Study of the Efficacy and Safety of Quiklean® and Klean-Prep With Dulcolax® for the Bowel Preparation Prior to Colonoscopy
Condition: Bowel Preparation
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective is to demonstrate that investigational drug, Quiklean®, is not inferior to
      standard comparator, Klean-Prep with Dulcolax®, with respect to the overall quality of bowel
      preparation in subjects undergoing colonoscopy.
    

Detailed description: 
      This will be a randomized, evaluator blind, active-controlled, parallel study to compare the
      safety and efficacy of investigational drug (Quiklean®) with standard comparator (Klean-Prep
      with Dulcolax®) in subjects undergoing bowel preparation for colonoscopy. This study will be
      conducted in two arms:

        1. Group A: Quiklean® (32 tablets)

        2. Group B: 2 sachets of Klean-Prep with 1 tablet of Dulcolax® The study will be consist of
           4 clinical visits. Subjects will come to the clinics at Visit 1 (the start of the
           screening), Visit 2 (randomization), and Visit 3 (colonoscopy visit), and Visit 4
           (follow-up visit) according to the pre-defined schedule.

      After the inform consent is obtained from the subject, the designated assessment will be
      performed. If the eligibility criteria has been met, the subjects will be randomly assigned
      with a 1:1 (Group A:B) and scheduled to a colonoscopy. The colonoscopy visit should be
      arranged within 10 days after screening visit and randomization. Subjects are instructed how
      to take study medication, and standard dietary instructions for each group are identical.

      After bowel preparation, the colonoscopy will be performed in the morning by the experienced
      colonoscopist, and the entire process of colonoscopy will be simultaneously recorded by
      video. The quality of bowel cleansing in video will be rated by an independent blinded
      colonoscopist after the completion of colonoscopy.

      The modified Aronchick scale for the primary efficacy endpoint and the Ottawa scale, and
      subject's responses to the acceptability and tolerability for the secondary efficacy endpoint
      will be rated and collected. The safety laboratory examinations from the blood sample,
      solicited events from the start of administration of study medications before colonoscopy,
      and treatment-emergent adverse events will be also recorded.
    

Intervention name(s): Quiklean® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP); Polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride, aspartame;Bisacodyl
Intervention type(s): Drug; Drug
Intervention description(s): The evening before the colonoscopy: Take 4 tablets with 250 ml of clear liquids every 15 minutes for a total of 20 tablets.
On the day of the colonoscopy: Starting 3-5 hours before the procedure, take 4 tablets with 250 ml of clear liquids every 15 minutes for a total of 12 tablets.; The day before the colonoscopy: One 5 mg tablet of Dulcolax® will be administered, do not chew or crush the tablet, in the afternoon before the day of colonoscopy. About 4 hours after administration of Dulcolax®, drink the 1000 ml Klean-Prep solution at a rate of 250 ml every 15 minutes.
On the day of the colonoscopy: Starting 3-5 hours before the procedure, drink the 1000 ml Klean-Prep solution at a rate of 250 ml every 15 minutes.
Other intervention name(s): sodium phosphate; PEG
Intervention MeSH terms: Bisacodyl; Sodium sulfate; Polyethylene glycol 3350
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, evaluator blind, active-controlled, parallel study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: non-inferiority