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

Bladder, Neurogenic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00796614
• Other study ID #: 527.51
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 20, 2008
• Last updated: September 29, 2015
• Start date: January 2008
• Est. completion date: February 2009

Study information

• Verified date: September 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsBrazil: Ministry of HealthCanada: Canadian Institutes of Health ResearchGermany: Federal Institute for Drugs and Medical DevicesIndia: Ministry of HealthItaly: Ministry of HealthKorea: Food and Drug AdministrationMexico: Ministry of HealthPhilippines: Department of HealthRussia: Ministry of Health of the Russian FederationSouth Africa: Department of HealthSpain: Ministry of HealthUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 16 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder, Neurogenic
• Urinary Bladder, Neurogenic

Intervention

Drug:
• tamsulosin hydrochloride
Oral
• Placebo
Oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Germany,  India,  Italy,  Korea, Republic of,  Mexico,  Philippines,  Russian Federation,  South Africa,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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.	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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.	No

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