MOVIPREP® Versus PICOLAX® Pilot Study

NCT ID: NCT00312481

Last Updated: 2007-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2006-05-31

Brief 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.

Detailed Description

Gut cleansing will be performed using a split dose of MOVIPREP®, 1-litre solution (1x sachet A and 1x sachet B) in the evening prior to the day of colonoscopy and 1-litre solution (1x sachet A and 1x sachet B) in the morning of the colonoscopy, or PICOLAX®, 150 mL solution (1 sachet) before 8am on day prior to the day of colonoscopy, and 150 mL solution (1 sachet) 6 to 8 hours later.

The primary efficacy measure will be the degree of gut cleansing, as assessed by the physician performing the colonoscopy. A 5-grade scale will be used to assess each of the predefined colon areas, resulting in a final grading (A to D) of the overall quality of the bowel preparation treatment. Grades A and B will be considered as success, and Grades C and D as failure.

The secondary efficacy measures will be:

• is it necessary for the patient to return for a further colonoscopy due to insufficient clearance/cleansing of colon prior to the normal schedule for a repeat procedure?
• taste acceptability
• ease of taking, and ability to complete the bowel preparation treatment
• recommended diet compliance
• would the patient be prepared to repeat the bowel preparation treatment if necessary?
• well-being and effect on usual activities whilst taking the bowel preparation treatment
• overall impression of the bowel preparation treatment prior to colonoscopy
• symptoms experienced since taking their first study bowel preparation treatment and prior to their colonoscopy

Safety and tolerability will be assessed through the collection of adverse events, clinical laboratory tests, physical examination, weight and vital signs (blood pressure and pulse rate) data.

Number of patients:

It is intended to recruit approximately 70 patients in order to achieve at least 60 evaluable patients using a randomisation ratio of 1:1 MOVIPREP®: PICOLAX®.

Conditions

Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

MOVIPREP

Group Type: EXPERIMENTAL

macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate

Intervention Type: DRUG

Split dose, 1-litre solution in the evening prior to colonoscopy and second dose in the morning prior to colonoscopy

2

Picolax

Group Type: ACTIVE_COMPARATOR

NA picosulfate magnesium citrate

Intervention Type: DRUG

150 ml solution before 8am on day prior to colonoscopy and 150ml solution 6 to 8 hours later.

Interventions

macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate

Split dose, 1-litre solution in the evening prior to colonoscopy and second dose in the morning prior to colonoscopy

Intervention Type: DRUG

NA picosulfate magnesium citrate

150 ml solution before 8am on day prior to colonoscopy and 150ml solution 6 to 8 hours later.

Intervention Type: DRUG

Other Intervention Names

MOVIPREP

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norgine

INDUSTRY

Sponsor Role: lead

Responsible Party

Norgine

Principal Investigators

Mike Geraint, MD

Role: STUDY_DIRECTOR

Norgine

Locations

John Radcliffe Hospital, Department of Gastroenterology, Endoscopy Unit, Headley Way, Headington

Oxford, Oxfordshire, United Kingdom

Countries

United Kingdom

References

Hookey LC, Depew WT, Vanner SJ. A prospective randomized trial comparing low-dose oral sodium phosphate plus stimulant laxatives with large volume polyethylene glycol solution for colon cleansing. Am J Gastroenterol. 2004 Nov;99(11):2217-22. doi: 10.1111/j.1572-0241.2004.40482.x.

Reference Type: BACKGROUND

PMID: 15555005 (View on PubMed)

Worthington J, Thyssen M, Chapman G, Chapman R, Geraint M. A randomised controlled trial of a new 2 litre polyethylene glycol solution versus sodium picosulphate + magnesium citrate solution for bowel cleansing prior to colonoscopy. Curr Med Res Opin. 2008 Feb;24(2):481-8. doi: 10.1185/030079908x260844.

Reference Type: DERIVED

PMID: 18179734 (View on PubMed)

Other Identifiers

NRL994-02-2004

Identifier Type: -

Identifier Source: org_study_id