Study to Evaluate the Efficacy and Safety of Tamsulosin in Children With Neurogenic Bladder - Full Text View

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:

Drug Information available for: Tamsulosin Tamsulosin hydrochloride

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Percentage of Participants Who Responded to Treatment [ Time Frame: Baseline and end of treatment (Week 14) ] [ Designated as safety issue: No ]
Detrusor leak point pressure (LPP) recorded in cm H2O was obtained using a standard urodynamic technique, a cystometrogram. Urodynamic testing was performed at least two times during the scheduled visit to determine consistent results. A responder is defined as a patient with two LPP measurements <40 cm H2O based on two confirmatory values at the same visit, or a patient with only 1 LPP measurement and the measurement is <40 cm H2O. Patients with two LPP measurements ≥40 cm H2O or with two LPP measurements where one is ≥40 cm H2O and the other is <40 cm H2O were considered non-responders.

Secondary Outcome Measures:

Change From Baseline in Detrusor Leak Point Pressure [ Time Frame: Baseline and end of treatment (Week 14) ] [ Designated as safety issue: No ]
Detrusor leak point pressure (LPP) was measured using a standard urodynamic technique, a cystometrogram. Urodynamic testing was performed at least two times during the scheduled visit to determine consistent results. The actual value for the detrusor leak point pressure determined at each visit was the mean of all measurements obtained at that visit.
Percentage of Participants With a Hydroureter Response [ Time Frame: Baseline and end of treatment (Week 14) ] [ Designated as safety issue: No ]
Hydroureter response was defined as improvement or stabilization based upon a change in the presence or absence of hydroureter at the end of treatment compared to baseline. Ultrasound examination of each ureter was conducted to establish the presence or absence of hydroureter.
Percentage of Participants With a Hydronephrosis Response [ Time Frame: Baseline and end of treatment (Week 14) ] [ Designated as safety issue: No ]
Hydronephrosis response was defined as improvement or stabilization based upon the renal ultrasound grading at the end of treatment compared to baseline. Patients were considered as having improvement or stabilization of their hydronephrosis if their grade at the end of treatment visit was the same or lower than the grade at baseline. The severity of the hydronephrosis was graded on a scale from 0 (no hydronephrosis, central renal complex intact) to 4 (dilation of pelvis and calices, calices may appear convex; thin renal parenchyma).
Change From Baseline in Urine Volume [ Time Frame: Baseline and end of treatment (Week 14) ] [ Designated as safety issue: No ]
For all patients who participated in a catheterization treatment regimen, a diary was kept of the urine volumes that were collected during catheterization. This diary was completed for the 48 hour period prior to each clinic visit.
Change From Baseline in Number of Times Patient Wet at Catheterization [ Time Frame: Baseline and end of treatment (Week 14) ] [ Designated as safety issue: No ]
For all patients who participated in a catheterization treatment regimen, the patient or the patient's caregiver recorded in the catheterization diary whether the patient was dry or wet at the time of catheterization. This diary was completed for the 48 hour period prior to each clinic visit.
Safety Assessed by Physical Examination, Vital Signs, Orthostatic Testing, ECG, Laboratory Values and Adverse Events (AEs) [ Time Frame: From the first dose of study medication until 28-days after the end of treatment ] [ Designated as safety issue: No ]
The investigator assessed all AEs for relationship to study drug. A severe AE is an event that was incapacitating or caused inability to work or perform usual activity. An AE is serious if it results in: Death; is life-threatening; persistent or significant disability; requires or prolongs hospitalization; a congenital anomaly / birth defect; requires medical intervention to prevent one of the above. Significant was defined according to ICH E3 Guidelines: adverse events marked as hematological or other laboratory abnormalities (but not serious) or leading to intervention.

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
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

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

Show 52 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Director:

Use Central Contact

Astellas Pharma Inc

More Information

Additional Information:

Link to Prescribing Information This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Astellas Pharma Inc
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:	August 6, 2012
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 Astellas Pharma Inc:

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
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013