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Study to Evaluate the Efficacy and Safety of Tamsulosin in Children With Neurogenic Bladder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00796614
First received: November 20, 2008
Last updated: September 29, 2015
Last verified: September 2015
  Purpose
Aim of this study is to evaluate the efficacy and safety of a range of doses of tamsulosin hydrochloride as treatment in children with an elevated detrusor leak point pressure associated with a known neurological deficit

Condition Intervention Phase
Bladder, Neurogenic
Drug: tamsulosin hydrochloride
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase IIb/III, Multi-centre, Double-blind, Randomised, Placebo-controlled, Dose Ranging Study of Tamsulosin Hydrochloride (Low, Medium and High Dose) as Treatment in Children With Neuropathic Bladder for Three Months

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Response to Treatment Defined as Patients Who Decrease Their Detrusor Leak Point Pressure (LPP) to <40 cm H2O Based Upon Two Evaluations on the Same Day. [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
    The primary endpoint was response to treatment defined as patients who decreased their detrusor leak point pressure (LPP) based upon two evaluations on the same day to less than 40 cm H2O at Week 14 (end of treatment). Detrusor leak point pressure (LPP) recorded in cm H2O was obtained using a standard urodynamic technique, a cystometrogram. On treatment (OT): Consist of all on treatment data. Observations measured ≤3 days of stopping treatment was considered as on treatment. Missing data in these analyses was not replaced or imputed.


Secondary Outcome Measures:
  • Change From Baseline in LPP at Week 14 (End of Treatment) [ Time Frame: Baseline and Week 14 ] [ Designated as safety issue: No ]
    Change from baseline in detrusor leak point pressure (LPP) at Week 14 (end of treatment) between each dose group and the placebo group was compared for the FAS-LPP.

  • Percentage Change From Baseline in LPP at Week 14 (End of Treatment) [ Time Frame: Baseline and Week 14. ] [ Designated as safety issue: No ]
    Percent changes in detrusor leak point pressure (LPP) from baseline to the end of treatment at Week 14 between each dose group and the placebo group were compared for the FAS-LPP.

  • Response With Regard to Hydronephrosis Was Defined as Improvement or Stabilisation Based Upon the Renal Ultrasound Grading at Week 14 (End of Treatment) Compared to Baseline [ Time Frame: Baseline and Week 14 ] [ Designated as safety issue: No ]

    Hydronephrosis response was defined as stabilisation or improvement of hydronephrosis measured by renal ultrasound at the end of treatment when compared to baseline, based on ultrasound grading.

    The lower or same grade at end of treatment compared to baseline is considered an improvement or stabilization


  • Response With Regard to Hydroureter Was Defined as Improvement or Stabilisation Based Upon the Renal Ultrasound at Week 14 (End of Treatment) Compared to Baseline [ Time Frame: Baseline and Week 14 ] [ Designated as safety issue: No ]

    Hydroureter response was defined as stabilisation or improvement based on change from baseline in the presence or absence of hydroureter at the end of treatment (Week 14).

    Response defined as stabilization or improvement of hydroureter measured by renal ultrasound compared to baseline by treatment group (Patients are classified according to the treatment they were taking at Week 14 or end of treatment) at Week 14.


  • Change From Baseline in Urine Volume at Week 14 [ Time Frame: Baseline and Week 14 ] [ Designated as safety issue: No ]
    Change in baseline urine volumes obtained by catheterisation as recorded in catheterisation diary at Week 14.

  • Change From Baseline in Number of Times Patient Was Wet at Catheterisation [ Time Frame: Baseline and Week 14 ] [ Designated as safety issue: No ]
    Change from baseline in number of times patient was wet at time of catheterisation as recorded in catheterisation diary.

  • Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electorocardiogram (ECG), Laboratory Values, Urinalysis, Treatment Emergent AE's and Cognitive Testing. [ Time Frame: From first drug administration until 28 days after last study drug administration, upto 160 days ] [ Designated as safety issue: No ]

    Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing (blood pressure, pulse and respiratory rate), Electrocardiogram (ECG), Laboratory Values inclusive of hormonal assays, vision testing, Cognitive Testing, Occurrence of treatment emergent adverse events, Premature discontinuation of study drug due to AE and Urinalysis.

    Relevant findings or worsening of baseline conditions were reported as adverse events.


  • Post Void Residual Volume at Week 14 [ Time Frame: Baseline and Week 14. ] [ Designated as safety issue: No ]
    Median change from baseline to Week 14 in post void residual (mL) by study treatment.


Enrollment: 231
Study Start Date: January 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Participants received matching placebo to tamsulosin hydrochloride via opened capsules every day for 14 weeks
Drug: Placebo
Oral
Experimental: Low dose
Participants received 0.001 - 0.002 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks
Drug: tamsulosin hydrochloride
Oral
Other Names:
  • Flomax
  • Omnic
Experimental: Medium dose
Participants received 0.002 - 0.004 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks
Drug: tamsulosin hydrochloride
Oral
Other Names:
  • Flomax
  • Omnic
Experimental: High dose
Participants received 0.004 - 0.008 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks
Drug: tamsulosin hydrochloride
Oral
Other Names:
  • Flomax
  • Omnic

  Eligibility

Ages Eligible for Study:   2 Years to 16 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Neuropathic bladder secondary to a known neurologic deficit (e.g. spina bifida)
  • Elevated detrusor leak point pressures (LPP) ≥40 cm H2O confirmed by two measurements

Exclusion Criteria:

  • Clinically significant abnormalities as determined by the investigator
  • A history of relevant orthostatic hypotension, fainting spells or blackouts
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796614

  Show 52 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
  More Information

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00796614     History of Changes
Other Study ID Numbers: 527.51 
Study First Received: November 20, 2008
Results First Received: August 6, 2012
Last Updated: September 29, 2015
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: Ministry of Health
Canada: Canadian Institutes of Health Research
Germany: Federal Institute for Drugs and Medical Devices
India: Ministry of Health
Italy: Ministry of Health
Korea: Food and Drug Administration
Mexico: Ministry of Health
Philippines: Department of Health
Russia: Ministry of Health of the Russian Federation
South Africa: Department of Health
Spain: Ministry of Health
Ukraine: Ministry of Health

Keywords provided by Boehringer Ingelheim:
tamsulosin
pediatric
neurogenic bladder

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents

ClinicalTrials.gov processed this record on December 02, 2016