Botox-A Injection to Improve Bladder Function in Early Spinal Cord Injury (#H-20344)

This study has been terminated.
(Funds no longer available)
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Christopher Patrick Smith, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00711087
First received: July 7, 2008
Last updated: September 11, 2015
Last verified: September 2015
Results First Received: September 11, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Neurogenic Bladder Dysfunction Nos
Spinal Cord Injury
Interventions: Drug: BOTOX-A
Other: Saline injection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
ARM 2 Patients in ARM 2 randomized to receive placebo (saline) injections on Days 0 and 90.
ARM 1 Patients in ARM 1 randomized to receive 100 units of BOTOX-A on Day 0 and Day 90

Participant Flow:   Overall Study
    ARM 2     ARM 1  
STARTED     1     0  
COMPLETED     0     0  
NOT COMPLETED     1     0  
Lost to Follow-up                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
ARM 2 Subjects randomized to receive placebo (saline) sham saline injections on Days 0 and 90.
ARM 1 Subjects randomized to receive 100 units of BOTOX-A injections on Days 0 and 90.
Total Total of all reporting groups

Baseline Measures
    ARM 2     ARM 1     Total  
Number of Participants  
[units: participants]
  1     0     1  
Age  
[units: years]
Mean (Full Range)
  36  
  (36 to 36)  
   
   
  36  
  (36 to 36)  
Gender  
[units: participants]
     
Female     0         0  
Male     1         1  
Region of Enrollment  
[units: participants]
     
United States     1         1  



  Outcome Measures

1.  Primary:   A Change in DLPP of 20cm H2O at Day 30 and Day 120 in the BTX-A Injected Group (Group 1) Compared to the Sham Saline Injected Group (Group 2).   [ Time Frame: 2.5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Christopher P. Smith, MD, MBA, MSS
Organization: Baylor College of Medicine
phone: 713-798-7498
e-mail: cps@bcm.edu


Publications:

Responsible Party: Christopher Patrick Smith, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00711087     History of Changes
Other Study ID Numbers: H-20344
Study First Received: July 7, 2008
Results First Received: September 11, 2015
Last Updated: September 11, 2015
Health Authority: United States: Food and Drug Administration