Doppelblinde, randomisierte, Placebo-kontrollierte Studie der Phase III zur Bestimmung der Wirksamkeit, Verträglichkeit und Sicherheit von intravesikal verabreichter Oxybutynin-Lösung bei Kindern/Jugendlichen mit neurogen bedingter Detrusorhyperaktivität

• Conditions: bladder disorder (detrusor hyperactivity caused by neurogenic disorder); MedDRA version: 9.1Level: LLTClassification code 10061011Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2008-007053-13-DE
• Lead Sponsor: Grachtenhaus-Apotheke, Inh. Klaus Stegemann e. K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

- written informed consent of patients and their legal representatives obtained
- patients of both gender
- patients aged 6-16 years inclusive, with a body weight of at least 15 kg to a maximum of 80 kg
- patients, who are performing clean (or sterile) intermittent catheterization (CIC)
- patients with detrusor hyperactivity confirmed by urodynamic measurement within the last 24 months and associated with a known neurological deficit
- patients with a leak-point-pressure of > 40 mm or patients with a leak-point-pressureof = 40 mm paralleled by incontinence within the catheterization inverval
- patients having failed to treatment with orally administered anticholinergic medication or in which treatment had been terminated due to adverse drug effects other than allergic reaction
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- patients with clinically significant abnormalities (unrelated to the trial indication), found at, or before randomization, as well as clinically significant findings during the physical examination, as determined by the investigator
- patients with clinically significant conditions which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the patient's ability to participate in the study
- patients with clinically significant laboratory abnormalities (based on investigator judgment) or laboratory values greater than 2 times the upper limit of normal range
- patients with a history of relevant orthostatic hypotension, fainting spells or blackouts
- patients with intolerance to the active ingredient oxybutynin
- patients with clinical pictures like polyuria or nycturia due to heart or renal failure, subvesical organic urinary output failure (e. g. prostataadenom, urethral stricture), constrictions (stenosis) in the area of the remaining urinary passage and gastrointestinal tract, acute angle-closure glaucoma (glaucoma) or complanate anterior chamber, fast and abnormal heartbeat (cardiac tachyarrhythmia), heavy colon aneurysma (toxic megacolon), heavy arteriosclerotic alteration of the celebral vessels (cerebrosclerosis), intestinal obstruction, hiatal hernia with reflux esophagitis, phlogistic colon ulcer, colon atresia
- patients with obstructive uropathy
- patients with Myasthenia gravis and / or severe Colitis ulcerosa
- patients with severe hydronephrosis greater than Grade 3; a renal ultrasound performed within 3 months prior to entering the study will be accepted as a baseline measurement if this assessment was performed while the patient was on a stable medication regimen
- patients with a known severe vesical-renal reflux higher than Grade 3 according to Parkkulainen
- patients with severe limitations in renal function according to laboratory chemical determination of renal function values
- patients with a pathological intraocular pressure – measured within 12 month prior to entering the study
- patients with a lifetime history of bladder neck surgery, bladder augmentation or permanently exteriorized bladder drainage procedures and those patients who have had any surgical procedure under general anaesthesia within 30 days prior to screening visit
- patients and their legal representatives with a significant psychiatric disorder (based on investigator discretion) that prevents their comprehension of consent and their ability to comply with the protocol
- patients on drug therapy, or non-drug therapy including electrostimulation for their neuropathic bladder initiated during the four weeks prior to screening or anticipated to initiate during the study
- patients who have a history of allergy/hypersensitivity (including drug and sulfa allergy) which is deemed relevant to the trial as judged by the investigator
- patients taking warfarin, ranitidine or cimetidine
- patients receiving CYP3A4 inhibiting pharmaceuticals or substances like Clomipramine, Itraconazole, Ketoconazole, Testosterone, Troleandomycin or rather CYP2D6 inhibiting pharmaceuticals like Dextromethorphan
- patients receiving anticholinergic or anticholinergic acting pharmaceuticals enhancing the function of oxybutynin, e. g. Amantadin and other Anti-Parkinson’s pharmaceuticals, Antihistamines, Neuroleptics, Chinidin, Digitalis, trizyclic Antidepressants, Atropi

Study & Design

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