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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Urination Disorders

Treatments: Drug: Tamsulosin hydrochloride, very low dose; Drug: Tamsulosin hydrochloride, low dose; Drug: Tamsulosin hydrochloride, high dose; Drug: Tamsulosin hydrochloride, medium dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02266524

527.49

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 5 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

Tamsulosin hydrochloride, very low dose

Experimental group

Treatment:

Drug: Tamsulosin hydrochloride, very low dose

Tamsulosin hydrochloride, low dose

Experimental group

Treatment:

Drug: Tamsulosin hydrochloride, low dose

Tamsulosin hydrochloride, medium dose

Experimental group

Treatment:

Drug: Tamsulosin hydrochloride, medium dose

Tamsulosin hydrochloride, high dose

Experimental group

Treatment:

Drug: Tamsulosin hydrochloride, high dose