Efficacy and Safety of DWJ1609 for Bowel Cleansing Before Colonoscopy; (NCT06062030) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of DWJ1609 for Bowel Cleansing Before Colonoscopy;
South Korea215 participantsStarted 2024-03-08
Plain-language summary
Phase of Development : III
Sponsor : DAEWOONG PHARMACEUTICAL
Study Sites and Principal Investigator : Dong ll Park M.D. Ph.D , Gastroenterology Kangbuk Samsung Hospital and other 6 study sites
Study Period : From the protocol approval date (institutional review board, IRB) 24 Months
Investigational product :
Investigational Products DWJ1609 (sodium sulfate potassium sulfate, Magnesium Sulfate Anhydrous , simethicone, sodium picosulphate)
Control Products DWC202304 (sodium sulfate potassium sulfate, Magnesium Sulfate Anhydrous , simethicone)
Target Diseases : A person who needs treatment before colonoscopy (X-ray, endoscopy)
Number of Subjects : 214 Subjects in total (85 subjects per group, 2 groups in total, considering a 20% dropout rate)
Who can participate
Age range19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Adult men and women 19 years of age or older as of the date of consent in writing
ā. a prospective colonoscopy patient
ā. 19 kg/ć” ā¤ BMI \< 30 kg/ć”
ā. A person who voluntarily agrees to participate in this clinical trial and signs a written agreement Abbreviation: BMI = body mass index
Exclusion criteria
ā. A person who undergoes colonoscopy for the following therapeutic purposes (1) balloon dilatation of the stenosis area (2) non-toxic giant colon or decompression of the S-phase colitis (sigmoid volvulus) (3) Removal of foreign substances (4) Vascular dysplasia, ulcer, tumor and treatment of bleeding after polypectomy (5) Treatment for stenosis or tumor bleeding (palliative treatment)
ā. A person whose past history has been confirmed during a screening visit (1) Severe heart disease (insecurity angina, acute myocardial infarction, acute heart failure, cardiomyopathy, etc.) or acute respiratory failure within 24 weeks prior to screening (2) Epilepsy or seizures within 96 weeks prior to screening (3) Clinically significant intestinal surgical history regardless of duration (e.g., colon premature surgery, colon resection, etc.)
What they're measuring
1
The successful cleaning rate of the Harefield Cleansing Scale (HCS) phase rated as 'success'
Timeframe: from the beginning to the end of colonoscopy (Baseline)
. A person who has been identified or suspected of the following comorbidities during a screening visit (1) active intestinal hemorrhage (2) gastrointestinal obstruction (intestinal obstruction, gastrointestinal obstruction, etc.), gastrointestinal perforation, gastric discharge disorder (gastrointestinal paralysis, gastric congestion, etc.) (3) Inflammatory bowel disease (ulcerative colitis, Crohn's disease, toxic colitis, toxic colitis, etc.) (4) Gastrointestinal ulcers, colorectal mucosal ulcers, ischemic colitis (5) an acute abdominal condition requiring surgery (6) A person who has been identified with the following major cardiovascular diseases
ā. A person who is administering the following drugs during a screening visit or is expected to be administered by the time of completion of a colonoscopy (Day 2; Visit 2) (1) Constipation patients who are regularly administered laxatives or gastrointestinal motility promoters within 12 weeks prior to screening (e.g., two to three times a week or more) (2) Administration of laxatives, enema, simethicone, 5HT4 receptor agonist, iron preparation, opioid excluding clinical trial drugs within 7 days of clinical trial drug administration (Day 1)
ā. A person who is hypersensitive to the ingredients of a clinical trial drug
ā. a pregnant woman or a lactating woman
ā. Fertility women and men who have a pregnancy plan or do not agree to perform appropriate contraception during the clinical trial. Appropriate contraception in this trial is as follows
ā. A person who has participated in another clinical trial/medical device clinical trial within 4 weeks of screening and has received/treated clinical trial medication/medical device