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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

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). An LPP recorded while on stable medication and within 3 months prior to starting this study will be allowed as the baseline measurement if this recording is confirmed by two measurements.

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

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 Visit 1.
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.
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

Secondary Outcome Measures

Name	Time	Method

Related Trials

Boehringer Ingelheim España, S.A.

Updated 6/12/2012