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Study to Evaluate the Efficacy and Safety of Tamsulosin in Children With Neurogenic Bladder

Primary Purpose

Bladder, Neurogenic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
tamsulosin hydrochloride
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder, Neurogenic focused on measuring tamsulosin, pediatric, neurogenic bladder

Eligibility Criteria

2 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Low dose

Medium dose

High dose

Arm Description

Participants received matching placebo to tamsulosin hydrochloride via opened capsules every day for 14 weeks

Participants received 0.001 - 0.002 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks

Participants received 0.002 - 0.004 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks

Participants received 0.004 - 0.008 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks

Outcomes

Primary Outcome Measures

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.
The primary endpoint was response to treatment defined as patients who decreased their detrusor leak point pressure (LPP) based upon two evaluations on the same day to less than 40 cm H2O at Week 14 (end of treatment). Detrusor leak point pressure (LPP) recorded in cm H2O was obtained using a standard urodynamic technique, a cystometrogram. On treatment (OT): Consist of all on treatment data. Observations measured ≤3 days of stopping treatment was considered as on treatment. Missing data in these analyses was not replaced or imputed.

Secondary Outcome Measures

Change From Baseline in LPP at Week 14 (End of Treatment)
Change from baseline in detrusor leak point pressure (LPP) at Week 14 (end of treatment) between each dose group and the placebo group was compared for the FAS-LPP.
Percentage Change From Baseline in LPP at Week 14 (End of Treatment)
Percent changes in detrusor leak point pressure (LPP) from baseline to the end of treatment at Week 14 between each dose group and the placebo group were compared for the FAS-LPP.
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
Hydronephrosis response was defined as stabilisation or improvement of hydronephrosis measured by renal ultrasound at the end of treatment when compared to baseline, based on ultrasound grading. The lower or same grade at end of treatment compared to baseline is considered an improvement or stabilization
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
Hydroureter response was defined as stabilisation or improvement based on change from baseline in the presence or absence of hydroureter at the end of treatment (Week 14). Response defined as stabilization or improvement of hydroureter measured by renal ultrasound compared to baseline by treatment group (Patients are classified according to the treatment they were taking at Week 14 or end of treatment) at Week 14.
Change From Baseline in Urine Volume at Week 14
Change in baseline urine volumes obtained by catheterisation as recorded in catheterisation diary at Week 14.
Change From Baseline in Number of Times Patient Was Wet at Catheterisation
Change from baseline in number of times patient was wet at time of catheterisation as recorded in catheterisation diary.
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.
Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing (blood pressure, pulse and respiratory rate), Electrocardiogram (ECG), Laboratory Values inclusive of hormonal assays, vision testing, Cognitive Testing, Occurrence of treatment emergent adverse events, Premature discontinuation of study drug due to AE and Urinalysis. Relevant findings or worsening of baseline conditions were reported as adverse events.
Post Void Residual Volume at Week 14
Median change from baseline to Week 14 in post void residual (mL) by study treatment.

Full Information

First Posted
November 20, 2008
Last Updated
September 29, 2015
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00796614
Brief Title
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder, Neurogenic
Keywords
tamsulosin, pediatric, neurogenic bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
231 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received matching placebo to tamsulosin hydrochloride via opened capsules every day for 14 weeks
Arm Title
Low dose
Arm Type
Experimental
Arm Description
Participants received 0.001 - 0.002 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks
Arm Title
Medium dose
Arm Type
Experimental
Arm Description
Participants received 0.002 - 0.004 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks
Arm Title
High dose
Arm Type
Experimental
Arm Description
Participants received 0.004 - 0.008 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks
Intervention Type
Drug
Intervention Name(s)
tamsulosin hydrochloride
Other Intervention Name(s)
Flomax, Omnic
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral
Primary Outcome Measure Information:
Title
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.
Description
The primary endpoint was response to treatment defined as patients who decreased their detrusor leak point pressure (LPP) based upon two evaluations on the same day to less than 40 cm H2O at Week 14 (end of treatment). Detrusor leak point pressure (LPP) recorded in cm H2O was obtained using a standard urodynamic technique, a cystometrogram. On treatment (OT): Consist of all on treatment data. Observations measured ≤3 days of stopping treatment was considered as on treatment. Missing data in these analyses was not replaced or imputed.
Time Frame
Week 14
Secondary Outcome Measure Information:
Title
Change From Baseline in LPP at Week 14 (End of Treatment)
Description
Change from baseline in detrusor leak point pressure (LPP) at Week 14 (end of treatment) between each dose group and the placebo group was compared for the FAS-LPP.
Time Frame
Baseline and Week 14
Title
Percentage Change From Baseline in LPP at Week 14 (End of Treatment)
Description
Percent changes in detrusor leak point pressure (LPP) from baseline to the end of treatment at Week 14 between each dose group and the placebo group were compared for the FAS-LPP.
Time Frame
Baseline and Week 14.
Title
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
Description
Hydronephrosis response was defined as stabilisation or improvement of hydronephrosis measured by renal ultrasound at the end of treatment when compared to baseline, based on ultrasound grading. The lower or same grade at end of treatment compared to baseline is considered an improvement or stabilization
Time Frame
Baseline and Week 14
Title
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
Description
Hydroureter response was defined as stabilisation or improvement based on change from baseline in the presence or absence of hydroureter at the end of treatment (Week 14). Response defined as stabilization or improvement of hydroureter measured by renal ultrasound compared to baseline by treatment group (Patients are classified according to the treatment they were taking at Week 14 or end of treatment) at Week 14.
Time Frame
Baseline and Week 14
Title
Change From Baseline in Urine Volume at Week 14
Description
Change in baseline urine volumes obtained by catheterisation as recorded in catheterisation diary at Week 14.
Time Frame
Baseline and Week 14
Title
Change From Baseline in Number of Times Patient Was Wet at Catheterisation
Description
Change from baseline in number of times patient was wet at time of catheterisation as recorded in catheterisation diary.
Time Frame
Baseline and Week 14
Title
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.
Description
Number of participants with Clinically Relevant Abnormalities for Physical Examination, Vital Signs/Orthostatic testing (blood pressure, pulse and respiratory rate), Electrocardiogram (ECG), Laboratory Values inclusive of hormonal assays, vision testing, Cognitive Testing, Occurrence of treatment emergent adverse events, Premature discontinuation of study drug due to AE and Urinalysis. Relevant findings or worsening of baseline conditions were reported as adverse events.
Time Frame
From first drug administration until 28 days after last study drug administration, upto 160 days
Title
Post Void Residual Volume at Week 14
Description
Median change from baseline to Week 14 in post void residual (mL) by study treatment.
Time Frame
Baseline and Week 14.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Facility Information:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States
City
Tarrytown
State/Province
New York
ZIP/Postal Code
10591
Country
United States
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Santo Andre
ZIP/Postal Code
09060-650
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
City
Berlin
ZIP/Postal Code
10115
Country
Germany
City
Deggendorf
ZIP/Postal Code
94469
Country
Germany
City
Essen
ZIP/Postal Code
45122
Country
Germany
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
City
Mainz
ZIP/Postal Code
55101
Country
Germany
City
Ahmedabad
ZIP/Postal Code
380-006
Country
India
City
Belgaum
ZIP/Postal Code
590-010
Country
India
City
Bengaluru
ZIP/Postal Code
560-010
Country
India
City
Hyderabaad
ZIP/Postal Code
500-029
Country
India
City
Kochin
ZIP/Postal Code
682-026
Country
India
City
Lucknow
ZIP/Postal Code
226-014
Country
India
City
Ludhiana
Country
India
City
Manipal
ZIP/Postal Code
576-104
Country
India
City
Mumbai
ZIP/Postal Code
400-008
Country
India
City
Nadiad
ZIP/Postal Code
387-001
Country
India
City
Nagpur
Country
India
City
New Delhi
ZIP/Postal Code
110-029
Country
India
City
Pune
ZIP/Postal Code
411-001
Country
India
City
Pune
ZIP/Postal Code
411-053
Country
India
City
Cagliari
ZIP/Postal Code
09134
Country
Italy
City
Firenze
ZIP/Postal Code
50139
Country
Italy
City
Roma
ZIP/Postal Code
00165
Country
Italy
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
City
In Cheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
City
Pusan
ZIP/Postal Code
602-739
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Leon
ZIP/Postal Code
37660
Country
Mexico
City
Puebla
ZIP/Postal Code
72190
Country
Mexico
City
Manila
ZIP/Postal Code
1000
Country
Philippines
City
Pasig City
ZIP/Postal Code
1604
Country
Philippines
City
Quezon City
ZIP/Postal Code
1104
Country
Philippines
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
194100
Country
Russian Federation
City
Bloemfontein
ZIP/Postal Code
9300
Country
South Africa
City
Cape Town
ZIP/Postal Code
7700
Country
South Africa
City
Johannesburg
Country
South Africa
City
Pretoria
ZIP/Postal Code
0028
Country
South Africa
City
Roodepoort
Country
South Africa
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Malaga
ZIP/Postal Code
29011
Country
Spain
City
Chernivtsy
ZIP/Postal Code
58002
Country
Ukraine

12. IPD Sharing Statement

Links:
URL
http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Flomax+Caps/Flomax.pdf
Description
Link to Prescribing Information
URL
http://trials.boehringer-ingelheim.com
Description
Related Info

Learn more about this trial

Study to Evaluate the Efficacy and Safety of Tamsulosin in Children With Neurogenic Bladder

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