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

NCT00796614 | Completed Phase 2 Results

• 1 other identifier: 527.51
• Study Type: interventional
• Target: 231
• Locations: 13 countries
• Sites: 52

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

Conditions

Bladder, Neurogenic

Keywords

tamsulosin; pediatric; neurogenic bladder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change From Baseline in LPP at Week 14 (End of Treatment)

  Baseline and Week 14

• Percentage Change From Baseline in LPP at Week 14 (End of Treatment)

  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

  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

  Baseline and Week 14

• Change From Baseline in Urine Volume at Week 14

  Baseline and Week 14

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Low dose

EXPERIMENTAL

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

Drug: tamsulosin hydrochloride

Medium dose

EXPERIMENTAL

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

Drug: tamsulosin hydrochloride

High dose

EXPERIMENTAL

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

Drug: tamsulosin hydrochloride

Interventions

tamsulosin hydrochloride DRUG

Oral

Also known as: Flomax, Omnic

High dose; Low dose; Medium dose

Placebo DRUG

Oral

Placebo

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Clinically significant abnormalities as determined by the investigator
• A history of relevant orthostatic hypotension, fainting spells or blackouts

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (52)

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Los Angeles, California, 90027, United States

Location

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Tampa, Florida, 33614, United States

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St Louis, Missouri, 63110, United States

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Buffalo, New York, 14222, United States

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Tarrytown, New York, 10591, United States

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Winston-Salem, North Carolina, 27157, United States

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Akron, Ohio, 44308, United States

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Ghent, 9000, Belgium

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Santo André, 09060-650, Brazil

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São Paulo, 05403-000, Brazil

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Berlin, 10115, Germany

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Deggendorf, 94469, Germany

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Essen, 45122, Germany

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Hamburg, 22763, Germany

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Mainz, 55101, Germany

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Ahmedabad, 380-006, India

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Belagavi, 590-010, India

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Bengaluru, 560-010, India

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Hyderabaad, 500-029, India

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Kochi, 682-026, India

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Lucknow, 226-014, India

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Ludhiana, India

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Manipal, 576-104, India

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Mumbai, 400-008, India

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Nadiād, 387-001, India

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Nagpur, India

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New Delhi, 110-029, India

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Pune, 411-001, India

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Pune, 411-053, India

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Cagliari, 09134, Italy

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Florence, 50139, Italy

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Roma, 00165, Italy

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León, 37660, Mexico

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Puebla City, 72190, Mexico

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Manila, 1000, Philippines

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Pasig, 1604, Philippines

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Quezon City, 1104, Philippines

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Moscow, 119991, Russia

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Saint Petersburg, 194100, Russia

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Bloemfontein, 9300, South Africa

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Cape Town, 7700, South Africa

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Johannesburg, South Africa

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Pretoria, 0028, South Africa

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Roodepoort, South Africa

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Gwangju, 501-757, South Korea

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Incheon, 400-711, South Korea

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Pusan, 602-739, South Korea

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Seoul, South Korea

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Barcelona, 08025, Spain

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Madrid, 28046, Spain

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Málaga, 29011, Spain

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Chernivtsy, 58002, Ukraine

Location

Related Links

• Link to Prescribing Information

MeSH Terms

Conditions

Urinary Bladder, Neurogenic

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Limitations and Caveats

Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 24, 2008
• Study Start: January 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: October 29, 2015
• Results First Posted: September 12, 2012

Record last verified: 2015-09

Locations

BE (1); IN (14); DE (5); US (7); PH (3); ZA (5); RU (2); ES (3); UA (1); KR (4); ME (2); BR (2); IT (3)