MOVIPREP® Versus NaP Pivotal Phase III Study

• Status: Completed
• Trial end date: 2003-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to compare a new 2 litre bowel cleansing product versus a sodium phosphate solution already on the market. Efficacy of each bowel preparation, safety and acceptability will be assessed.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Norgine
• Treatments: Ascorbic Acid; Pharmaceutical Solutions; Polyethylene glycol 3350

Criteria

Inclusion Criteria:

• male or female, out and inpatients to be at least 18 years old and <75 years old sent to the endoscopic ward for diagnostic or therapeutic colonoscopy

• willing and able to complete the entire procedure and to comply with study instructions

• females of childbearing potential must employ an adequate method of contraception.

Exclusion Criteria:

• age <18 or > 75 years old

• ileus

• suspected intestinal occlusion or perforation

• toxic or congenital megacolon

• history of colonic resection

• patients with Crohn's disease or ulcerative colitis

• congestive heart failure NYHA III or IV

• documented renal insufficiency history with creatinine >170µmol/l

• known hypersensitivity to polyethylene glycols or Na phosphate and/or vitamin C

• concurrent participation in an investigational drug study or participation within 90 days of study entry

• females who are pregnant, or planning a pregnancy. Females of childbearing potential not using reliable methods of contraception

• subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly