EUCTR2009-014845-95-DE
Active, not recruiting
Not Applicable
Open study to assess the tolerability, safety and efficacy of an adapted 2 litre gut cleansing solution (NRL0706) in routine colon cleansing prior to colonoscopies for colon tumour screening
orgine Ltd.0 sitesNovember 5, 2009
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Subjects without relevant clinical symptoms for gastrointestinal disorders will undergo a complete selective colonoscopy for colon cancer screening.
- Sponsor
- orgine Ltd.
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. The subject's written informed consent must be obtained prior to inclusion.
- •2\. Male or female ambulatory subjects aged between 40 to 75 years undergoing a
- •complete colonoscopy for colon cancer screening.
- •3\. No history of significant gastrointestinal diseases, including gastrointestinal
- •obstruction and perforation or acute symptoms requiring a colonoscopy procedure.
- •4\. Willing to undergo a colonoscopy for colon cancer screening.
- •5\. Willing, able and competent to complete the entire procedure and to comply
- •with study instructions.
- •6\. Females of childbearing potential must employ an adequate method of contraception.
- •Are the trial subjects under 18? no
Exclusion Criteria
- •1\. History of gastric emptying disorders
- •2\. History of ileus, toxic megacolon, gastrointestinal obstruction and colonic perforation
- •3\. History of Phenylketonuria
- •4\. Known Glucose\-6\-phosphate dehydrogenase deficiency
- •5\. Known hypersensitivity to macrogol 3350, sodium sulphate or ascorbic acid/
- •sodium ascorbate
- •6\. History of colonic resection
- •7\. Requirement for permanent medication and associated stable serum concentrations (e.g. neuroleptic drugs)
- •8\. Presence of congestive heart failure (NYHA III \+ IV)
- •9\. Acute life\-threatening cardiovascular disease
Outcomes
Primary Outcomes
Not specified
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