Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Day Before PicoPrep

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01073943
First received: February 22, 2010
Last updated: October 23, 2012
Last verified: October 2012
Results First Received: August 10, 2012  
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: Bowel Preparation
Interventions: Drug: PicoPrep
Drug: HalfLytely
Drug: 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
PicoPrep "Day Before" method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy
HalfLytely HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.

Participant Flow:   Overall Study
    PicoPrep     HalfLytely  
STARTED     300     303  
Safety Population (Treated)     296     302  
Intent to Treat Population     294 [1]   300 [1]
COMPLETED     287     295  
NOT COMPLETED     13     8  
Withdrawal by Subject                 8                 2  
Protocol Violation                 2                 1  
Adverse Event                 1                 1  
Lost to Follow-up                 0                 2  
Power outage; colonoscopy not done                 1                 0  
Subject forgot                 0                 1  
Unable to return for follow-up                 0                 1  
Could not tolerate prep                 1                 0  
[1] Two treated participants did not have an efficacy assessment performed.



  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
PicoPrep "Day Before" method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy
HalfLytely HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
Total Total of all reporting groups

Baseline Measures
    PicoPrep     HalfLytely     Total  
Number of Participants  
[units: participants]
  296     302     598  
Age  
[units: years]
Mean ± Standard Deviation
  56.8  ± 9.66     56.2  ± 10.11     56.5  ± 9.89  
Gender  
[units: participants]
     
Female     192     189     381  
Male     104     113     217  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     8     15     23  
Not Hispanic or Latino     288     287     575  
Unknown or Not Reported     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaska Native     0     1     1  
Asian     0     1     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     22     32     54  
White     274     268     542  
Other     0     0     0  
Body Mass Index  
[units: kg/m^2]
Mean ± Standard Deviation
  29.185  ± 5.3209     29.541  ± 6.1688     29.365  ± 5.7634  



  Outcome Measures
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1.  Primary:   Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist   [ Time Frame: Day 2 ]
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Measure Type Primary
Measure Title Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist
Measure Description Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Aronchick scale. The Aronchick scale is a 4-step rating scale: inadequate, fair, good, and excellent. Excellent is defined as >90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization. Good is defined as >90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization.
Time Frame Day 2  
Safety Issue No  

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.
Intent-to-treat population of randomized and treated participants with efficacy assessments performed.

Reporting Groups
  Description
PicoPrep "Day Before" method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy
HalfLytely HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.

Measured Values
    PicoPrep     HalfLytely  
Number of Participants Analyzed  
[units: participants]
  294     300  
Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist  
[units: percentage¬†of¬†participants]
  83.0     79.7  


Statistical Analysis 1 for Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Mean Difference (Net) [3] 3.3
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority was demonstrated if the 1-sided 97.5% CI for the treatment difference (PICOPREP minus HalfLytely) was >-9% for the percentage of responders. Superiority was demonstrated if the 1-sided 97.5% CI for treatment difference was >0%.
[3] Other relevant estimation information:
  No text entered.



2.  Secondary:   Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Ascending Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist   [ Time Frame: Day 2 ]

3.  Secondary:   Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug?   [ Time Frame: Day 2 ]

4.  Secondary:   Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed?   [ Time Frame: Day 2 ]

5.  Secondary:   Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation   [ Time Frame: Day 2 ]

6.  Secondary:   Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was   [ Time Frame: Day 2 ]

7.  Secondary:   Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future?   [ Time Frame: Day 2 ]

8.  Secondary:   Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future?   [ Time Frame: Day 2 ]

9.  Secondary:   Participants With Treatment-Emergent Adverse Events (TEAEs)   [ Time Frame: up to one month ]

10.  Other Pre-specified:   Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) For Colon Cleansing According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist   [ Time Frame: Day 2 ]


  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 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: Clinical Development Support
Organization: Ferring Pharmaceuticals
e-mail: DK0-Disclosure@ferring.com


No publications provided


Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01073943     History of Changes
Other Study ID Numbers: 2009-02
Study First Received: February 22, 2010
Results First Received: August 10, 2012
Last Updated: October 23, 2012
Health Authority: United States: Food and Drug Administration