Bladder, NeurogenicPhase 2/3NCT00796614

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

A Phase 2/3 study testing tamsulosin hydrochloride in people with Bladder, Neurogenic, run by Boehringer Ingelheim at 52 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 Read more about this study

Who is it for?: Ages 2 to 16 years
Conditions the study is for: Bladder, Neurogenic
What is being tested?: tamsulosin hydrochloride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 231 participants
Where: 52 sitesin 13 countries
Study dates: Jan 2008to Feb 2009
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

52 sites in 13 countries.

Country

City, postcode or hospital

52 sites in 13 countries

India14 sites

Study site
Ahmedabad, 380-006
Study site
Belagavi, 590-010
Study site
Bengaluru, 560-010
Study site
Hyderabaad, 500-029
Study site
Kochi, 682-026
Study site
Lucknow, 226-014
Study site
Ludhiana
Study site
Manipal, 576-104
Study site
Mumbai, 400-008
Study site
Nadiād, 387-001
Study site
Nagpur
Study site
New Delhi, 110-029
Study site
Pune, 411-001
Study site
Pune, 411-053

Other trials in India

United States7 sites

Study site
Akron, Ohio, 44308
Study site
Buffalo, New York, 14222
Study site
Los Angeles, California, 90027
Study site
St Louis, Missouri, 63110
Study site
Tampa, Florida, 33614
Study site
Tarrytown, New York, 10591
Study site
Winston-Salem, North Carolina, 27157

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Germany5 sites

Study site
Berlin, 10115
Study site
Deggendorf, 94469
Study site
Essen, 45122
Study site
Hamburg, 22763
Study site
Mainz, 55101

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South Africa5 sites

Study site
Bloemfontein, 9300
Study site
Cape Town, 7700
Study site
Johannesburg
Study site
Pretoria, 0028
Study site
Roodepoort

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South Korea4 sites

Study site
Gwangju, 501-757
Study site
Incheon, 400-711
Study site
Pusan, 602-739
Study site
Seoul

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Italy3 sites

Study site
Cagliari, 09134
Study site
Florence, 50139
Study site
Roma, 00165

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Philippines3 sites

Study site
Manila, 1000
Study site
Pasig, 1604
Study site
Quezon City, 1104

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Spain3 sites

Study site
Barcelona, 08025
Study site
Madrid, 28046
Study site
Málaga, 29011

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Brazil2 sites

Study site
Santo André, 09060-650
Study site
São Paulo, 05403-000

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Mexico2 sites

Study site
León, 37660
Study site
Puebla City, 72190

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Russia2 sites

Study site
Moscow, 119991
Study site
Saint Petersburg, 194100

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Belgium1 site

Study site
Ghent, 9000

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Ukraine1 site

Study site
Chernivtsy, 58002

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About this study

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

Conditions: Bladder, Neurogenic
Being tested: tamsulosin hydrochloride, Placebo
Keywords: tamsulosin, pediatric, neurogenic bladder
Medical subject headings: Urinary Bladder, Neurogenic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tamsulosin hydrochlorideDrug
Also called Flomax, Omnic
Oral
PlaceboDrug
Oral

Study groups in NCT00796614
Study group	Role	What they receive
Placebo	Placebo comparator	Participants received matching placebo to tamsulosin hydrochloride via opened capsules every day for 14 weeks Receives: Drug: Placebo
Low dose	Experimental	Participants received 0.001 - 0.002 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks Receives: Drug: tamsulosin hydrochloride
Medium dose	Experimental	Participants received 0.002 - 0.004 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks Receives: Drug: tamsulosin hydrochloride
High dose	Experimental	Participants received 0.004 - 0.008 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks Receives: Drug: tamsulosin hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Week 14

Secondary outcomes (8)

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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 14.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Feb 2009

First posted24 Nov 2008 (estimated)
Study startJan 2008
Primary completionFeb 2009
Study completionFeb 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Bladder, NeurogenicStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 231 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00796614
Sponsor's protocol ID: 527.51
Status last verified: Sep 2015
First submitted: 20 Nov 2008
Last updated: 29 Oct 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Recruiting
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY IN CHILDREN WITH SPINAL DYSRAPHISM.
Neurogenic Bladder Due to Spinal Dysraphism
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder
Recruiting
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis
Active, not recruitingObservational study
Pediatric Locomotor Training Bladder Study
Spinal Cord Injuries, Neurogenic Bladder

All Bladder, Neurogenic trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00796614
Acronym / sponsor ID: 527.51
Conditions: Bladder, Neurogenic
Keywords: tamsulosin, pediatric, neurogenic bladder
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 231 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 24 Nov 2008 (estimated)
Results: Posted 12 Sep 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipants received matching placebo to tamsulosin hydrochloride via opened capsules every day for 14 weeks
Low dose	Experimental	Drug: tamsulosin hydrochlorideParticipants received 0.001 - 0.002 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks
Medium dose	Experimental	Drug: tamsulosin hydrochlorideParticipants received 0.002 - 0.004 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks
High dose	Experimental	Drug: tamsulosin hydrochlorideParticipants received 0.004 - 0.008 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks

Who may qualify

Ages: 2 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
tamsulosin hydrochlorideAlso: Flomax, OmnicOral	Drug	High dose, Low dose, Medium dose
PlaceboOral	Drug	Placebo

Primary outcome

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.
Time frame: Week 14
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.

8 secondary outcomes

Change From Baseline in LPP at Week 14 (End of Treatment)
Time frame: Baseline and Week 14
Percentage Change From Baseline in LPP at Week 14 (End of Treatment)
Time frame: 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
Time frame: 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
Time frame: Baseline and Week 14
Change From Baseline in Urine Volume at Week 14
Time frame: Baseline and Week 14
Change From Baseline in Number of Times Patient Was Wet at Catheterisation
Time frame: 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.
Time frame: From first drug administration until 28 days after last study drug administration, upto 160 days
Post Void Residual Volume at Week 14
Time frame: Baseline and Week 14.

Results and safety

Results posted to the registry on 12 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	41	36
Tamsulosin - Low Dose Level	40	36
Tamsulosin - Medium Dose Level	39	36
Tamsulosin - High Dose Level	41	40

Primary outcome: 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.

Time frame: Week 14. Number. Unit: Percentage of participants

Measure	Placebo n = 34	Tamsulosin - Low Dose Level n = 35	Tamsulosin - Medium Dose Level n = 33	Tamsulosin - High Dose Level n = 33
Value	35.3	45.7	27.3	42.4

Placebo vs Tamsulosin - Low Dose Level: Odds Ratio (OR): 1.38 (95% CI 0.50 to 3.80), p = 0.5388, Regression, Logistic
Placebo vs Tamsulosin - Medium Dose Level: Odds Ratio (OR): 0.59 (95% CI 0.20 to 1.76), p = 0.3430, Regression, Logistic
Placebo vs Tamsulosin - High Dose Level: Odds Ratio (OR): 1.41 (95% CI 0.50 to 3.97), p = 0.5209, Regression, Logistic

Population analysed: Full analysis set-LPP (FAS-LPP): Includes all patients in the treated set who received at least one dose of randomised. FAS-LPP contains same patients as TS.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 28 days after last study drug administration, upto 160 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 41 (2.4%)	13 of 41 (31.7%)	Not reported
Tamsulosin - Low Dose Level	1 of 120 (0.8%)	19 of 120 (15.8%)	Not reported
Tamsulosin - Medium Dose Level	0 of 80 (0%)	14 of 80 (17.5%)	Not reported
Tamsulosin - High Dose Level	0 of 40 (0%)	8 of 40 (20%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Link to Prescribing InformationLink provided by the sponsor.

Related trials for Bladder, Neurogenic

Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Recruiting
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY IN CHILDREN WITH SPINAL DYSRAPHISM.
Neurogenic Bladder Due to Spinal Dysraphism
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
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Recruiting
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis
Active, not recruitingObservational study
Pediatric Locomotor Training Bladder Study
Spinal Cord Injuries, Neurogenic Bladder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

52 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing tamsulosin hydrochloride in people with Bladder, Neurogenic, run by Boehringer Ingelheim at 52 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in India, United States, Germany, South Africa, South Korea and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Week 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00796614.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2015.