MOVIPREP® Versus PICOLAX® Pilot Study
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 2

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®.
    

Intervention name(s): macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate; NA picosulfate magnesium citrate
Intervention type(s): Drug; Drug
Intervention description(s): Split dose, 1-litre solution in the evening prior to colonoscopy and second dose in the morning prior to colonoscopy; 150 ml solution before 8am on day prior to colonoscopy and 150ml solution 6 to 8 hours later.
Other intervention name(s): MOVIPREP
Intervention MeSH terms: Ascorbic Acid; Magnesium citrate; Picosulfate sodium; Polyethylene glycol 3350
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment