Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-24 @ 10:30 PM
NCT ID:
NCT03017235
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03017235
Study Brief:
Protocol Section:
NCT03017235