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

NCT02266524 | Completed Phase 1

• 1 other identifier: 527.49
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Urination Disorders

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (7)

• 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

Study Arms (4)

Tamsulosin hydrochloride, very low dose

EXPERIMENTAL

Drug: Tamsulosin hydrochloride, very low dose

Tamsulosin hydrochloride, low dose

EXPERIMENTAL

Drug: Tamsulosin hydrochloride, low dose

Tamsulosin hydrochloride, medium dose

EXPERIMENTAL

Drug: Tamsulosin hydrochloride, medium dose

Tamsulosin hydrochloride, high dose

EXPERIMENTAL

Drug: Tamsulosin hydrochloride, high dose

Interventions

Tamsulosin hydrochloride, very low dose DRUG

Also known as: Flomax®

Tamsulosin hydrochloride, very low dose

Tamsulosin hydrochloride, low dose DRUG

Also known as: Flomax®

Tamsulosin hydrochloride, low dose

Tamsulosin hydrochloride, medium dose DRUG

Also known as: Flomax®

Tamsulosin hydrochloride, medium dose

Tamsulosin hydrochloride, high dose DRUG

Also known as: Flomax®

Tamsulosin hydrochloride, high dose

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Urination Disorders

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 17, 2014
• Study Start: January 1, 2005
• Primary Completion: April 1, 2005
• Last Updated: October 17, 2014

Record last verified: 2014-10