A Phase III Trial to Assess the Efficacy, Acceptability and Safety of Moviprep® Versus a 4L PEG+E Standard Solution

• Status: Completed
• Trial end date: 2002-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study was carried out as a randomised, single-blind, active-controlled, multi-centric, phase III study with two parallel treatment groups. The primary efficacy criterion was the frequency of effective gut cleansing in each of the two treatment groups (grade A or B "overall quality of gut cleansing" as judged by a blinded expert panel on the basis of videotapes recorded during the endoscopic procedure).

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

Details

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

Criteria

Inclusion Criteria:

• written informed consent prior to inclusion;

• male or female in-patients, aged 18 to 85 years, with indication for complete colonoscopy;

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

• females of childbearing potential employing an adequate method of contraception.

Exclusion Criteria:

• ileus;

• intestinal obstruction or perforation;

• toxic megacolon;

• congestive heart failure (NYHA class III and IV);

• acute life-threatening cardiovascular disease;

• untreated or uncontrolled arterial hypertension (SBP max>170mmHg, DBP min>100mmHg);

• severe renal failure;

• severe liver failure;

• known glucose-6-phosphatase dehydrogenase deficiency;