E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To evaluate the safety and efficacy of AGN-214868 compared with placebo in the treatment of patients with idiopathic overactive bladder (IOAB) and urinary incontinence. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059617 |
E.1.2 | Term | Overactive bladder |
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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 |
AGN-214868 has an acceptable safety profile in patients with IOAB AGN-214868 is more efficacious than placebo in reducing symptoms of IOAB
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E.2.2 | Secondary objectives of the trial |
Evaluate the pharmacokinetic profile of AGN214868 in patients suffering from idiopathic OAB Compare the safety and efficacy profiles of different doses of AGN214868
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female, 18 to 75 years of age IOAB with urinary incontinence Patient not adequately managed with previous anticholinergic agents ≥ 24 micturitions during 3-day bladder diary ≥ 6 urgency episodes during 3-day bladder diary ≥ 1 urinary incontinence episode during 3-day bladder diary If female, must be of nonreproductive potential (see Section 4.6.1) If male, must be willing to use a double-barrier method of contraception during sexual intercourse with partners of reproductive potential or abstain from intercourse (see Section 4.6.2)
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E.4 | Principal exclusion criteria |
Neurogenic overactive bladder A predominance of stress incontinence Previous botulinum toxin therapy of any serotype for any urologic condition Post void residual (PVR) urine volume of > 100 mL History or evidence of any condition, other than OAB, that may affect bladder function or may put the patient at risk or interfere with the integrity of the data
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy measure: The change from study baseline at week 12 post treatment in the number of micturition episodes, with study baseline value defined as thenumber of micturition episodes prior to the treatment.
Safety: Adverse events, serious adverse events, and serious medical events Physical examinations Vital signs Pregnancy testing Urine dipstick reagent test Central laboratory urine analysis (with urine culture/sensitivity, as applicable) Urine cytology Hematology and serum chemistry Kidney and bladder ultrasound PVR urine measurement 12-lead electrocardiogram (ECG) Blood samples for pharmacokinetic assessment Blood samples for immunogenicity analysis
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |