E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059617 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
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E.2.2 | Secondary objectives of the trial |
(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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 10 |