MOVIPREP® Versus PICOLAX® Pilot Study

Norgine

Status and phase

Completed

Phase 2

Conditions

Colonoscopy

Treatments

Drug: NA picosulfate magnesium citrate

Drug: macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00312481

NRL994-02-2004

Details and patient eligibility

About

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.

Full 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®.

Enrollment

65 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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