An uncontrolled, open-label, titration, long-term safety up to 12 months and efficacy study of tamsulosin hydrochloride in children with neuropathic bladder, with a randomized pharmacokinetic sub-study investigating low, medium and high dose ranges - ND
- Conditions
- eurogenic bladderMedDRA version: 9.1Level: LLTClassification code 10029279Term: Neurogenic bladder
- Registration Number
- EUCTR2006-004423-11-IT
- Lead Sponsor
- BOEHRINGER ING.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 260
-Signed and dated written informed consent by the parent or guardian and, where appropriate, informed assent by the child, prior to admission into the study in accordance with GCP and the local legislation, has been obtained. -Children of either sex; ages two to 16 years inclusive with a body weight between nine and 100 kg. However, only patients with a body weight of more than 12 kg will be allowed to participate in the PK section. -Neuropathic bladder secondary to known neurological disorder e.g. spina bifida . This includes patients who are performing clean intermittent catheterization CIC . -Elevated detrusor leak point pressures LPP 40 cm H2O confirmed by two measurements at baseline for patients who participated in Study 527.51 the baseline value from that study will be used .
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
-Clinically significant abnormalities found at, or before entering the study i.e., abnormal vital signs e.g., hypotension, abnormal ECG , as well as significant findings during the physical examination, as determined by the investigator. -Clinically significant conditions which, in the opinion of the investigator, may put patients 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. These clinically significant conditions include, but are not limited to, the following gastrointestinal, cardiovascular, hepatic, renal, hematologic, metabolic including uncontrolled diabetes mellitus , immunological, hormonal disorders, respiratory disease or cancer. -A history of relevant orthostatic hypotension, fainting spells or blackouts. Postural symptoms occurring e.g., light-headedness, dizziness, and fainting with or without a change in blood pressure and/or pulse rate within 6 weeks of screening visit, V1. -Patients with clinically significant laboratory abnormalities, or values greater than 2x times the upper limit of normal range. -Severe hydronephrosis greater than Grade 3, see Section 5.1.2 . A renal ultrasound performed within 3 months prior to entering the study will be acceptable as baseline assessment, if this assessment was performed while the patient was on stable medication. -Patients who have a history of bladder neck surgery, bladder augmentation or exteriorized bladder drainage procedure and those who had a surgical procedure under general anesthesia within the last 30 days prior to Visit 1 screening . -Patients who have a significant psychiatric disorder that prevents their ability to comply with the protocol. -Patients on drug therapy or non-drug therapy including electro-stimulation for their neuropathic bladder initiated during the 4 weeks prior to screening. -Patients taking cimetidine, ranitidine or warfarin. -All patients who have received Botulinum toxin A botox for urologic use within 6 months of the randomization visit. -Patients who have a history of allergy/hypersensitivity including drug and sulpha allergy which is deemed relevant to the trial as judged by the investigator. -Use of alpha-blockers e.g., terazosin, alfuzosin, doxazosin and tamsulosin within 30 days of screening visit, except for patients who participated in tamsulosin Study 527.51 who may have been randomized to tamsulosin. -Patients having a symptomatic urinary tract infection UTI at screening. Patients may be entered into the study after UTI has been treated and stabilized i.e., patients are no longer symptomatic . -Participation in another trial with an investigational drug within 1 month prior to administration or during the trial, excluding those patients who have participated in tamsulosin Study 527.51. -A positive pregnancy test or patients who are lactating. All female patients of child bearing potential, who are sexually active in the opinion of the investigator, must use two accepted methods of birth control. -All patients, whose parents and/or guardians in the investigator s opinion cannot understand the terms of the informed consent form and/or patient information form.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: This study is part of a clinical plan aimed to evaluate the efficacy and safety of tamsulosin hydrochloride in subjects up to 16 years with neurogenic bladder. The plan includes 2 studies, the present one 527.66 with a PK section and the pivotal phase III study 527.51. The main objective of this study is to evaluate the safety and efficacy of tamsulosin hydrochloride in children with neuropathic bladder for up to 12 months of treatment.;Secondary Objective: to characterise the pharmacokinetic PK and PK/pharmacodynamic PD profile of tamsulosin hydrochloride up to 14 days in children with neuropathic bladder;Primary end point(s): The primary endpoint is response defined as patients who achieve a detrusor leak point pressure LPP to less than 40 cm H2O based upon two confirmatory measurements at the end of treatment.
- Secondary Outcome Measures
Name Time Method