A Phase III Trial to Assess the Efficacy, Acceptability and Safety of Moviprep® Versus a 4L PEG+E Standard Solution
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 3

Summary: 
      The study was carried out as a randomised, single-blind, active-controlled, multi-centric,
      phase III study with two parallel treatment groups. The primary efficacy criterion was the
      frequency of effective gut cleansing in each of the two treatment groups (grade A or B
      "overall quality of gut cleansing" as judged by a blinded expert panel on the basis of
      videotapes recorded during the endoscopic procedure).
    

Detailed description: 
      The study was designed as a randomised, active-controlled, single-blind, multi-centre,
      pivotal phase III trial with two parallel treatment groups. 15 German hospitals with
      specialised gastroenterology units were expected to participate in the investigation.

      Up to 360 hospital in-patients routinely scheduled to undergo complete colonoscopy were to be
      enrolled one to two days prior to the endoscopic procedure, and to be randomly allocated to
      one of the two treatment arms in a ratio of 1:1. Bowel preparation was performed using equal
      split doses of either low-volume NRL994 (two doses of 1,000 mL each) or high-volume PEG+E
      (two doses of 2,000 mL each). The first dose was to be taken in the evening before the
      procedure, the second dose on the morning of the day of the colonoscopy. The patients
      allocated to NRL994 were asked to drink at least 1L of additional clear liquid in addition to
      the study drug. During colonoscopy the cleansing of each of the five pre-defined gut segments
      was to be assessed by the physician performing the examination, using a 5-level verbal rating
      scale. Videotapes were to be recorded of all procedures in order to allow central review by a
      blinded and independent expert panel whose ratings were the primary basis for the analysis of
      efficacy. The patients enrolled in the study were asked to fill in a questionnaire concerning
      the acceptability of the preparation. A patient's participation in the study was terminated
      upon completion of the intervention by performing a final examination and filling in the
      study termination page. No interim analysis was to be performed.
    

Intervention name(s): Macrogol3350 NA sulphate NACl KCl ascorbic acid NA ascorbate; Macrogol3350 Na sulphate Na bicarbonate NaCl KCl
Intervention type(s): Drug; Drug
Intervention description(s): 1 pack will consist of 2L NRL 994 - 4 (2 x PEG + E/"P" + 2 x Vitamin C/"C") sachets for the 2L of 2 sachets (1 x "P" plus 1 x "C") will be dissolved in 1L of water. Each litre will be drunk within 1 hour followed by at least 500ml of any additional clear fluid.; 1 pack will consist of 4L PEG + E - contains 4 sachets for the 4L of PEG + E/"P/E". Each sachet will be dissolved in 1L of water. Each litre will be drunk within 1 hour.
Other intervention name(s): MOVIPREP®; KLEAN-PREP®
Intervention MeSH terms: Ascorbic Acid; Polyethylene glycol 3350
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment