 2), Week 14
Percent Change From Baseline in Voided Volume
Time frame: Baseline (Week 2), Week 14
Percent Change From Baseline in Over Active Bladder (OAB)-Symptom Composite Score
Time frame: Baseline (Week 2), Week 14
Percent Change From Baseline in Percentage of Patients Continent
Time frame: Baseline (Week 2), Week 14

Results and safety

Results posted to the registry on 21 Jan 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Trospium Chloride XR 60 mg	64	59
Placebo	63	59

Primary outcome: Percent Change From Baseline in Urinary Urgency Incontinence (UUI)

Time frame: Baseline (Week 2), Week 14. Mean (Standard Deviation). Unit: Percent change

Measure	Trospium Chloride XR 60 mg n = 54	Placebo n = 49
Value	-23.7 (36.16)	57.8 (275.3)

Population analysed: Modified Intent-to-Treat (mITT) defined as all patients who were randomized and received at least one dose of study medication. Analysis below was done on patients from the mITT population who completed the study at Week 14 and who had data available for this outcome measure.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Trospium Chloride XR 60 mg	0 of 64 (0%)	6 of 64 (9.4%)	Not reported
Placebo	1 of 63 (1.6%)	3 of 63 (4.8%)	Not reported

Limitations and caveats (from the sponsor): Due to lack of evaluable data, analysis for the secondary outcome measures was not performed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Medical Director study director

Allergan

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Trospium Chloride, Extended Release (XR) in people with Obesity and Overactive Bladder, run by Allergan at 1 site 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 3 inclusion and 6 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 21 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 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Change From Baseline in Urinary Urgency Incontinence (UUI) (time frame: Baseline (Week 2), Week 14). 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 NCT00932022.

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 21 Jan 2013.