A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy
Completed · Phase 3
Conditions studied: Bowel Preparation
In brief
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.
Key facts
- Study ID
- NCT03017235
- Run by
- Ferring Pharmaceuticals
- People needed
- 917
- Starts
- 2017-02-20
- Expected to finish
- 2017-10-12
- Last updated by the study team
- 2018-11-14
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Clinical Research Associates — Huntsville, Alabama, United States
- Associated Gastroenterology Medical Group — Anaheim, California, United States
- GW Research, Inc. — 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
- Hillmont GI — Flourtown, Pennsylvania, United States
- Advanced Research Institute — Ogden, Utah, United States
- Hotel Dieu Hospital — Kingston, Canada
- Canadian Phase Onward, Inc. — Toronto, Canada
Full record on ClinicalTrials.gov
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