A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)

A Phase 1 study testing tolterodine tartrate in people with Overactive Bladder, run by Merck Sharp & Dohme LLC.

Completed

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

Trial summary

This study will design an alternative urodynamic platform to better evaluate treatment effects of medications for overactive bladder. Part II is dependent on results of Part I and may not be conducted. Read more about this study

Who is it for?: Ages 40 to 75 years, women only
Conditions the study is for: Overactive Bladder
What is being tested?: tolterodine tartrate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: No sites listed yet
Study dates: 3 Sep 2008to 19 Jan 2009
Phase: Phase 1
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 40 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient is a postmenopausal female 40 to 75 years of age
Patient has a Body Mass Index (BMI) less than or equal to 35 kg/m2
Patient has a documented history of overactive bladder for at least 6 months prior to screening

Who cannot join

Patient has stress or mixed incontinence
Patient has a history of interstitial cystitis, painful bladder syndrome, or chronic pelvic pain
Patient has a history of stroke, seizures, or major neurological disorders
Patient has a history of fecal incontinence
Patient has a history of continual urine leakage
Patient has had surgery to correct stress urinary incontinence or pelvic organ prolapse within 6 months of study start

Show all 16Show fewer

Patient received bladder training of electrostimulation within 2 weeks of study start
Patient requires a catheter
Patient is taking medications that cannot be stopped for the duration of the trial including certain anticholinergics or smooth muscle relaxants
Patient began taking tricyclic antidepressants, serotonin/norepinephrine reuptake inhibitors, calcium channel blockers, ephedrine/pseudoephedrine, or diuretic therapy less than 8 weeks before study start
Patient has been on hormone replacement therapy for less than 12 weeks at study start
Patient must take medication for arrhythmia
Patient consumes more than 2 alcoholic beverages per day
Patient consumes more than 3 servings of caffeinated beverages per day (1 serving = 120 mg caffeine)
Patient has multiple and/or severe allergies to foods and drugs
Patient regularly uses any illegal drugs

About this study

Official title: A Randomized, Placebo Controlled, Crossover Study to Evaluate the Effects of Tolterodine Tartrate on Urodynamic Parameters in Patients With Overactive Bladder

Conditions: Overactive Bladder
Being tested: tolterodine tartrate, Comparator: Placebo to tolterodine tartrate
Medical subject headings: Urinary Bladder, Overactive

What participants receive

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

tolterodine tartrateDrug
Part I: tolterodine tartrate 4 mg capsule once a day (qd) for 7 days
Part IIa: tolterodine tartrate 4 mg capsule qd for 7 days
Part IIb: single dose tolterodine tartrate 4 mg capsule
Comparator: Placebo to tolterodine tartrateDrug
Part I: placebo to tolterodine tartrate 4 mg capsule once a day (qd) for 7 days
Part IIa: placebo to tolterodine tartrate 4 mg capsule qd for 7 days
Part IIb: single dose placebo to tolterodine tartrate 4 mg capsule

Study groups in NCT00768521
Study group	Role	What they receive
1	Experimental	Part I, Sequence 1: tolterodine tartrate crossing over to matching placebo Receives: Drug: tolterodine tartrate; Drug: Comparator: Placebo to tolterodine tartrate
2	Experimental	Part I, Sequence 2: placebo crossing over to study drug 4 mg once a Day (qd) Receives: Drug: tolterodine tartrate; Drug: Comparator: Placebo to tolterodine tartrate
3	Experimental	Part II, Sequence 1: study drug crossing over to placebo Receives: Drug: tolterodine tartrate; Drug: Comparator: Placebo to tolterodine tartrate
4	Experimental	Part II, Sequence 2: placebo crossing over to study drug Receives: Drug: tolterodine tartrate; Drug: Comparator: Placebo to tolterodine tartrate

What is being measured

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

Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo
Change from baseline in maximum cystometric capacity at 4 hours post dose 7 on tolterodine 4 mg and placebo (analysis on natural log transformed data)
Measured: 4 hours post dose 7

Secondary outcomes (1)

Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 1 on Tolterodine 4 mg and Placebo
Change from baseline in maximum cystometric capacity at 4 hours post dose 1 on tolterodine 4 mg and placebo (analysis on natural log transformed data)
Measured: 4 hours post dose 1

Timeline

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

3 Sep 200819 Jan 2009

First posted8 Oct 2008 (estimated)
Study start3 Sep 2008
Primary completion19 Jan 2009
Study completion19 Jan 2009

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Overactive BladderStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00768521
Sponsor's protocol ID: 0000-107
Other IDs: 2008_560
Status last verified: Jan 2018
First submitted: 7 Oct 2008
Last updated: 22 Feb 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Frenkl T, Railkar R, Shore N, Bailen J, Sutherland S, Burke J, Scott BB, Ruddy M, Beals C. Evaluation of an experimental urodynamic platform to identify treatment effects: a randomized, placebo-controlled, crossover study in patients with overactive bladder. Neurourol Urodyn. 2012 Jan;31(1):69-74. doi: 10.1002/nau.21094. Epub 2011 Sep 8.
PubMed 21905086

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?

Official record

Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
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UCon Treatment of Overactive Bladder (OAB) in Males
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Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
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RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
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All Overactive Bladder trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Placebo Controlled, Crossover Study to Evaluate the Effects of Tolterodine Tartrate on Urodynamic Parameters in Patients With Overactive Bladder
ClinicalTrials.gov ID: NCT00768521
Acronym / sponsor ID: 0000-107
Conditions: Overactive Bladder
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 3 Sep 2008 (actual)
Primary completion: 19 Jan 2009 (actual)
Study completion: 19 Jan 2009 (actual)
First posted: 8 Oct 2008 (estimated)
Results: Posted 19 Aug 2014

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: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Drug: tolterodine tartrate, Drug: Comparator: Placebo to tolterodine tartratePart I, Sequence 1: tolterodine tartrate crossing over to matching placebo
2	Experimental	Drug: tolterodine tartrate, Drug: Comparator: Placebo to tolterodine tartratePart I, Sequence 2: placebo crossing over to study drug 4 mg once a Day (qd)
3	Experimental	Drug: tolterodine tartrate, Drug: Comparator: Placebo to tolterodine tartratePart II, Sequence 1: study drug crossing over to placebo
4	Experimental	Drug: tolterodine tartrate, Drug: Comparator: Placebo to tolterodine tartratePart II, Sequence 2: placebo crossing over to study drug

Who may qualify

Ages: 40 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patient is a postmenopausal female 40 to 75 years of age
Patient has a Body Mass Index (BMI) less than or equal to 35 kg/m2
Patient has a documented history of overactive bladder for at least 6 months prior to screening

Key exclusion criteria (16 listed)

Patient has stress or mixed incontinence
Patient has a history of interstitial cystitis, painful bladder syndrome, or chronic pelvic pain
Patient has a history of stroke, seizures, or major neurological disorders
Patient has a history of fecal incontinence
Patient has a history of continual urine leakage

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
tolterodine tartratePart I: tolterodine tartrate 4 mg capsule once a day (qd) for 7 days Part IIa: tolterodine tartrate 4 mg capsule qd for 7 days Part IIb: single dose tolterodine tartrate 4 mg capsule	Drug	1, 2, 3, 4
Comparator: Placebo to tolterodine tartratePart I: placebo to tolterodine tartrate 4 mg capsule once a day (qd) for 7 days Part IIa: placebo to tolterodine tartrate 4 mg capsule qd for 7 days Part IIb: single dose placebo to tolterodine tartrate 4 mg capsule	Drug	1, 2, 3, 4

Primary outcome

Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo
Time frame: 4 hours post dose 7
Change from baseline in maximum cystometric capacity at 4 hours post dose 7 on tolterodine 4 mg and placebo (analysis on natural log transformed data)

1 secondary outcome

Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 1 on Tolterodine 4 mg and Placebo
Time frame: 4 hours post dose 1

Results and safety

Results posted to the registry on 19 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tolterodine Then Placebo	9	9
Placebo Then Tolterodine	11	11

Primary outcome: Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo

Time frame: 4 hours post dose 7. Least squares mean (90% Confidence Interval). Unit: Percentage change

Measure	Tolterodine n = 20	Placebo n = 20
Value	1.15 (0.06)	0.94 (0.06)

Tolterodine vs Placebo: Mean Difference (Final Values): 23.18 (90% CI 7.58 to 41.06), p = 0.008, ANCOVA

Population analysed: All patients

1 secondary outcome is reported in the full results.

Adverse events

Time frame: The adverse experiences reporting are from the randomization visit to follow-up phone call.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tolterodine	0 of 20 (0%)	2 of 20 (10%)	Not reported
Placebo	0 of 20 (0%)	1 of 20 (5%)	Not reported

Limitations and caveats (from the sponsor): The analysis presented includes all patients. An analysis excluding patients who were misdosed yielded different results with a similar conclusion and are not presented.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21905086Frenkl T, Railkar R, Shore N, Bailen J, Sutherland S, Burke J, Scott BB, Ruddy M, Beals C. Evaluation of an experimental urodynamic platform to identify treatment effects: a randomized, placebo-controlled, crossover study in patients with overactive bladder. Neurourol Urodyn. 2012 Jan;31(1):69-74. doi: 10.1002/nau.21094. Epub 2011 Sep 8.

Related trials for Overactive Bladder

Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
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Recruiting
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Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
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RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)

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 Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing tolterodine tartrate in people with Overactive Bladder, run by Merck Sharp & Dohme LLC.

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 16 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 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 19 Aug 2014). 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?

Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo (time frame: 4 hours post dose 7). 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 NCT00768521, which also lists 1 linked publication.

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 22 Feb 2018.