4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Study of the Efficacy and Safety of Quiklean® and Klean-Prep With Dulcolax® for the Bowel Preparation Prior to Colonoscopy

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

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
Layout table for study information
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
Layout table for eligibility information
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
Layout table for location information
Taiwan
China Medical University Hospital
Taichung, Taiwan, 40447
Sponsors and Collaborators
Universal Integrated Corp.
Investigators
Layout table for investigator information
Principal Investigator: Tzu-Liang Chen, Dr China Medical University Hospital
Tracking Information
First Submitted Date  ICMJE June 6, 2019
First Posted Date  ICMJE June 20, 2019
Last Update Posted Date March 30, 2020
Actual Study Start Date  ICMJE June 10, 2019
Actual Primary Completion Date October 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
Aronchick scale [ Time Frame: up to 24 weeks ]
The percentage of subjects that achieve excellent or good cleansing (success rate) in the Aronchick Scale.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Efficacy and Safety of Quiklean® and Klean-Prep With Dulcolax® for the Bowel Preparation Prior to Colonoscopy
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Bowel Preparation
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Quiklean®
    Quiklean® (32 tablets)
    Intervention: Drug: Quiklean® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP)
  • Active Comparator: GroKlean-Prep with Dulcolax®
    2 sachets of Klean-Prep with 1 tablet of Dulcolax®
    Intervention: Drug: Polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride, aspartame;Bisacodyl
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2020)
472
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2019)
456
Actual Study Completion Date  ICMJE January 15, 2020
Actual Primary Completion Date October 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03992365
Other Study ID Numbers  ICMJE UIC-STP-2017
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Universal Integrated Corp.
Study Sponsor  ICMJE Universal Integrated Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tzu-Liang Chen, Dr China Medical University Hospital
PRS Account Universal Integrated Corp.
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP