F38-27: An Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

This study has been completed.
Sponsor:
Information provided by:
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT00857272
First received: March 5, 2009
Last updated: September 29, 2010
Last verified: September 2010
Results First Received: August 9, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Colonoscopy
Interventions: Drug: PEG electrolyte lavage solution + bisacodyl - reformulation
Drug: PEG electrolyte lavage solution + bisacodyl

  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
No text entered.

Reporting Groups
  Description
HalfLytely With 5mg Bisacodyl Investigational dose
HalfLytely With 10mg Bisacodyl Active Control

Participant Flow:   Overall Study
    HalfLytely With 5mg Bisacodyl     HalfLytely With 10mg Bisacodyl  
STARTED     154 [1]   154 [2]
COMPLETED     145     145  
NOT COMPLETED     9     9  
[1] Includes 6 non-ITT patients that withdrew consent
[2] Includes 7 non-ITT patients that withdrew consent



  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
HalfLytely With 5mg Bisacodyl Investigational dose
HalfLytely With 10mg Bisacodyl Active Control
Total Total of all reporting groups

Baseline Measures
    HalfLytely With 5mg Bisacodyl     HalfLytely With 10mg Bisacodyl     Total  
Number of Participants  
[units: participants]
  154     154     308  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     110     116     226  
>=65 years     44     38     82  
Age  
[units: years]
Mean ± Standard Deviation
  56.8  ± 12.1     55.0  ± 13.0     55.9  ± 12.6  
Gender  
[units: participants]
     
Female     78     90     168  
Male     76     64     140  
Region of Enrollment  
[units: participants]
     
United States     154     154     308  



  Outcome Measures

1.  Primary:   Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale   [ Time Frame: during colonoscopy ]


  Serious Adverse Events


  Other Adverse Events


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Limitations and Caveats
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
Total number of patients experiencing a non-serious adverse event is based on all adverse events, not just those events above the reporting threshold of 3%  


Results Point of Contact:  
Name/Title: John McGowan, Associate Director, Clinical Research
Organization: Braintree Laboratories, Inc.
phone: 781-843-2202
e-mail: jmcgowan@braintreelabs.com


No publications provided


Responsible Party: John McGowan, Associate Director, Clinical Research, Braintree Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00857272     History of Changes
Other Study ID Numbers: F38-27
Study First Received: March 5, 2009
Results First Received: August 9, 2010
Last Updated: September 29, 2010
Health Authority: United States: Food and Drug Administration