A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:11/16/2018
Start Date:February 20, 2017
End Date:October 12, 2017

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A Randomized, Assessor-Blinded, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution Versus Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Powder for Oral Solution (PREPOPIK®) for Colon Cleansing in Preparation for Colonoscopy

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.


Inclusion Criteria:

- Male or non-pregnant female subjects aged 18 to 80 years, inclusive, being scheduled
to undergo elective colonoscopy

- Females of childbearing potential must agree to use an adequate contraception during
the course of the trial. Accepted forms of contraception are: i.e., implants,
injectables, hormonal intrauterine device, combined hormonal contraceptives, sexual
abstinence, and vasectomized sexual partner. Premenopausal women who are of
childbearing potential must have a negative serum pregnancy test result at screening
and a negative urine pregnancy test result at randomization prior to colonoscopy. In
the case of oral contraceptive use, women should have been taking the same pill
consistently for a minimum of twelve (12) weeks before taking study medication.
Sterilized or postmenopausal women may also participate. Women are considered to be
postmenopausal and are not considered to be of childbearing potential if they have had
twelve (12) months of natural (spontaneous) amenorrhea with an appropriate clinical
profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical
bilateral oophorectomy (with or without hysterectomy) or tubal ligation.

- An average of at least 3 spontaneous bowel movements per week for one month prior to
the colonoscopy

Exclusion Criteria:

- Known or suspected gastrointestinal obstruction, perforation, ileus, or gastric
retention

- Acute intestinal or gastric ulceration

- Severe acute inflammatory bowel disease (IBD), toxic colitis, or toxic megacolon

- Undergoing colonoscopy for foreign body removal or decompression

- Reduced level of consciousness or inability to swallow without aspiration

- Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery, or prior
endoscopic procedures

- Upper gastrointestinal surgery (gastrectomy, gastric banding, gastric by-pass)

- Uncontrolled angina and/or myocardial infarction (MI) within last three months,
congestive heart failure (CHF), uncontrolled hypertension, or ascites

- Severely reduced renal function (<30 mL/min/1.73 m2)

- Pregnant or lactating women

- Any clinically relevant abnormal findings in medical history, physical examination,
vital signs, ECG, clinical chemistry, hematology, coagulation, or urinalysis at
Screening Visit 1

- Rhabdomyolysis

- Chronic nausea and vomiting

- Hypermagnesemia

- Undergoing treatment with Lithium
We found this trial at
13
sites
1211 West La Palma Avenue
Anaheim, California 92801
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701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
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Bristol, Connecticut 06010
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Chula Vista, California 91910
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Clearwater, Florida 33759
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Clearwater, FL
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1811 Bethlehem Pike
Flourtown, Pennsylvania 19031
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Great Neck, New York 11023
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Huntsville, Alabama 35801
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Inverness, Florida 34452
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166 Brock Street
Kingston, K7L 5G2
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Kingston,
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Ogden, Utah 84405
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Ogden, UT
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Raleigh, NC
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San Diego, California 92115
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San Diego, CA
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