The purpose of this study is to compare the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution with PREPOPIK® for colon cleansing in adult subjects undergoing colonoscopy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
917
Supplied as two 160 mL ready-to-drink bottles, per subject, without further reconstitution, before administration.
Supplied as two sachets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Clinical Research Associates
Huntsville, Alabama, United States
Associated Gastroenterology Medical Group
Anaheim, California, United States
GW Research, Inc.
Percentage of Subjects Classified as a Responder Defined by "Excellent" or "Good"
The efficacy of overall colon cleansing in terms of responders was measured by a blinded endoscopist using the Modified Aronchick Scale. Modified Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (\>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (\>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (\>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (\<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed).The participant is considered to be a responder if overall colon cleansing is "excellent" or "good" on this 4-point scale.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Right Segment of the Colon
The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the right segment of the colon was determined. The BBPS scale: 0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Transverse Segment of the Colon
The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the transverse segment of the colon was determined. The BBPS scale: 0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.
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Chula Vista, California, United States
Precision Research Institute
San Diego, California, United States
Connecticut Clinical Research Foundation
Bristol, Connecticut, United States
Florida Clinical Research Group
Clearwater, Florida, United States
Nature Coast Clinical Research
Inverness, Florida, United States
Long Island Gastrointestinal Research Group LLC
Great Neck, New York, United States
Kinston Medical Specialists, PA
Kinston, North Carolina, United States
Wake Research Associates, LLC
Raleigh, North Carolina, United States
...and 4 more locations
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Left Segment of the Colon
The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the left segment of the colon was determined. The BBPS scale: 0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. Subjects in response to questions could provide multiple response if applicable.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations)
Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
Time frame: During colonoscopy procedure (5-9 hours after completed treatment)
Percentage of Treatment-emergent Adverse Events(AEs)
Collected as any AE that begins during the treatment period defined as the period during which a subject receives IMP. All endoscopy findings were reported as AEs while cancers/malignancies detected on endoscopy were reported as SAEs.
Time frame: From baseline (screening) up to day 28 after colonoscopy
Clinically Significant Changes in Vital Signs
Blood pressure and pulse will be measured after at least 5 minutes of rest in supine position and after 3 minutes in standing position
Time frame: From baseline (screening) up to day 28 after colonoscopy
Clinically Significant Changes in Electrocardiogram (ECG)
Measured by standard 12-lead ECG. At each visit when an ECG was done, the investigator reviewed and initialed the tracing, which was then stored with the subject's source documents. The baseline ECG performed at the Screening Visit was reviewed for major abnormalities before dosing.
Time frame: At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy
Clinically Significant Changes in Laboratory Values
Rated by the investigator based on out of range laboratory values
Time frame: At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy