Status:
COMPLETED
Study to Assess the Tolerability, Safety and Efficacy of an Adapted Gut Cleansing Solution in Routine Colon Cleansing Prior to Colonoscopies
Lead Sponsor:
Norgine
Conditions:
Colon Cancer
Eligibility:
All Genders
45-75 years
Phase:
PHASE2
Brief Summary
It is particularly important that thorough gut cleansing is achieved prior to the colonoscopy for the procedure to be successful. Polyethylene glycol plus electrolyte (PEG+E) solutions are well establ...
Eligibility Criteria
Inclusion
- The subject's written informed consent must be obtained prior to inclusion.
- Male or female ambulatory subjects aged between 40 to 75 years undergoing a complete colonoscopy for colon cancer screening.
- No history of significant gastrointestinal diseases, including gastrointestinal obstruction and perforation or acute symptoms requiring a colonoscopy procedure.
- Willing to undergo a colonoscopy for colon cancer screening.
- 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
- 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
- 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. Females of child bearing potential not using reliable methods of contraception
- Subjects who the investigator feels would not be compliant with the requirements of the trial
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01251237
Start Date
March 1 2010
End Date
July 1 2010
Last Update
December 1 2010
Active Locations (1)
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1
Wolfgang Fischback
Aschaffenburg, Germany, D-63739