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

• ClinicalTrials.gov Identifier: NCT03992365
• Recruitment Status: Completed
• First Posted: June 20, 2019
• Last Update Posted: March 30, 2020
• Sponsor: Universal Integrated Corp.
• Information provided by (Responsible Party): Universal Integrated Corp.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Bowel Preparation	Drug: Quiklean® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP); Drug: Polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride, aspartame;Bisacodyl	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 472 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomized, evaluator blind, active-controlled, parallel study
• Masking: Single (Outcomes Assessor)
• Masking Description: After bowel preparation, independent evaluator who is blinded to subject's treatment will evaluate the overall colon cleansing based on Aronchick and Ottawa scale.
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: June 10, 2019
• Actual Primary Completion Date: October 15, 2019
• Actual Study Completion Date: January 15, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Quiklean®; Quiklean® (32 tablets)	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.; Other Name: sodium phosphate
Active Comparator: GroKlean-Prep with Dulcolax®; 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; 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 Name: PEG

Outcome Measures

Primary Outcome Measures :

1. Aronchick scale [ Time Frame: up to 24 weeks ]
   The percentage of subjects that achieve excellent or good cleansing (success rate) in the Aronchick Scale.

Secondary Outcome Measures :

1. Ottawa scale [ Time Frame: up to 24 weeks ]
   Proportion of successes (excellent, good, or fair) by individual colon segment (ascending, transverse, descending), which are assessed with the Ottawa scale.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 74 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Subjects with severe chronic constipation, defined as fewer than one bowel movement per week for a period > 1 year.
2. Subjects with known or suspected acute exacerbation of chronic inflammatory bowel disease (IBD).
3. Subjects with significant gastrointestinal disease, such as gastrointestinal obstruction or perforation, active ulcerative colitis, toxic colitis, and toxic megacolon.
4. Subjects with ascites of any etiology.
5. Subjects with renal insufficiency, defined as serum creatinine > 1.5 times the upper limit of normal (ULN).

6. 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.

7. 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.
   • Current use digitalis preparations or any medications known to prolong QT interval.
8. Subjects with history of seizures or at risk of seizure, such as subjects taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), or subjects withdrawing from alcohol or benzodiazepines, subjects with known or suspected hyponatremia.
9. Subject has clinically significant abnormal laboratory values of electrolytes at screening, including phosphorus, sodium, potassium, calcium, chloride, and magnesium.
10. Subjects with history of biopsy-proven acute phosphate nephropathy.
11. Subjects with history of phenylketonuria.
12. Subject has severe dehydration, or severe abdominal pain associated with nausea and vomiting at screening.
13. Subject has problems with swallowing or gastric reflux, or subjects is at risk of aspiration.
14. Subjects is pregnant, lactating women or women of childbearing potential without an effective method of birth control (e.g. oral contraceptive, intrauterine device, surgical sterilization, hysterectomy).
15. Subjects with hypersensitivity to any ingredients in the study medications.
16. Participation in any other investigational study within 30 days prior to receiving study medication.

Contacts and Locations

Locations

Taiwan

China Medical University Hospital

Taichung, Taiwan, 40447

Sponsors and Collaborators

Universal Integrated Corp.

Investigators

• Principal Investigator: Tzu-Liang Chen, Dr; China Medical University Hospital

More Information

• Responsible Party: Universal Integrated Corp.
• ClinicalTrials.gov Identifier: NCT03992365
• Other Study ID Numbers: UIC-STP-2017
• First Posted: June 20, 2019
• Last Update Posted: March 30, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universal Integrated Corp.:

non-inferiority

Additional relevant MeSH terms:

Bisacodyl; Sodium sulfate; Polyethylene glycol 3350; Cathartics; Gastrointestinal Agents; Laxatives