Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
This study has been terminated.
(The study was terminated early due to enrollment challenges.)
Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00575016
First received: December 13, 2007
Last updated: September 9, 2011
Last verified: September 2011
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Purpose
The purpose of this study is to explore the effectiveness and safety of several doses of botulinum toxin type A in treating overactive bladder in patients with spinal cord injury.
| Condition | Intervention | Phase |
|---|---|---|
|
Overactive Bladder |
Biological: Normal saline (Placebo); botulinum toxin Type A (200U) Biological: botulinum toxin Type A (50U); botulinum toxin Type A (200U) Biological: botulinum toxin Type A (100U); botulinum toxin Type A (200U) Biological: botulinum toxin Type A (200U) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Allergan:
Primary Outcome Measures:
- Change From Baseline in Number of Weekly Episodes of Urinary Incontinence [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Secondary Outcome Measures:
- Change From Baseline in Maximum Cystometric Capacity (MCC) [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]Change from baseline in MCC at week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds.
- Change From Baseline in Maximum Detrusor Pressure (MDP) [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]Change from baseline in MDP during first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement.
| Enrollment: | 74 |
| Study Start Date: | December 2007 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
botulinum toxin Type A (50U); botulinum toxin Type A (200U)
|
Biological: botulinum toxin Type A (50U); botulinum toxin Type A (200U)
botulinum toxin Type A 50 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
Other Name: BOTOX®
|
|
Experimental: 2
botulinum toxin Type A (100U); botulinum toxin Type A (200U)
|
Biological: botulinum toxin Type A (100U); botulinum toxin Type A (200U)
botulinum toxin Type A 100 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
Other Name: BOTOX®
|
|
Experimental: 3
botulinum toxin Type A (200U)
|
Biological: botulinum toxin Type A (200U)
botulinum toxin Type A 200 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
Other Name: BOTOX®
|
|
4
placebo; botulinum toxin Type A (200U)
|
Biological: Normal saline (Placebo); botulinum toxin Type A (200U)
Placebo injection on Day 1 and botulinum toxin Type A injection 200 U > Week 12; injection into the detrusor
Other Name: BOTOX®
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury
- Inadequate response to anticholinergic medication used to treat overactive bladder
Exclusion Criteria:
- History or evidence of pelvic or urologic abnormality
- Previous or current diagnosis of bladder or prostate cancer
- Urinary tract infection at time of enrollment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00575016
Locations
| Egypt | |
| Cairo, Egypt | |
| Greece | |
| Thessaloniki, Greece | |
| India | |
| Ahmadabad, India | |
| Lebanon | |
| Beirut, Lebanon | |
| Serbia | |
| Belgrade, Serbia | |
| Turkey | |
| Ankara, Turkey | |
Sponsors and Collaborators
Allergan
Investigators
| Study Director: | Medical Director | Allergan |
More Information
No publications provided
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT00575016 History of Changes |
| Other Study ID Numbers: | 191622-518 |
| Study First Received: | December 13, 2007 |
| Results First Received: | September 9, 2011 |
| Last Updated: | September 9, 2011 |
| Health Authority: | India: Drugs Controller General, India, Directorate General of Health Services Greece: National Drug Organization Turkey: Turkish Republic Ministry of Health Egypt: Ministry of Health and Population |
Additional relevant MeSH terms:
|
Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Urological Manifestations Signs and Symptoms Botulinum Toxins, Type A Botulinum Toxins |
Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013