Bowel PreparationPhase 3NCT03992365

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

A Phase 3 study testing Quiklean® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) and Polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride, aspartame;Bisacodyl in people with Bowel Preparation, run by Universal Integrated Corp. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 74 yearsHealthy volunteers can take part
Conditions the study is for: Bowel Preparation
What is being tested?: Quiklean® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) and Polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride, aspartame;Bisacodyl
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 472 participants
Where: 1 siteTaiwan
Study dates: 10 Jun 2019to 15 Jan 2020
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 74 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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:

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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.
Current use digitalis preparations or any medications known to prolong QT interval.
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.
Subject has clinically significant abnormal laboratory values of electrolytes at screening, including phosphorus, sodium, potassium, calcium, chloride, and magnesium.
Subjects with history of biopsy-proven acute phosphate nephropathy.
Subjects with history of phenylketonuria.
Subject has severe dehydration, or severe abdominal pain associated with nausea and vomiting at screening.
Subject has problems with swallowing or gastric reflux, or subjects is at risk of aspiration.
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).
Subjects with hypersensitivity to any ingredients in the study medications.
Participation in any other investigational study within 30 days prior to receiving study medication.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

China Medical University Hospital
Taichung, 40447

Other trials in Taiwan

About this study

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

Read the 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:

Group A: Quiklean® (32 tablets)
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
Being tested: 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
Keywords: non-inferiority

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Quiklean® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP)Drug
Also called sodium phosphate
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.
Polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride, aspartame;BisacodylDrug
Also called PEG
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.

Study groups in NCT03992365
Study group	Role	What they receive
Quiklean®	Experimental	Quiklean® (32 tablets) Receives: 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® Receives: Drug: Polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride, aspartame;Bisacodyl

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 201915 Jan 2020

First posted20 Jun 2019
Study start10 Jun 2019
Primary completion15 Oct 2019
Study completion15 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bowel PreparationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: randomized, evaluator blind, active-controlled, parallel study
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 472 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03992365
Sponsor's protocol ID: UIC-STP-2017
Status last verified: Mar 2020
First submitted: 6 Jun 2019
Last updated: 30 Mar 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
Not yet recruiting
Dose-Escalated Short-Course Proton Therapy for Locally Advanced Rectal Cancer
Locally Advanced Rectal Cancer, Rectal Adenocarcinoma
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
Not yet recruiting
Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Anal Fistula, Rectal Fistula

All Bowel Preparation trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03992365
Acronym / sponsor ID: UIC-STP-2017
Conditions: Bowel Preparation
Keywords: non-inferiority
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 472 participants (actual)
Lead sponsor: Universal Integrated Corp.Industry (pharma, biotech, devices)
Study start: 10 Jun 2019 (actual)
Primary completion: 15 Oct 2019 (actual)
Study completion: 15 Jan 2020 (actual)
First posted: 20 Jun 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Group A: Quiklean® (32 tablets)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: randomized, evaluator blind, active-controlled, parallel study

Arm	Type	Receives
Quiklean®	Experimental	Drug: Quiklean® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP)Quiklean® (32 tablets)
GroKlean-Prep with Dulcolax®	Active comparator	Drug: Polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride, aspartame;Bisacodyl2 sachets of Klean-Prep with 1 tablet of Dulcolax®

Who may qualify

Ages: 20 to 74 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (25 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Quiklean® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP)Also: sodium phosphateThe 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	Quiklean®
Polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride, aspartame;BisacodylAlso: PEGThe 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.	Drug	GroKlean-Prep with Dulcolax®

Primary outcome

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

1 secondary outcome

Ottawa scale
Time frame: up to 24 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
Individual participant dataSharing planned: No

Related trials for Bowel Preparation

RecruitingPhase 1/2
Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)
Ulcerative Colitis (UC), Ulcerative Colitis, Active Moderate
Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
Not yet recruiting
Dose-Escalated Short-Course Proton Therapy for Locally Advanced Rectal Cancer
Locally Advanced Rectal Cancer, Rectal Adenocarcinoma
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
Not yet recruiting
Mechanical Bowel Preparation Prior To Sphincter-Sparing Surgery For Complex Anal Fistulae
Anal Fistula, Rectal Fistula

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tzu-Liang Chen, Dr principal investigator

China Medical University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aronchick scale (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03992365.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.