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 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT02386904
Eligibility Criteria:
Inclusion Criteria:
1. Male/Female; aged 18-60 years.
2. Out-patients admitted for day care sigmoidoscopy requiring left sided bowel preparation
3. Able to understand the informed consent, answer the questions either independently or with someone helps
Exclusion Criteria:
1. In-patients undergoing sigmoidoscopy or as emergency procedures.
2. Immunosuppressed patients.
3. Patients with electrolyte imbalance or disturbance, Hyperphosphatemia, Hypocalcemia, Hypokalemia, Hypernatremia, Metabolic acidosis.
4. Patients having nausea, vomiting, diarrhea at the time of investigational drug administration.
5. Patients administering the medications known to affect renal perfusion, function, or hydration(Renal failure or acute kidney injury)
6. Patients taking diuretics or other medications within two days prior to the procedure which may alter electrolytes
7. Patients with known hypersensitivity to any ingredient of the study drug/phosphate.
8. Patients requiring colostomy.
9. Conditions causing decreased gastric motility, e.g.,Suspected intestinal obstruction,Paralytic ileus Anorectal stenosis, Imperforate anus, Congenital or acquired megacolon
10. Undiagnosed gastrointestinal pathology, e.g. Symptoms of appendicitis, intestinal perforation or active inflammatory bowel disease, Undiagnosed rectal bleeding, Dehydration and generally in all cases where absorption capacity is increased or elimination capacity is decreased
11. Patients with any neuropathy, renal impairment, liver diseases, diabetes mellitus, Hypertension and any Cardiovascular disease,History of asthma, glaucoma, or raised intraocular pressure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02386904
Study Brief:
Protocol Section:
NCT02386904