Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening

This was a randomized and multicenter phase III study in ambulatory subjects undergoing an elective colonoscopy for colon cancer screening. Gut cleansing was performed using either the 2 liters of Moviprep gut lavage solution or the 90 ml NaP-containing preparation prior to colonoscopy. Efficacy, acceptability and safety assessments was performed.

Inclusion criteria

• The subject's written informed consent had to be obtained prior to inclusion.
• Male or female ambulatory subjects with an age of 18 to 85 years planned to undergo a complete colonoscopy for colon cancer screening
• Willing, able and competent to complete the entire procedure and to comply with study instructions
• Females of childbearing potential had to employ an adequate method of contraception

Exclusion criteria

• Ileus
• Intestinal obstruction or perforation
• Toxic megacolon
• History of colonic resection
• Requirement for permanent medication and associated stable serum concentrations (e.g. neuroleptic drugs)
• Congestive heart failure (NYHA III + IV)
• Acute life threatening cardiovascular disease
• Untreated or uncontrolled arterial hypertension (max. > 170 mmHg and min > 100 mmHg)
• Known moderate to severe renal insufficiency
• Severe renal failure
• Severe liver failure
• Known glucose 6 phosphatase dehydrogenase deficiency
• Known phenylketonuria
• Known hypersensitivity to polyethylene glycols, NaP and/or Vitamin C
• Concurrent participation in an investigational drug study or participation within 30 days of study entry
• Females who were pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception
• Subject had a condition or was in a situation, which in the investigators opinion might have put the subject at significant risk, might confound the study results, or might interfere significantly.