A phase IIa, multi-centre, randomised, placebo-controlled, double-blind, parallel group study of TA-5538, in patients with overactive bladder

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 225

Inclusion Criteria

Eligible patients will meet ALL of the following criteria:
- Males or females (females must not be of childbearing potential, i.e. postmenopausal for at least one year or surgically sterile). Males must be vasectomised or must use reliable contraceptives during the study period.
- Aged 18-75 years inclusive.
- Patients must exhibit all of the following symptoms of OAB during the last week of the 2 week placebo run-in period (this information will be collected using a patient diary):
frequency of micturition - at least 8 voids per day on average, over 3 days.
urgency incontinence - at least 2 episodes per day on average, over 3 days.
- Patients must have had symptoms of OAB for = 6 months.
Are the trial subjects under 18? no
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

Patients will be ineligible for this study based on ANY ONE of the following criteria:
- Patients with stress or mixed incontinence where the predominant component is the stress, as assessed by the investigator (symptoms or stress test)
- Patients with a known neurological disease which is thought to affect the bladder.
- Male patients with significant outlet obstruction (flow rate: = 12mL/sec).
- Patients with a post void residual (PVR) volume of urine > 150mL.
- Patients with a urine mean volume more than 2.5 L per day.
- Patients with bladder stones.
- Patients with active or recurrent urinary tract infection (UTI). Evidence of UTI at screening , or unexpected haematuria will prevent patients from entering the study until this matter is clinically resolved.
- Patients with painful bladder syndrome/bladder pain.
- Patients with malignancy, except squamous cell carcinoma (skin cancer).
- Patients with known fibroids.
- Ongoing treatment with any of the following medications or treatment within 2 weeks prior to the placebo run-in period (Week -2 Visit):
antichloinergic/antispasmodic drugs (such as oxybutynin, tolterodine, solifenacin, darifenacin, hyoscyamine, propantheline, trospium or flavoxate)
diuretics
other drugs with significant anticholinergic effects (such as imipramine and most other tricyclic antidepressants, however mianserin and trazodone are permitted)
drugs that significantly inhibit CYPs (such as ritonavir, sachinavir, itoconazole, ketoconazole, troleandomycin, miconazole, nefazodone mibefradil, clarithromycin, glibenclamide, clotrimazole)
-Hormone replacement therapy (estrogens) if taken less than 3 months before the placebo run-in period (Week -2 visit).
-Patients on long term stable-dose treatment with other drugs are not excluded as long as treatment remains stable during the study.
-Evidence of hepatic disease (AST (SGOT), or ALT (SGPT), or total bilirubin > 1.5 x upper limit of normal, or ALP > 1.2 x upper limit of normal); other abnormalities in screening laboratory tests which in the judgement of the investigator and/or sponsor clinician would interfere with the patient's participation in the study.
-Patients with cystocoele beyond the hymen and patients with significant symptomatic prolapse.
- Patients who have undergone urogenital surgery.
- Patients with other clinically significant systemic diseases.
- Patients who intend to start a bladder training programme while in the study. Patients on such a programme at study entry may not modify or discontinue their bladder training during the course of the study.
- Patients with an indwelling catheter and patients practicing intermittent self-cathererisation.
- Patients who have received any investigational drug during the preceding 12 weeks prior to the placebo run-in period (Week -2 visit).
- Patients who in the opinion of the investigator, or that of sponsor's clinician, are unable and/or unlikely to comprehend and follow the study procedures and instructions.
- Patients who are abusers of alcohol and/or other drugs.
- Patients who intend to donate blood or blood products during the study or within one month following the completion of the study.
- Patients with history of any clinically significant drug allergy.
- Patients not capable of independent toileting.
- Patients not capable of independentlty completing the patient diary.
- Patients not willing to give informed consent by signing and dating an informed consent form prior to study entry.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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