Urinary IncontinencePhase 2NCT00231790
A Placebo-Controlled Study of MK0634 in Patients With Overactive Bladder (0634-007)
A Phase 2 study testing MK-0634 50 mg and MK-0634 125 mg in people with Urinary Incontinence, run by Merck Sharp & Dohme LLC.
Trial summary
Overactive bladder is very prevalent in postmenopausal women. The current study is designed to investigate whether a new drug may offer safe and effective treatment. Read more about this study
- Who is it for?
- Ages 40 to 74 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- MK-0634 50 mg and MK-0634 125 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 848 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Oct 2006
- 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 40 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal females (ages 40-74) with predominantly urge urinary incontinence overactive bladder episodes.
- Patients must meet minimum eligibility requirements (e.g., average number of micturitions/day) based on screening diary cards.
Who cannot join
- Patients must not suffer from diabetes insipidus
- Hyperglycemia
- Hypercalcemia
- Orthostatic hypotension
- Active/recurrent urinary tract infections (>6 episodes per year)
- Patients must be willing to discontinue their current OAB medication therapy.
About this study
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of MK0634 in Postmenopausal Women With Overactive Bladder
Overactive bladder is very prevalent in postmenopausal women. The current study is designed to investigate whether a new drug may offer safe and effective treatment.
Read the detailed description
Clinical development of MK-0634 was discontinued. Study MK-0634-027 was a safety follow-up study to determine if there were any ocular effects of MK-0634 in participants from the United Kingdom who were exposed to MK-0634 during the 007 study.
- Conditions
- Urinary Incontinence
- Being tested
- MK-0634 50 mg, MK-0634 125 mg, Placebo for MK-0634
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-0634 50 mgDrug
Also called L-000796568
one capsule orally, once daily in morning
MK-0634 125 mgDrug
Also called L-000796568
one or three capsules orally, once daily in morning
Placebo for MK-0634Drug
one, two, three or four capsules orally once daily in morning
| Study group | Role | What they receive |
|---|---|---|
| MK-0634 50 mg | Experimental | All participants will receive placebo for the 1 week prior to randomization Receives: Drug: MK-0634 50 mg |
| MK-0634 125 mg | Experimental | All participants will receive placebo for the 1 week prior to randomization Receives: Drug: MK-0634 125 mg |
| MK-0634 375 mg | Experimental | All participants will receive placebo for the 1 week prior to randomization Receives: Drug: MK-0634 125 mg |
| Placebo | Placebo comparator | All participants will receive placebo for the 1 week prior to randomization Receives: Drug: Placebo for MK-0634 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the number of micturitions per day averaged over a diary card week (4 to 10 days)
Measured: Baseline and Week 8
Proportion of participants with abnormal retinal photography (Follow-up Study 007 only)
Measured: Day 1 of Follow-up
Proportion of participants with abnormal visual field test (Follow-up Study 007 only)
Measured: Day 1 of Follow-up
Secondary outcomes (3)
Change from baseline in the number of total incontinence episodes
Measured: Baseline and Week 8
Number of urge-incontinence episodes
Measured: Up to 8 weeks
Number of urgency episodes per day averaged over a diary card week (4 to 10 days)
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startAug 2005
- Primary completionSep 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 848 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231790
- Sponsor's protocol ID
- 0634-007
- Other IDs
- 2005_045
- Status last verified
- Dec 2015
- First submitted
- 30 Sep 2005
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of MK0634 in Postmenopausal Women With Overactive Bladder
- ClinicalTrials.gov ID
- NCT00231790
- Acronym / sponsor ID
- 0634-007
- Conditions
- Urinary Incontinence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 848 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 4 Oct 2005 (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.
Overactive bladder is very prevalent in postmenopausal women. The current study is designed to investigate whether a new drug may offer safe and effective treatment.
Detailed description
Clinical development of MK-0634 was discontinued. Study MK-0634-027 was a safety follow-up study to determine if there were any ocular effects of MK-0634 in participants from the United Kingdom who were exposed to MK-0634 during the 007 study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MK-0634 50 mg | Experimental | Drug: MK-0634 50 mgAll participants will receive placebo for the 1 week prior to randomization |
| MK-0634 125 mg | Experimental | Drug: MK-0634 125 mgAll participants will receive placebo for the 1 week prior to randomization |
| MK-0634 375 mg | Experimental | Drug: MK-0634 125 mgAll participants will receive placebo for the 1 week prior to randomization |
| Placebo | Placebo comparator | Drug: Placebo for MK-0634All participants will receive placebo for the 1 week prior to randomization |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal females (ages 40-74) with predominantly urge urinary incontinence overactive bladder episodes.
- Patients must meet minimum eligibility requirements (e.g., average number of micturitions/day) based on screening diary cards.
Key exclusion criteria (6 listed)
- Patients must not suffer from diabetes insipidus
- Hyperglycemia
- Hypercalcemia
- Orthostatic hypotension
- Active/recurrent urinary tract infections (>6 episodes per year)
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 |
|---|---|---|
| MK-0634 50 mgAlso: L-000796568one capsule orally, once daily in morning | Drug | MK-0634 50 mg |
| MK-0634 125 mgAlso: L-000796568one or three capsules orally, once daily in morning | Drug | MK-0634 125 mg, MK-0634 375 mg |
| Placebo for MK-0634one, two, three or four capsules orally once daily in morning | Drug | Placebo |
Primary outcome
Change from baseline in the number of micturitions per day averaged over a diary card week (4 to 10 days)
Time frame: Baseline and Week 8
Proportion of participants with abnormal retinal photography (Follow-up Study 007 only)
Time frame: Day 1 of Follow-up
Proportion of participants with abnormal visual field test (Follow-up Study 007 only)
Time frame: Day 1 of Follow-up
3 secondary outcomes
Change from baseline in the number of total incontinence episodes
Time frame: Baseline and Week 8
Number of urge-incontinence episodes
Time frame: Up to 8 weeks
Number of urgency episodes per day averaged over a diary card week (4 to 10 days)
Time frame: up to 8 weeks
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 17 Dec 2015.
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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 Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MK-0634 50 mg and MK-0634 125 mg in people with Urinary Incontinence, 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 2 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 17 Dec 2015. 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. 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 from baseline in the number of micturitions per day averaged over a diary card week (4 to 10 days) (time frame: Baseline and Week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2015.