Clinical Trials List
Protocol NumberUIC-SPT-2017
2018-11-01 - 2019-10-31
Phase III
Terminated1
Study ended1
ICD-10Z13.811
Encounter for screening for lower gastrointestinal disorder
ICD-9V82.89
Special screening for other specified conditions
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
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Trial Applicant
STATPLUS, INC.
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Sponsor
-
Trial scale
Taiwan Single Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 江驊哲 Division of Colorectal Surgery
- 謝明皓 Division of Colorectal Surgery
- Tao-Wei Ke Division of Colorectal Surgery
- 黃郁純 Division of Colorectal Surgery
- 謝右文 藥劑部
- 陳宏彰 Division of Colorectal Surgery
- 陳奕彰 Division of Colorectal Surgery
- Hwei-Ming Wang Division of Colorectal Surgery
- 張伸吉 Division of Colorectal Surgery
- 蔡元耀 Division of Colorectal Surgery
The Actual Total Number of Participants Enrolled
442 Study ended
Condition/Disease
bowel preparation in subjects undergoing colonoscopy
Objectives
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.
Test Drug
Quiklean
Active Ingredient
sodium phosphate
Dosage Form
tablet
Dosage
1.5 g sodium phosphate
Endpoints
Primary endpoint:
*The percentage of subjects that achieve excellent or good cleansing (success rate) in the Aronchick Scale.
Secondary endpoints:
Efficacy Endpoints
*Proportion of successes (excellent, good, and fair) by individual colon segment (ascending,
transverse, descending), which are assessed with the Ottawa scale.
*Mean bowel preparation score assessed with Ottawa Scale by adding points for the
cleansing of three parts of colon and points for amount of fluid in the bowel.
*Percentage of subject’s responses to the acceptability and tolerability.
Safety Endpoints
*Percentage of subjects occurred solicited events from the start of administration of study medications before colonoscopy.
*Percentage of subjects with treatment-emergent adverse events during the study period.
*The percentage of subjects that achieve excellent or good cleansing (success rate) in the Aronchick Scale.
Secondary endpoints:
Efficacy Endpoints
*Proportion of successes (excellent, good, and fair) by individual colon segment (ascending,
transverse, descending), which are assessed with the Ottawa scale.
*Mean bowel preparation score assessed with Ottawa Scale by adding points for the
cleansing of three parts of colon and points for amount of fluid in the bowel.
*Percentage of subject’s responses to the acceptability and tolerability.
Safety Endpoints
*Percentage of subjects occurred solicited events from the start of administration of study medications before colonoscopy.
*Percentage of subjects with treatment-emergent adverse events during the study period.
Inclution 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.
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 1. 1. 1. 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:
(1) Acute surgical abdominal conditions(e.g. acute obstruction or perforation, etc.).
(2) Any prior colorectal surgery within previous 3 months at screening, excluding
appendectomy, hemorrhoid surgery or prior endoscopic procedures.
(3) History of ileostomy, right or transverse colostomy, subtotal colectomy with
ileosimoidostomy, with ≥ 50% of colon removed, excluding right or left
hemicolectomy.
(4) History of gastric bypass or stapling history.
7. Subjects with any serious cardiovascular diseases or related interventions as follows,
(1) 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).
(2) Myocardial Infarction (MI) within previous 3 months at screening.
(3) Percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass
graft surgery within previous 3 months at screening.
(4) Subject has undergone cardiovascular stent procedure or carotid artery stenting
procedure, and continues to receive an anticoagulant regimen within 1 year prior to
screening.
(5) 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.
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:
(1) Acute surgical abdominal conditions(e.g. acute obstruction or perforation, etc.).
(2) Any prior colorectal surgery within previous 3 months at screening, excluding
appendectomy, hemorrhoid surgery or prior endoscopic procedures.
(3) History of ileostomy, right or transverse colostomy, subtotal colectomy with
ileosimoidostomy, with ≥ 50% of colon removed, excluding right or left
hemicolectomy.
(4) History of gastric bypass or stapling history.
7. Subjects with any serious cardiovascular diseases or related interventions as follows,
(1) 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).
(2) Myocardial Infarction (MI) within previous 3 months at screening.
(3) Percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass
graft surgery within previous 3 months at screening.
(4) Subject has undergone cardiovascular stent procedure or carotid artery stenting
procedure, and continues to receive an anticoagulant regimen within 1 year prior to
screening.
(5) 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.
The Estimated Number of Participants
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Taiwan
456 participants
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Global
456 participants
