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 |
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.
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
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Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
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Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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