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

NCT03992365 | Completed Phase 3

• 1 other identifier: UIC-STP-2017
• Study Type: interventional
• Target: 472
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bowel Preparation

Keywords

non-inferiority

Outcome Measures

Primary Outcomes (1)

• Aronchick scale

  The percentage of subjects that achieve excellent or good cleansing (success rate) in the Aronchick Scale.

  up to 24 weeks

Secondary Outcomes (1)

• Ottawa scale

  up to 24 weeks

Study Arms (2)

Quiklean®

EXPERIMENTAL

Quiklean® (32 tablets)

Drug: Quiklean® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP)

GroKlean-Prep with Dulcolax®

ACTIVE COMPARATOR

2 sachets of Klean-Prep with 1 tablet of Dulcolax®

Drug: Polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride, aspartame;Bisacodyl

Interventions

Quiklean® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) DRUG

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.

Also known as: sodium phosphate

Quiklean®

Polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride, aspartame;Bisacodyl DRUG

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.

Also known as: PEG

GroKlean-Prep with Dulcolax®

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women 20 and 74 years of age.
• Subject who are scheduled for an elective colonoscopy.
• Ability to complete the entire procedure and to comply with study instructions.
• Will provide completed and signed written informed consents.

You may not qualify if:

• Subjects with severe chronic constipation, defined as fewer than one bowel movement per week for a period \> 1 year.
• Subjects with known or suspected acute exacerbation of chronic inflammatory bowel disease (IBD).
• Subjects with significant gastrointestinal disease, such as gastrointestinal obstruction or perforation, active ulcerative colitis, toxic colitis, and toxic megacolon.
• Subjects with ascites of any etiology.
• Subjects with renal insufficiency, defined as serum creatinine \> 1.5 times the upper limit of normal (ULN).
• Subjects with current or history of abdominal surgeries as follow:
• Acute surgical abdominal conditions.
• Any prior colorectal surgery within previous 3 months at screening, excluding appendectomy, hemorrhoid surgery or prior endoscopic procedures.
• History of ileostomy, right or transverse colostomy, subtotal colectomy with ileosimoidostomy, with ≥ 50% of colon removed, excluding right or left hemicolectomy.
• History of gastric bypass or stapling history.
• Subjects with any serious cardiovascular diseases or related interventions as follows:
• History or current evidence of prolonged QT, unstable angina pectoris, untreated arrhythmia, or uncontrolled hypertension, cardiomyopathy, congestive heart failure (New York Heart Association (NYHA) Functional Classification, grades 3 and 4).
• Myocardial Infarction (MI) within previous 3 months at screening.
• Percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass graft surgery within previous 3 months at screening.
• Subject has undergone cardiovascular stent procedure or carotid artery stenting procedure, and continues to receive an anticoagulant regimen within 1 year prior to screening.

Sponsors & Collaborators

• Universal Integrated Corp.: lead

Study Sites (1)

China Medical University Hospital

Taichung, 40447, Taiwan

Location

MeSH Terms

Interventions

sodium phosphate; polyethylene glycol 3350; Sodium Bicarbonate; Sodium Chloride; Potassium Chloride

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Potassium Compounds

Study Officials

• Tzu-Liang Chen, Dr

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: After bowel preparation, independent evaluator who is blinded to subject's treatment will evaluate the overall colon cleansing based on Aronchick and Ottawa scale.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, evaluator blind, active-controlled, parallel study

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 20, 2019
• Study Start: June 10, 2019
• Primary Completion: October 15, 2019
• Study Completion: January 15, 2020
• Last Updated: March 30, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)