Prospective, randomized, open, crossover, patient preference study comparing oral immediate release and transdermal oxybutynin in overactive bladder patients

• Conditions: •Male or female (18 – 80 years) suffering from OAB.•Symptoms of OAB as defined by:Urgency frequency =7 /week,•Urinary urgency incontinence (= 7 UIE/week),•Urodynamically proven detrusor instability; MedDRA version: 9.1Level: LLTClassification code 10059617Term: Overactive bladder

• Registration Number: EUCTR2006-000475-16-DE
• Lead Sponsor: Johannes Gutenberg-Universität Mainz, Urologische Klinik (ausführende Stelle), Prof. Dr. med. Thürof

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Male or female (18 – 80 years) suffering from OAB.
•Symptoms of OAB as defined by:
•Urgency frequency =7 /week
•Urinary urgency incontinence (= 7 UIE/week)
•Urodynamically proven detrusor instability
•Women must be surgically sterile or
•Women must be postmenopausal (postmenopausal means a period after menopause, thus the time of the last menstruation, which follows retrospectively two years long no further ovariell controlled uterine bleeding) or
•Women mus be older than 55 years and received in the last 5 months no hormone substitution therapy or
•Women must agree to use effective contraception during treatment phases (i.e. contraceptions with a failure ratio of < 1%/year are implants, injection preparations, combined oral contraceptiva, intrauterine device (e.g. hormone spiral) or vasectomy of the partner)
•Negative urine pregnancy test for women capable of child-bearing within 24 hours before income of the first dose medication at V1.
•Signed and dated informed consent of the subject must be available before start of any specific trial procedures.
•Ability of subject to understand character and individual consequences of clinical trial.

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

Subjects presenting with any of the following criteria as according to their history will not be included in the trial:
•Pregnancy and lactation.
•History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
•Subjects with uncontrolled arterial hypertension (systolic blood pressure > 160 mmHg and diastolic blood pressure > 100 mmHg)
•Subjects with clinically relevant arrhythmic changes in ECG (e.g. AV-block grade II or III, QT-prolongations, Long QT syndrome)
•Subjects with factors of risk for Torsade de Pointes
•Subjects with cardiac insufficiency (NYHA II – NYHA IV)
•Subjects with hypokalaemia
•Subjects with drugs which have prolongation potential
•Subjects with coronary heart disease (CHD)
•Subjects with hyperthyroidism
•Subjects being treated with CYP3A4-inhibitors like azole antifungals (e.g. ketoconasole) or macrolid antibiotics (e.g. erythromycin).
•Subjects with uncontrolled narrow-angle glaucoma.
•Subjects with myasthenia gravis.
•Subjects with significant urinary obstruction as measured during cystometry (e.g. prostatic hyperplasia, stricture of urethra).
•Subjects with significant obstructions in the area of the residual urinary tract and the gastrointestinal tract.
•Subjects with intestinal atony or bowel obstruction.
•Subjects with severe gastro-intestinal condition (e.g. severe ulcerative colitis or toxic megacolon).
•Subjects with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
•Subjects with urinary frequency or nocturia due to cardiac or renal insufficiency and without urgency.
•Subjects with severe liver insufficiency (e.g. cirrhosis, CHILD-Pugh B and C ).
•Subjects with severe kidney insufficiency (Creatinin-Clearance < 30 ml/min).
•Subjects with urinary retention.
•Subjects with hiatus hernia and reflux oesophagitis
•Subjects with acute prostatitis.
•Subjects with tachyarrhythmia (pulse > 100/min).
•Subjects with Parkinson`s disease or Alzheimer`s disease or other cerebral diseases.
•Subjects being treated with other anticholinergics or drugs with anticholinergic activity, such as amantadine and other anticholinergic antiparkinsonian drugs (e.g. biperiden, levodopa), antihistamines, antipsychotics (e.g. phenothiazines, butyrophenones), quinidine, tricyclic antidepressants, atropine and related compounds.
•Subjects with cognitive impairment, not able to understand content and aim of the trial.
•Refractory to antimuscarine treatment: Subjects having experienced no benefit from previous treatment with oral or transdermal oxybutynin.
•Medical or psychological condition that would not permit completion of the trial or signing of informed consent.
•Participation in other clinical trials and observation period of competing trials, respectively.
•Subjects who have previously been enrolled in the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified