MOVIPREP® Versus PICOLAX® Pilot Study

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This will be a randomised, single-centre, single-blind, parallel-group, pilot study in patients undergoing colonoscopy.

The primary objective is to evaluate the efficacy of MOVIPREP® versus PICOLAX® for gut cleansing prior to colonoscopy.

The secondary objectives are to evaluate the safety, tolerability and acceptability of MOVIPREP versus PICOLAX for gut cleansing prior to colonoscopy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Norgine
• Treatments: Ascorbic Acid; Magnesium citrate; Picosulfate sodium; Polyethylene glycol 3350

Criteria

Inclusion Criteria:

• written informed consent obtained prior to inclusion

• male or female, aged 18 to 80 years, inclusive, scheduled to undergo a complete colonoscopy

• 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

• if an adequate method of contraception is not being used, the patient will be post hysterectomy, post bilateral oophorectomy, post menopause or have any other condition which precludes pregnancy

• females of childbearing potential must undergo a pregnancy test

Exclusion Criteria:

• ileus

• gastro-intestinal obstruction or perforation

• toxic megacolon, toxic colitis

• congestive heart failure (New York Heart Association [NYHA] III + IV)

• acute life-threatening cardiovascular disease

• acute surgical abdominal conditions

• untreated or uncontrolled arterial hypertension

• known clinically significant reduced renal function with creatinine > 170 µmol/L

• known clinically significant reduced liver function