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

Urination Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02266524
• Other study ID #: 527.49
• Status: Completed
• Phase: Phase 1
• First received: October 16, 2014
• Last updated: October 16, 2014
• Start date: January 2005

Study information

• Verified date: October 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 15 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urination Disorders

Intervention

Drug:
• Tamsulosin hydrochloride, very low dose

• Tamsulosin hydrochloride, low dose

• Tamsulosin hydrochloride, medium dose

• Tamsulosin hydrochloride, high dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum concentration of the analyte in plasma (Cmax)		Up to 26 hours after drug administration	No
Primary	Time from dosing to maximum concentration of the analyte in plasma (tmax)		Up to 26 hours after drug administration	No
Primary	Area under the concentration-time curve of the analyte in plasma (AUC)		Up to 26 hours after drug administration	No
Primary	Percentage of the AUC0-8 that is obtained by extrapolation (%AUCtz-8)	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after single-dose administration (AUC0-8)	Up to 26 hours after drug administration	No
Primary	Terminal rate constant of the analyte in plasma (?z)		Up to 26 hours after drug administration	No
Primary	Terminal half-life of the analyte in plasma (t1/2)		Up to 26 hours after drug administration	No
Primary	Mean residence time of the analyte in the body after po administration (MRTpo)		Up to 26 hours after drug administration	No
Primary	Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)		Up to 26 hours after drug administration	No
Primary	Apparent volume of distribution during the terminal phase ?z following an extravascular dose (Vz/F)		Up to 26 hours after drug administration	No
Primary	Weight-normalized Cmax		Up to 26 hours after drug administration	No
Primary	Weight-normalized AUC0-8		Up to 26 hours after drug administration	No
Primary	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	No
Secondary	Number of patients with clinically relevant changes in physical examination		Pre-dose, up to 26 hours after drug administration	No
Secondary	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	No
Secondary	Number of patients with clinically relevant changes from baseline in orthostatic test		Pre-dose and 4 hours after drug administration	No
Secondary	Number of patients with clinically relevant changes in 12-lead ECG		Pre-dose, up to 26 hours after drug administration	No
Secondary	Number of patients with clinically relevant changes from baseline in laboratory tests		Pre-dose and 26 hours after drug administration	No
Secondary	Number of patients with adverse events		Up to 7 days after drug administration	No
Secondary	Global assessment of tolerability by the investigator on a 5-point rating scale		26 hours after drug administration	No

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