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| Sponsored by: |
Allergan |
| Information provided by: | Allergan |
| ClinicalTrials.gov Identifier: | NCT00575016 |
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: placebo/botulinum toxin Type A Biological: botulinum toxin Type A Biological: Botulinum toxin Type A |
Phase II |
| MedlinePlus related topics: | Botox |
| ChemIDplus related topics: | Sodium chloride Clostridium botulinum toxin |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Estimated Enrollment: | 160 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1: Experimental |
Biological: botulinum toxin Type A
botulinum toxin Type A 50 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
|
| 2: Experimental |
Biological: botulinum toxin Type A
botulinum toxin Type A 100 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
|
| 3: Experimental |
Biological: Botulinum toxin Type A
botulinum toxin Type A 200 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
|
|
4
Placebo followed by experimental
|
Biological: placebo/botulinum toxin Type A
Placebo injection on Day 1 and botulinum toxin Type A injection 200 U > Week 12; injection into the detrusor
|
Eligibility
| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Allergan Inc | clinicaltrials@allergan.com |
| Serbia and Montenegro | |||||
| Recruiting | |||||
| Belgrade, Serbia and Montenegro | |||||
| Allergan |
| Study Director: | Medical Director | Allergan |
More Information
Related Info 
  |
| Responsible Party: | Allergan, Inc. ( Therapeutic Area Head ) |
| Study ID Numbers: | 191622-518 |
| First Received: | December 13, 2007 |
| Last Updated: | May 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00575016 |
| Health Authority: | Denmark: Danish Medicines Agency |
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