NCT00312481

MOVIPREP® Versus PICOLAX® Pilot Study

A Randomised, Single-Centre, Parallel-Group, Pilot Study to Assess the Efficacy, Safety and Patient Acceptability of a New 2-Litre Bowel Preparation Agent (MOVIPREP®) Compared With a Standard Bowel Preparation Agent (PICOLAX®)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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
DRUG	NA picosulfate magnesium citrate	150 ml solution before 8am on day prior to colonoscopy and 150ml solution 6 to 8 hours later.

Timeline

• Start date: 2005-07-01
• Completion: 2006-05-01
• First posted: 2006-04-10
• Last updated: 2007-12-17

Locations

1 site across 1 country: United Kingdom