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

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

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

Study Overview

• Status: Completed
• Conditions: Bladder, Neurogenic
• Intervention / Treatment: Drug: Placebo; Drug: tamsulosin hydrochloride

• Study Type: Interventional
• Enrollment (Actual): 231
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
• Brazil
  • Santo Andre, Brazil, 09060-650
  • Sao Paulo, Brazil, 05403-000
• Germany
  • Berlin, Germany, 10115
  • Deggendorf, Germany, 94469
  • Essen, Germany, 45122
  • Hamburg, Germany, 22763
  • Mainz, Germany, 55101
• India
  • Ahmedabad, India, 380-006
  • Belgaum, India, 590-010
  • Bengaluru, India, 560-010
  • Hyderabaad, India, 500-029
  • Kochin, India, 682-026
  • Lucknow, India, 226-014
  • Ludhiana, India
  • Manipal, India, 576-104
  • Mumbai, India, 400-008
  • Nadiad, India, 387-001
  • Nagpur, India
  • New Delhi, India, 110-029
  • Pune, India, 411-001
  • Pune, India, 411-053
• Italy
  • Cagliari, Italy, 09134
  • Firenze, Italy, 50139
  • Roma, Italy, 00165
• Korea, Republic of
  • Gwangju, Korea, Republic of, 501-757
  • In Cheon, Korea, Republic of, 400-711
  • Pusan, Korea, Republic of, 602-739
  • Seoul, Korea, Republic of
• Mexico
  • Leon, Mexico, 37660
  • Puebla, Mexico, 72190
• Philippines
  • Manila, Philippines, 1000
  • Pasig City, Philippines, 1604
  • Quezon City, Philippines, 1104
• Russian Federation
  • Moscow, Russian Federation, 119991
  • St Petersburg, Russian Federation, 194100
• South Africa
  • Bloemfontein, South Africa, 9300
  • Cape Town, South Africa, 7700
  • Johannesburg, South Africa
  • Pretoria, South Africa, 0028
  • Roodepoort, South Africa
• Spain
  • Barcelona, Spain, 08025
  • Madrid, Spain, 28046
  • Malaga, Spain, 29011
• Ukraine
  • Chernivtsy, Ukraine, 58002
• United States
  • California
    • Los Angeles, California, United States, 90027
  • Florida
    • Tampa, Florida, United States, 33614
  • Missouri
    • St Louis, Missouri, United States, 63110
  • New York
    • Buffalo, New York, United States, 14222
    • Tarrytown, New York, United States, 10591
  • North Carolina
    • Winston Salem, North Carolina, United States, 27157
  • Ohio
    • Akron, Ohio, United States, 44308

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 14
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.	Baseline and Week 14.
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	Baseline and Week 14
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.	Baseline and 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.	Baseline and 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.	Baseline and Week 14
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.	From first drug administration until 28 days after last study drug administration, upto 160 days
Post Void Residual Volume at Week 14	Median change from baseline to Week 14 in post void residual (mL) by study treatment.	Baseline and Week 14.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info
• Link to Prescribing Information

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (ACTUAL): February 1, 2009
• Study Completion (ACTUAL): February 1, 2009

Study Registration Dates

• First Submitted: November 20, 2008
• First Submitted That Met QC Criteria: November 20, 2008
• First Posted (ESTIMATE): November 24, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 29, 2015
• Last Update Submitted That Met QC Criteria: September 29, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: pediatric; tamsulosin; neurogenic bladder
• Additional Relevant MeSH Terms: Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Urinary Bladder, Neurogenic; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin
• Other Study ID Numbers: 527.51