Clinical trial NCT00340704: PK/PD, Long-term Safety and Efficacy of Tamsulosin Treatment in Children With Neurogenic Bladder
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bladder, Neurogenic
Keywords: tamsulosin
pediatric
neurogenic bladder
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-06-21
Enrollment: 143
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: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of LPP Responders for Group D-Denovo and Group D-527.51 Rollover
timeFrame: Group D-Denovo: Week 52. Group D-527.51 Rollover: Week 1, Week 2, Week 3 and Week 4 prior to dose administration and Week9 (optional), Week 13 (additional), Week 26 (optional) and Week 52 after drug administration.
measure: Number of LPP Responders at Each Visit Over Time (Classified by Last Value on Treatment) for Group D-527.51 Rollover.
timeFrame: Week 1 (Visit 3) , Week 2 (Visit 4) , Week 3 (Visit 5) and Week 4 (Visit 6) prior to dose administration and Week 9 (Visit 7) (optional), Week 13 (Visit 8) (additional), Week 26 (Visit 9) (optional) and Week 52 (Visit 11) after drug administration.
Secondary outcomes:
measure: Early Responders Who Maintained Their LPP Below 40 cm H2O During the Study for Group D-Denovo and Group D-527.51 Rollover
timeFrame: Week 1 to Week 52 (Time frame for all weeks are described study wise in the Description).
measure: Change From Baseline in LPP for Group D-527.51 Rollover
timeFrame: Baseline and week 1
measure: Percent Change From Baseline in LPP for Group D-527.51 Rollover
timeFrame: Baseline and Week 1
measure: Response Defined as Stabilization or Improvement of Hydroureter Measured by Renal Ultrasound Compared to Baseline for Group D-Denovo and Group D-527.51 Rollover
timeFrame: Group D-Denovo: Baseline and Week 52. Group D-527.51 Rollover: Baseline, Week 26 and Week 52.
measure: Response Defined as Stabilization or Improvement of Hydronephrosis Measured by Renal Ultrasound Compared to Baseline for Group D-Denovo and Group D-527.51 Rollover
timeFrame: Group D-Denovo: Baseline and Week 52. Group D-527.51 Rollover: Baseline, Week 26 and Week 52.
measure: LPP Response at Any Time During the Trial for Group D-Denovo and Group D-527.51 Rollover
timeFrame: Week 1 to Week 52 (described study wise in the Description).
measure: Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electrocardiogram (ECG), Laboratory Values,Urinalysis,Occurence of Adverse Events & Cognitive Testing for Group D-527.51 Rollover
timeFrame: From first drug administration until 28 days after last study drug administration, upto 395 days
measure: Number of Participants With Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic Testing, Electrocardiogram (ECG), Laboratory Values, Urinalysis, Occurence of Adverse Events and Cognitive Testing for Group D-Denovo
timeFrame: From first drug administration until 28 days after last study drug administration, upto 450 days
measure: Vision Testing for Group D-Denovo
timeFrame: Baseline, Week 26 and Week 52.
measure: Vision Testing for Group D-527.51 Rollover
timeFrame: Baseline and Week 52
measure: Cmax,1
timeFrame: -0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration.
measure: Tmax, 1
timeFrame: -0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration.
measure: Cmax, 1 ,DW ,Norm
timeFrame: -0.25h prior to dose and 2h, 4h, 6h and 8h after the drug administration.
measure: Cpre,ss
timeFrame: -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
measure: Cmax,ss
timeFrame: -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
measure: Cmax,ss, DW, Norm
timeFrame: -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
measure: Cmin,ss
timeFrame: -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
measure: Tmax,ss
timeFrame: -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
measure: AUCτ,ss
timeFrame: -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
measure: AUCτ ,ss ,DW ,Norm
timeFrame: -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
measure: λz,ss
timeFrame: -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
measure: t1/2,ss
timeFrame: -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
measure: MRTpo,ss
timeFrame: -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
measure: CL/F,ss,W,Norm
timeFrame: -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
measure: Vz/F,ss,W,Norm
timeFrame: -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
measure: RA,Cmax
timeFrame: -0.25h prior to dose and 2h, 4h, 6h, 8h, 10h, 24h and 33h after the drug administration.
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Springfield
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Shreveport
country: United States
state: Louisiana
city: St Louis
country: United States
state: Missouri
city: Buffalo
country: United States
state: New York
city: Lake Success
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: Oklahoma City
country: United States
state: Oklahoma
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Madison
country: United States
state: Wisconsin
city: Gent
country: Belgium
city: Santo Andre
country: Brazil
city: Sao Paulo
country: Brazil
city: Halifax
country: Canada
city: Montreal
country: Canada
city: Montreal
country: Canada
city: Toronto
country: Canada
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: Lucknow
country: India
city: Ludhiana
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: Seoul
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: