PK/PD, Long-term Safety and Efficacy of Tamsulosin Treatment in Children With Neurogenic Bladder

Verified by: Astellas Pharma Inc, July 2009
First Received: June 19, 2006 | Last Updated: July 22, 2009 | Phase: Phase 2 | Start Date: April 2006
Overall Status: Completed | Estimated Enrollment: 143
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Aims of this study is to characterize the pharmacokinetic/pharmacodynamic profile and evaluate the safety, efficacy and tolerability, of tamsulosin hydrochloride as treatment in children with a neuropathic bladder, over the course of 12 months of active treatment...

Brief Summary

Official Title: “An Uncontrolled, Open-label, Titration, Long-term Safety (up to 12 Months) and Efficacy Study of Tamsulosin Hydrochloride in Children With Neuropathic Bladder, With a Randomized Pharmacokinetic Sub-study Investigating Low, Medium and High Dose Ranges.”

Aims of this study is to characterize the pharmacokinetic/pharmacodynamic profile and evaluate the safety, efficacy and tolerability, of tamsulosin hydrochloride as treatment in children with a neuropathic bladder, over the course of 12 months of active treatment.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: June 2009

Intervention(s) in this Clinical Trial

  • Drug: tamsulosin hydrochloride
    • oral

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1. Low dose group
  • Experimental: 2. Medium dose group
  • Experimental: 3. High dose group

Outcome Measures for this Clinical Trial

Primary Measures

  • Responder rate who achieves a decrease in their detrusor leak point pressure to less than 40cm H2O
    • Time Frame: End of treatment
      Safety Issue?: No

Secondary Measures

  • Improvement or stabilization of hydronephrosis and/or hydroureter base
    • Time Frame: End of treatment
      Safety Issue?: No
  • Assessment of pharmacokinetics parameters
    • Time Frame: 4 Weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Neuropathic bladder secondary to known neurological disorder
  • Elevated detrusor leak point pressures (LPP) ≥40 cm H2O confirmed by two measurements at baseline

Exclusion Criteria:

  • Clinically significant abnormalities as determined by the investigator
  • A history of relevant orthostatic hypotension, fainting spells or blackouts

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 16 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Astellas Pharma Inc Industry

Overall Clinical Trial Officials and Contacts

Use Central Contact Study Director Boehringer Ingelheim Pharmaceuticals  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00340704

Study ID Number: 527.66

ClinicalTrials.gov Identifier: NCT00340704

Health Authority: United States: Food and Drug Administration

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