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 @ 3:41 PM
Ignite Modification Date:
2025-12-24 @ 3:41 PM
NCT ID:
NCT01689792
Eligibility Criteria:
Inclusion Criteria:
* Patient's written informed consent must be obtained prior to inclusion.
* Male or female outpatients or inpatients aged 40 to 80 years with an indication for complete colonoscopy.
* Willing to undergo a colonoscopy for diagnostic or surveillance purposes
* Patients with a known personal of familial risk of colon neoplasia, willing to undergo a screening colonoscopy
* Willing, able and competent to complete the entire procedure and to comply with study instructions.
* Females of childbearing potential must employ an adequate method of contraception.
Exclusion Criteria:
* History of gastric emptying disorders.
* History of ileus, toxic megacolon, gastrointestinal obstruction and colonic perforation.
* History of phenylketonuria.
* Known glucose-6-phosphate dehydrogenase deficiency.
* Known hypersensitivity to macrogol 3350, sodium sulphate or ascorbic acid/sodium ascorbate.
* History of colonic resection.
* Requirement for permanent medication and associated stable serum concentrations (e.g. neuroleptic drugs).
* Presence of congestive heart failure (NYHA III + IV).
* Acute life-threatening cardiovascular disease.
* Documented history of severe renal insufficiency (creatinine clearance \<30 ml/min).
* Other contraindication described in the summary of product characteristics (SmPC) of either preparation.
* Patient has a condition, clinically significant laboratory results, or is in a situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly.
* Application of any unlicensed medication within the previous 3 months or participation in any other research study in the last 3 months.
* Females who are pregnant, nursing or planning a pregnancy.
* Patients who, in the opinion of the investigator, may not be compliant with the study requirements.
* Previous participation in this clinical study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT01689792
Study Brief:
Protocol Section:
NCT01689792