BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

This study has been completed.
Sponsor:
Information provided by:
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT00856843
First received: March 5, 2009
Last updated: October 15, 2010
Last verified: October 2010
Results First Received: September 3, 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: BLI800
Drug: Polyethylene glycol 3350 based bowel preparation

  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
Polyethylene Glycol 3350 Based Bowel Preparation Active control - oral solution, 1 administration
BLI800 Investigational prep - oral solution, 1 administration

Participant Flow:   Overall Study
    Polyethylene Glycol 3350 Based Bowel Preparation     BLI800  
STARTED     68     68  
COMPLETED     66     63  
NOT COMPLETED     2     5  
Withdrawal by Subject                 1                 5  
Lack of Efficacy                 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.
No text entered.

Reporting Groups
  Description
Polyethylene Glycol 3350 Based Bowel Preparation Active control - oral solution, 1 administration
BLI800 Investigational prep - oral solution, 1 administration
Total Total of all reporting groups

Baseline Measures
    Polyethylene Glycol 3350 Based Bowel Preparation     BLI800     Total  
Number of Participants  
[units: participants]
  68     68     136  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     53     50     103  
>=65 years     15     18     33  
Age  
[units: years]
Mean ± Standard Deviation
  56.7  ± 11.0     57.7  ± 10.8     57.2  ± 10.8  
Gender  
[units: participants]
     
Female     31     36     67  
Male     37     32     69  
Region of Enrollment  
[units: participants]
     
United States     68     68     136  



  Outcome Measures
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1.  Primary:   Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale   [ Time Frame: 2 days ]

2.  Secondary:   Assessment of Residual Stool - Cecum   [ Time Frame: 2 days ]

3.  Secondary:   Assessment of Residual Stool - Ascending Colon   [ Time Frame: 2 days ]

4.  Secondary:   Assessment of Residual Stool - Transverse Colon   [ Time Frame: 2 days ]

5.  Secondary:   Assessment of Residual Stool - Descending Colon   [ Time Frame: 2 days ]

6.  Secondary:   Assessment of Residual Stool - Sigmoid Colon/Rectum   [ Time Frame: 2 days ]

7.  Secondary:   Assessment of Residual Fluid - Cecum   [ Time Frame: 2 days ]

8.  Secondary:   Assessment of Residual Fluid - Ascending Colon   [ Time Frame: 2 days ]

9.  Secondary:   Assessment of Residual Fluid - Transverse Colon   [ Time Frame: 2 days ]

10.  Secondary:   Assessment of Residual Fluid - Descending Colon   [ Time Frame: 2 days ]

11.  Secondary:   Assessment of Residual Fluid - Sigmoid Colon/Rectum   [ Time Frame: 2 days ]

12.  Secondary:   Subject Symptom Scores   [ Time Frame: 2 days ]

13.  Secondary:   Mean Change in Serum Chemistry (mg/dL)   [ Time Frame: up to 15 days ]

14.  Secondary:   Mean Change in Serum Chemistry (mEq/L)   [ Time Frame: up to 15 days ]


  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
As prespecified in the study protocol, expected prep related side effects (nausea, vomiting, cramping, bloating and overall discomfort) were only documented as AEs if patients rated them severely distressing on the study questionnaire.


  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.


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


No publications provided by Braintree Laboratories

Publications automatically indexed to this study:

Responsible Party: John McGowan, Associate Director, Clinical Research, Braintree Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00856843     History of Changes
Other Study ID Numbers: BLI800-303
Study First Received: March 5, 2009
Results First Received: September 3, 2010
Last Updated: October 15, 2010
Health Authority: United States: Food and Drug Administration