Clinical trial NCT00796614: Study to Evaluate the Efficacy and Safety of Tamsulosin in Children With Neurogenic Bladder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Bladder, Neurogenic
Keywords: tamsulosin
pediatric
neurogenic bladder
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-11-24
Enrollment: 231
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: Week 14
Secondary outcomes:
measure: Change From Baseline in LPP at Week 14 (End of Treatment)
timeFrame: Baseline and Week 14
measure: Percentage Change From Baseline in LPP at Week 14 (End of Treatment)
timeFrame: Baseline and Week 14.
measure: 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
timeFrame: Baseline and Week 14
measure: 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
timeFrame: Baseline and Week 14
measure: Change From Baseline in Urine Volume at Week 14
timeFrame: Baseline and Week 14
measure: Change From Baseline in Number of Times Patient Was Wet at Catheterisation
timeFrame: Baseline and Week 14
measure: 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.
timeFrame: From first drug administration until 28 days after last study drug administration, upto 160 days
measure: Post Void Residual Volume at Week 14
timeFrame: Baseline and Week 14.
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Tampa
country: United States
state: Florida
city: St Louis
country: United States
state: Missouri
city: Buffalo
country: United States
state: New York
city: Tarrytown
country: United States
state: New York
city: Winston Salem
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Gent
country: Belgium
city: Santo Andre
country: Brazil
city: Sao Paulo
country: Brazil
city: Berlin
country: Germany
city: Deggendorf
country: Germany
city: Essen
country: Germany
city: Hamburg
country: Germany
city: Mainz
country: Germany
city: Ahmedabad
country: India
city: Belgaum
country: India
city: Bengaluru
country: India
city: Hyderabaad
country: India
city: Kochin
country: India
city: Lucknow
country: India
city: Ludhiana
country: India
city: Manipal
country: India
city: Mumbai
country: India
city: Nadiad
country: India
city: Nagpur
country: India
city: New Delhi
country: India
city: Pune
country: India
city: Pune
country: India
city: Cagliari
country: Italy
city: Firenze
country: Italy
city: Roma
country: Italy
city: Gwangju
country: Korea, Republic of
city: In Cheon
country: Korea, Republic of
city: Pusan
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Leon
country: Mexico
city: Puebla
country: Mexico
city: Manila
country: Philippines
city: Pasig City
country: Philippines
city: Quezon City
country: Philippines
city: Moscow
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Bloemfontein
country: South Africa
city: Cape Town
country: South Africa
city: Johannesburg
country: South Africa
city: Pretoria
country: South Africa
city: Roodepoort
country: South Africa
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Chernivtsy
country: Ukraine
Study officials:
References: