A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ferring Pharmaceuticals
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy
