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
About this trial
This is an interventional treatment trial for Urination Disorders
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
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
NCT ID
NCT02266524
First Posted
October 16, 2014
Last Updated
October 16, 2014
Sponsor
Boehringer Ingelheim
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
Learn more about this trial
Pharmacokinetics, Safety and Tolerability of Tamsulosin Hydrochloride in Children With Voiding Disorders
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