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

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...

Date First Received: June 19, 2006

Last Updated: June 26, 2007

Verified by: Astellas Pharma Inc, June 2007

Clinical Trial Phase: Phase 2 | Start Date: 

Overall Status: Recruiting

Brief Summary

Condition Keyword(s):

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: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

  • Drug: tamsulosin hydrochloride

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Neuropathic bladder secondary to myelodysplasia (including transverse myelopathy, myelomeningocele, sacral agenesis, tethered cord syndrome, etc), spinal cord tumor or spinal cord trauma.
  • Elevated detrusor leak point pressures (LPP) ≥40 cm H2O confirmed by two measurements at baseline

Exclusion Criteria:

    -

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 Sponsor Information

Lead Sponsor: Astellas Pharma Inc

Overall Clinical Trial Officials and Contacts

Use Central Contact Study Director Boehringer Ingelheim Pharmaceuticals  

Overall Contact: Boehringer Ingelheim Pharmaceuticals, Inc. (203) 798-4314 jmckay@rdg.boehringer-ingelheim.com

Additional Information

Information obtained from ClinicalTrials.gov on October 10, 2008

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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