This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Colonoscopy
Interventions: Drug: BLI800
Drug: Polyethylene glycol 3350 based bowel preparation

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
  Hide 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
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
  Hide More Information

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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