NCT03992365

Study of the Efficacy and Safety of Quiklean® and Klean-Prep With Dulcolax® for the Bowel Preparation Prior to Colonoscopy

A Prospective, Randomized, Evaluator Blind, Active-Controlled, Parallel Study of the Efficacy and Safety of Quiklean® and Klean-Prep With Dulcolax® for the Bowel Preparation Prior to Colonoscopy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 472 (actual)
• Sponsor: Universal Integrated Corp. · Industry
• Sex: All
• Age: 20 Years – 74 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bowel Preparation

Interventions

Type	Name	Description
DRUG	Quiklean® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP)	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.
DRUG	Polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride, aspartame;Bisacodyl	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.

Timeline

• Start date: 2019-06-10
• Primary completion: 2019-10-15
• Completion: 2020-01-15
• First posted: 2019-06-20
• Last updated: 2020-03-30

Locations

1 site across 1 country: Taiwan