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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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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.
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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 
Overall Participants Analyzed 
[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 ]

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 ]
  Hide Outcome Measure 5

Measure Type Secondary
Measure Title Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation
Measure Description Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Fair, Poor, Bad
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. Four participants either did not complete the questionnaire or did not answer this question.

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 
Participants Analyzed 
[Units: Participants]
 292   298 
Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation 
[Units: Percentage of participants]
   
Excellent   45.5   19.1 
Good   43.8   48.7 
Fair   9.2   25.5 
Poor   0.7   3.4 
Bad   0.7   3.4 


Statistical Analysis 1 for Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation
Groups [1] All groups
Method [2] Wilcoxon (Mann-Whitney)
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
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[2] Other relevant method information, such as adjustments or degrees of freedom:
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[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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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