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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:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00575016
First received: December 13, 2007
Last updated: September 9, 2011
Last verified: September 2011
Results First Received: September 9, 2011  
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
Condition: Overactive Bladder
Interventions: 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)

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 74 patients enrolled into the study, 73 patients received study medication and are included in the analyses. One patient was enrolled but did not receive study medication.

Reporting Groups
  Description
Botulinum Toxin Type A (200U) botulinum toxin Type A (200U)
Botulinum Toxin Type A (100U) botulinum toxin Type A (100U)
Botulinum Toxin Type A (50U) botulinum toxin Type A (50U)
Placebo Normal saline (placebo)

Participant Flow for 2 periods

Period 1:   Treatment Cycle 1
    Botulinum Toxin Type A (200U)     Botulinum Toxin Type A (100U)     Botulinum Toxin Type A (50U)     Placebo  
STARTED     17     21     19     17 [1]
COMPLETED     8 [2]   16 [3]   15 [4]   12 [5]
NOT COMPLETED     9     5     4     5  
[1] 1 pt randomized to Placebo never received treatment
[2] 3 pts from 200U group entered Cycle 2
[3] 11 pts from 100U group entered Cycle 2
[4] 8 pts from 50U group entered Cycle 2
[5] 9 pts from Placebo group entered Cycle 2

Period 2:   Treatment Cycle 2
    Botulinum Toxin Type A (200U)     Botulinum Toxin Type A (100U)     Botulinum Toxin Type A (50U)     Placebo  
STARTED     31 [1]   0 [1]   0 [1]   0 [1]
COMPLETED     30     0     0     0  
NOT COMPLETED     1     0     0     0  
[1] All patients received 200U in Treatment Cycle 2.



  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.
No text entered.

Reporting Groups
  Description
Botulinum Toxin Type A (200U) botulinum toxin Type A (200U)
Botulinum Toxin Type A (100U) botulinum toxin Type A (100U)
Botulinum Toxin Type A (50U) botulinum toxin Type A (50U)
Placebo Normal saline (placebo)
Total Total of all reporting groups

Baseline Measures
    Botulinum Toxin Type A (200U)     Botulinum Toxin Type A (100U)     Botulinum Toxin Type A (50U)     Placebo     Total  
Number of Participants  
[units: participants]
  17     21     19     17     74  
Age, Customized  
[units: participants]
         
< 40 years     13     13     16     11     53  
Between 40 and 64 years     4     8     3     6     21  
Between 65 and 74 years     0     0     0     0     0  
>= 75 years     0     0     0     0     0  
Gender  
[units: participants]
         
Female     3     4     2     1     10  
Male     14     17     17     16     64  



  Outcome Measures
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1.  Primary:   Change From Baseline in Number of Weekly Episodes of Urinary Incontinence   [ Time Frame: Baseline, Week 6 ]

2.  Secondary:   Change From Baseline in Maximum Cystometric Capacity (MCC)   [ Time Frame: Baseline, Week 6 ]

3.  Secondary:   Change From Baseline in Maximum Detrusor Pressure (MDP)   [ Time Frame: Baseline, Week 6 ]


  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
Due to recruitment difficulties, study enrollment was stopped early.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: Allergan, Inc.
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com


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