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

Primary Purpose

Urination Disorders

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Tamsulosin hydrochloride, very low dose
Tamsulosin hydrochloride, low dose
Tamsulosin hydrochloride, medium dose
Tamsulosin hydrochloride, high dose
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urination Disorders

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Tamsulosin hydrochloride, very low dose

    Tamsulosin hydrochloride, low dose

    Tamsulosin hydrochloride, medium dose

    Tamsulosin hydrochloride, high dose

    Arm Description

    Outcomes

    Primary Outcome Measures

    Maximum concentration of the analyte in plasma (Cmax)
    Time from dosing to maximum concentration of the analyte in plasma (tmax)
    Area under the concentration-time curve of the analyte in plasma (AUC)
    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-∞)
    Terminal rate constant of the analyte in plasma (λz)
    Terminal half-life of the analyte in plasma (t1/2)
    Mean residence time of the analyte in the body after po administration (MRTpo)
    Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)
    Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
    Weight-normalized Cmax
    Weight-normalized AUC0-∞
    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)

    Secondary Outcome Measures

    Number of patients with clinically relevant changes in physical examination
    Number of patients with clinically relevant changes in vital signs (blood pressure, pulse rate, respiratory rate)
    Number of patients with clinically relevant changes from baseline in orthostatic test
    Number of patients with clinically relevant changes in 12-lead ECG
    Number of patients with clinically relevant changes from baseline in laboratory tests
    Number of patients with adverse events
    Global assessment of tolerability by the investigator on a 5-point rating scale

    Full Information

    First Posted
    October 16, 2014
    Last Updated
    October 16, 2014
    Sponsor
    Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02266524
    Brief Title
    Pharmacokinetics, Safety and Tolerability of Tamsulosin Hydrochloride in Children With Voiding Disorders
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2005 (undefined)
    Primary Completion Date
    April 2005 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boehringer Ingelheim

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urination Disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tamsulosin hydrochloride, very low dose
    Arm Type
    Experimental
    Arm Title
    Tamsulosin hydrochloride, low dose
    Arm Type
    Experimental
    Arm Title
    Tamsulosin hydrochloride, medium dose
    Arm Type
    Experimental
    Arm Title
    Tamsulosin hydrochloride, high dose
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Tamsulosin hydrochloride, very low dose
    Other Intervention Name(s)
    Flomax®
    Intervention Type
    Drug
    Intervention Name(s)
    Tamsulosin hydrochloride, low dose
    Other Intervention Name(s)
    Flomax®
    Intervention Type
    Drug
    Intervention Name(s)
    Tamsulosin hydrochloride, medium dose
    Other Intervention Name(s)
    Flomax®
    Intervention Type
    Drug
    Intervention Name(s)
    Tamsulosin hydrochloride, high dose
    Other Intervention Name(s)
    Flomax®
    Primary Outcome Measure Information:
    Title
    Maximum concentration of the analyte in plasma (Cmax)
    Time Frame
    Up to 26 hours after drug administration
    Title
    Time from dosing to maximum concentration of the analyte in plasma (tmax)
    Time Frame
    Up to 26 hours after drug administration
    Title
    Area under the concentration-time curve of the analyte in plasma (AUC)
    Time Frame
    Up to 26 hours after drug administration
    Title
    Percentage of the AUC0-∞ that is obtained by extrapolation (%AUCtz-∞)
    Description
    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-∞)
    Time Frame
    Up to 26 hours after drug administration
    Title
    Terminal rate constant of the analyte in plasma (λz)
    Time Frame
    Up to 26 hours after drug administration
    Title
    Terminal half-life of the analyte in plasma (t1/2)
    Time Frame
    Up to 26 hours after drug administration
    Title
    Mean residence time of the analyte in the body after po administration (MRTpo)
    Time Frame
    Up to 26 hours after drug administration
    Title
    Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)
    Time Frame
    Up to 26 hours after drug administration
    Title
    Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
    Time Frame
    Up to 26 hours after drug administration
    Title
    Weight-normalized Cmax
    Time Frame
    Up to 26 hours after drug administration
    Title
    Weight-normalized AUC0-∞
    Time Frame
    Up to 26 hours after drug administration
    Title
    Weight-normalized (AUC0-tz)
    Description
    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)
    Time Frame
    Up to 26 hours after drug administration
    Secondary Outcome Measure Information:
    Title
    Number of patients with clinically relevant changes in physical examination
    Time Frame
    Pre-dose, up to 26 hours after drug administration
    Title
    Number of patients with clinically relevant changes in vital signs (blood pressure, pulse rate, respiratory rate)
    Time Frame
    Pre-dose, up to 26 hours after drug administration
    Title
    Number of patients with clinically relevant changes from baseline in orthostatic test
    Time Frame
    Pre-dose and 4 hours after drug administration
    Title
    Number of patients with clinically relevant changes in 12-lead ECG
    Time Frame
    Pre-dose, up to 26 hours after drug administration
    Title
    Number of patients with clinically relevant changes from baseline in laboratory tests
    Time Frame
    Pre-dose and 26 hours after drug administration
    Title
    Number of patients with adverse events
    Time Frame
    Up to 7 days after drug administration
    Title
    Global assessment of tolerability by the investigator on a 5-point rating scale
    Time Frame
    26 hours after drug administration

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Links:
    URL
    http://trials.boehringer-ingelheim.com
    Description
    Related Info

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

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