A Phase 2 interventional study of MK-0634 50 mg and MK-0634 125 mg in Urinary Incontinence, sponsored by Merck Sharp & Dohme LLC. Completed. Open to female participants aged 40 Years to 74 Years. Per ClinicalTrials.gov, last updated 2015-12-17.
Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Treatment
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.
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.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 848 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All participants will receive placebo for the 1 week prior to randomization
Drug: MK-0634 50 mg
All participants will receive placebo for the 1 week prior to randomization
Drug: MK-0634 125 mg
All participants will receive placebo for the 1 week prior to randomization
Drug: MK-0634 125 mg
All participants will receive placebo for the 1 week prior to randomization
Drug: Placebo for MK-0634
one capsule orally, once daily in morning
Also known as: L-000796568
one or three capsules orally, once daily in morning
Also known as: L-000796568
one, two, three or four capsules orally once daily in morning
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
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
No study locations are listed for this record.
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Merck Sharp & Dohme LLC