A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of L-000796568 in Postmenopausal Women With Overactive Bladder - L-000796568 Overactive Bladder Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004499-19-IE

Enrollment

Unknown

Registered

2005-10-06

Start date

2005-11-22

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overative Bladder MedDRA version: 8.0 Level: LLT Classification code 10059617

Interventions

Product Name: L-000796568, L-000796568-001T, MK-0634 Product Code: L-000796568, L-000796568-001T, MK-0634 Pharmaceutical Form: Tablet INN or Proposed INN: N/A CAS Number: N/A Current Sponsor code: N/A

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Postmenopausal females (ages 40-74 inclusive) with predominantly urge urinary incontinence overactive bladder episodes. Patients must meet minimum eligibility requirements of average number of = 8 micturitions/day and average number of = 1 urge incontinence episode/day based on screening and run-in diary cards. Are the trial subjects under 18? Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients must not suffer from diabetes insipidus, hyperglycemia, hypercalcemia, orthostatic hypotension or active/recurrent urinary tract infections (>6 episodes per year). Patients must be willing to discontinue their current OAB medication therapy. Patients must not be taking any strong or moderate CYP3A4 inducers or inhibitors.

Design outcomes

Primary

Measure	Time frame
Main Objective: In postmenopausal women with overactive bladder: (1) To investigate a dose-related reduction, in average number of daily micturitions after 8 weeks of treatment with L 000796568 (375, 125, or 50 mg once daily), compared with placebo. (2) To evaluate the safety and tolerability of daily treatment with L-000796568 (375, 125, or 50 mg/d). ;Secondary Objective: (1) To determine whether daily treatment with L-000796568 (375, 125, or 50 mg/d) decreases the average number of total incontinence episodes and urge incontinence episodes per day compared with placebo. (2) To determine whether daily treatment with L-000796568 (375, 125, or 50 mg/d) decreases the average number of urgency (strong urge to urinate immediately) episodes per day compared with placebo.;Primary end point(s): a. Will demonstrate a dose-related reduction, compared with placebo, in average number of daily micturitions at Week 8. b. Will be safe and well tolerated at all dose levels over 8 weeks of treatment.	—

Measure

Time frame

Main Objective: In postmenopausal women with overactive bladder: (1) To investigate a dose-related reduction, in average number of daily micturitions after 8 weeks of treatment with L 000796568 (375, 125, or 50 mg once daily), compared with placebo. (2) To evaluate the safety and tolerability of daily treatment with L-000796568 (375, 125, or 50 mg/d). ;Secondary Objective: (1) To determine whether daily treatment with L-000796568 (375, 125, or 50 mg/d) decreases the average number of total incontinence episodes and urge incontinence episodes per day compared with placebo. (2) To determine whether daily treatment with L-000796568 (375, 125, or 50 mg/d) decreases the average number of urgency (strong urge to urinate immediately) episodes per day compared with placebo.;Primary end point(s): a. Will demonstrate a dose-related reduction, compared with placebo, in average number of daily micturitions at Week 8. b. Will be safe and well tolerated at all dose levels over 8 weeks of treatment.

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Countries

Ireland, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026