AzTrials
AzTrials

Urination DisordersPhase 1NCT02266524

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

A Phase 1 study testing Tamsulosin hydrochloride, very low dose, Tamsulosin hydrochloride, low dose and Tamsulosin hydrochloride, medium dose in people with Urination Disorders, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To investigate pharmacokinetics, safety, and tolerability of tamsulosin hydrochloride in children with voiding disorders Read more about this study

Who is it for?
Ages 5 to 15 years
Conditions the study is for
Urination Disorders
What is being tested?
Tamsulosin hydrochloride, very low dose, Tamsulosin hydrochloride, low dose and Tamsulosin hydrochloride, medium dose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
No sites listed yet
Study dates
Jan 2005to Apr 2005
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

About this study

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

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

Being tested
Tamsulosin hydrochloride, very low dose, Tamsulosin hydrochloride, low dose, Tamsulosin hydrochloride, medium dose, Tamsulosin hydrochloride, high dose
Medical subject headings
Urination Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tamsulosin hydrochloride, very low doseDrug

    Also called Flomax®

  • Tamsulosin hydrochloride, low doseDrug

    Also called Flomax®

  • Tamsulosin hydrochloride, medium doseDrug

    Also called Flomax®

  • Tamsulosin hydrochloride, high doseDrug

    Also called Flomax®

Study groups in NCT02266524
Study groupRoleWhat they receive
Tamsulosin hydrochloride, very low doseExperimentalNot described
Receives: Drug: Tamsulosin hydrochloride, very low dose
Tamsulosin hydrochloride, low doseExperimentalNot described
Receives: Drug: Tamsulosin hydrochloride, low dose
Tamsulosin hydrochloride, medium doseExperimentalNot described
Receives: Drug: Tamsulosin hydrochloride, medium dose
Tamsulosin hydrochloride, high doseExperimentalNot described
Receives: Drug: Tamsulosin hydrochloride, high dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum concentration of the analyte in plasma (Cmax)

    Measured: Up to 26 hours after drug administration

  2. Time from dosing to maximum concentration of the analyte in plasma (tmax)

    Measured: Up to 26 hours after drug administration

  3. Area under the concentration-time curve of the analyte in plasma (AUC)

    Measured: Up to 26 hours after drug administration

  4. 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-∞)

    Measured: Up to 26 hours after drug administration

  5. Terminal rate constant of the analyte in plasma (λz)

    Measured: Up to 26 hours after drug administration

  6. Terminal half-life of the analyte in plasma (t1/2)

    Measured: Up to 26 hours after drug administration

  7. Mean residence time of the analyte in the body after po administration (MRTpo)

    Measured: Up to 26 hours after drug administration

  8. Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)

    Measured: Up to 26 hours after drug administration

  9. Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)

    Measured: Up to 26 hours after drug administration

  10. Weight-normalized Cmax

    Measured: Up to 26 hours after drug administration

  11. Weight-normalized AUC0-∞

    Measured: Up to 26 hours after drug administration

  12. 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)

    Measured: Up to 26 hours after drug administration

Secondary outcomes (7)

  1. Number of patients with clinically relevant changes in physical examination

    Measured: Pre-dose, up to 26 hours after drug administration

  2. Number of patients with clinically relevant changes in vital signs (blood pressure, pulse rate, respiratory rate)

    Measured: Pre-dose, up to 26 hours after drug administration

  3. Number of patients with clinically relevant changes from baseline in orthostatic test

    Measured: Pre-dose and 4 hours after drug administration

  4. Number of patients with clinically relevant changes in 12-lead ECG

    Measured: Pre-dose, up to 26 hours after drug administration

  5. Number of patients with clinically relevant changes from baseline in laboratory tests

    Measured: Pre-dose and 26 hours after drug administration

  6. Number of patients with adverse events

    Measured: Up to 7 days after drug administration

  7. Global assessment of tolerability by the investigator on a 5-point rating scale

    Measured: 26 hours after drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2014 (estimated)
  2. Study startJan 2005
  3. Primary completionApr 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02266524
Sponsor's protocol ID
527.49
Status last verified
Oct 2014
First submitted
16 Oct 2014
Last updated
17 Oct 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tamsulosin hydrochloride, very low dose, Tamsulosin hydrochloride, low dose and Tamsulosin hydrochloride, medium dose in people with Urination Disorders, run by Boehringer Ingelheim.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum concentration of the analyte in plasma (Cmax) (time frame: Up to 26 hours after drug administration). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02266524.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in