Pharmacokinetics, Safety and Tolerability of Tamsulosin Hydrochloride in Children With Voiding Disorders

Pharmacokinetics, Safety and Tolerability of Single Oral Doses (0.1, 0.2, 0.4 and 0.8 mg) of Tamsulosin Hydrochloride in Children With Voiding Disorders

To investigate pharmacokinetics, safety, and tolerability of tamsulosin hydrochloride in children with voiding disorders

Study Overview

• Status: Completed
• Conditions: Urination Disorders
• Intervention / Treatment: Drug: Tamsulosin hydrochloride, very low dose; Drug: Tamsulosin hydrochloride, low dose; Drug: Tamsulosin hydrochloride, medium dose; Drug: Tamsulosin hydrochloride, high dose

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Boys and girls with (or a history of) voiding disorders
• Age: 5 to 15 years
• Body weight and height ≥ 5 % and ≤95 % of normal using nomograms
• 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 good clinical practice (GCP) and the local legislation, has been obtained

Exclusion Criteria:

• Clinically significant abnormalities found at, or before randomization at Visit 2 [i.e., abnormal: vital signs (e.g., hypotension), ECGs, as well as significant findings during the physical examination], as determined by the investigator
• Clinically relevant conditions including, but not limited to, the following: gastrointestinal, cardiovascular (e.g., subjects that fall above the 90th percentile according to the blood pressure nomogram in the ISF), hepatic, renal, hematologic, metabolic (including diabetes mellitus), immunological, hormonal disorders, respiratory disease or cancer
• Subjects who had surgery within the last 30 days
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• Subjects that have a neurological impairment or psychiatric disorder that prevents their comprehension of consent and their ability to comply with the protocol
• History of relevant orthostatic hypotension, fainting spells or blackouts. Postdural symptoms occurring (e.g., lightheadedness, dizziness, and fainting) with or without a change in blood pressure and / or pulse rate within 6 weeks of Visit 2
• Relevant acute infections, especially with regards to urinary tract infections or active genitourinary infection
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Subjects with known hypersensitivity to FLOMAX® (tamsulosin hydrochloride) or other alpha-blockers
• Use of medications classified as cytochrome P450 3A4 (CYP3A4) inhibitors and inducers within 10 days prior to administration of trial drug
• Intake of drugs with a long half-life (> 24 hours) within less than 10 half-lives of the respective drug prior to administration
• Participation in another trial with an investigational drug within 1 month prior to administration or during the trial
• Inability to comply with dietary regimen of study center
• Pregnancy or subjects that are breast feeding
• All subjects parents and guardians in the investigator's opinion who cannot understand the terms of the informed consent form and subject information

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tamsulosin hydrochloride, very low dose	Drug: Tamsulosin hydrochloride, very low dose; Other Names: Flomax®
Experimental: Tamsulosin hydrochloride, low dose	Drug: Tamsulosin hydrochloride, low dose; Other Names: Flomax®
Experimental: Tamsulosin hydrochloride, medium dose	Drug: Tamsulosin hydrochloride, medium dose; Other Names: Flomax®
Experimental: Tamsulosin hydrochloride, high dose	Drug: Tamsulosin hydrochloride, high dose; Other Names: Flomax®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum concentration of the analyte in plasma (Cmax)		Up to 26 hours after drug administration
Time from dosing to maximum concentration of the analyte in plasma (tmax)		Up to 26 hours after drug administration
Area under the concentration-time curve of the analyte in plasma (AUC)		Up to 26 hours after drug administration
Percentage of the AUC0-∞ that is obtained by extrapolation (%AUCtz-∞)	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after single-dose administration (AUC0-∞)	Up to 26 hours after drug administration
Terminal rate constant of the analyte in plasma (λz)		Up to 26 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)		Up to 26 hours after drug administration
Mean residence time of the analyte in the body after po administration (MRTpo)		Up to 26 hours after drug administration
Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)		Up to 26 hours after drug administration
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)		Up to 26 hours after drug administration
Weight-normalized Cmax		Up to 26 hours after drug administration
Weight-normalized AUC0-∞		Up to 26 hours after drug administration
Weight-normalized (AUC0-tz)	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration after single-dose administration (AUC0-tz)	Up to 26 hours after drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients with clinically relevant changes in physical examination	Pre-dose, up to 26 hours after drug administration
Number of patients with clinically relevant changes in vital signs (blood pressure, pulse rate, respiratory rate)	Pre-dose, up to 26 hours after drug administration
Number of patients with clinically relevant changes from baseline in orthostatic test	Pre-dose and 4 hours after drug administration
Number of patients with clinically relevant changes in 12-lead ECG	Pre-dose, up to 26 hours after drug administration
Number of patients with clinically relevant changes from baseline in laboratory tests	Pre-dose and 26 hours after drug administration
Number of patients with adverse events	Up to 7 days after drug administration
Global assessment of tolerability by the investigator on a 5-point rating scale	26 hours after drug administration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): April 1, 2005

Study Registration Dates

• First Submitted: October 16, 2014
• First Submitted That Met QC Criteria: October 16, 2014
• First Posted (Estimate): October 17, 2014

Study Record Updates

• Last Update Posted (Estimate): October 17, 2014
• Last Update Submitted That Met QC Criteria: October 16, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin
• Other Study ID Numbers: 527.49