Status:
NOT_YET_RECRUITING
A Study to Evaluate the Safety and Effectiveness of MSP01-T for Bowel Cleansing Before a Colonoscopy
Lead Sponsor:
Mather's Pharm. Co., Ltd.
Conditions:
Colonoscopy
Bowel Preparation
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
This study is being conducted to evaluate the safety and effectiveness of MSP01-T, a new bowel cleansing agent, in adults who are scheduled to undergo a colonoscopy. Participants will be randomly ass...
Detailed Description
Colonoscopy is a widely used diagnostic and screening procedure for colorectal diseases. Adequate bowel cleansing is essential for the accuracy and safety of the procedure. MSP01-T is a new bowel clea...
Eligibility Criteria
Inclusion
- Male or female participants aged 19 years or older at the time of providing written informed consent.
- Individuals scheduled to undergo a screening colonoscopy.
- 19 kg/㎡ ≤ BMI \< 30 kg/㎡
- Participants who have voluntarily agreed to participate in the clinical trial and have provided written informed consent.
Exclusion
- Participants who meet any of the following will NOT be eligible to participate in this clinical trial:
- Colonoscopy for therapeutic purposes, including:
- Hemostatic treatment after vascular malformation, ulcer, tumor, or polypectomy
- Decompression for non-toxic megacolon or sigmoid volvulus
- Foreign body removal
- Balloon dilation of strictures
- Palliative treatment for bleeding due to strictures or tumors
- Medical history at screening, including:
- Epilepsy or seizure within 2 years
- Severe cardiac disease within 24 weeks (e.g., unstable angina, acute myocardial infarction)
- Clinically significant gastrointestinal or abdominal surgery within 24 weeks (except appendectomy, hemorrhoidectomy)
- Active infection or fever ≥ 38°C within 1 week (except mild upper respiratory infection or localized skin infection)
- Hypersensitivity to investigational product components
- Concomitant diseases at screening, including:
- Active gastrointestinal bleeding
- Coagulation disorders
- Gastrointestinal obstruction, perforation, or gastric emptying disorders
- Inflammatory bowel disease (e.g., Crohn's disease, toxic megacolon, toxic colitis)
- Acute abdomen requiring surgery
- Major cardiovascular disease (e.g., congestive heart failure \[NYHA class III-IV\], clinically significant arrhythmia, QTcF \> 450 msec \[male\] or \> 470 msec \[female\])
- Uncontrolled hypertension (systolic blood pressure \> 170 mmHg or diastolic blood pressure \> 100 mmHg)
- Insulin therapy requirement
- Clinically significant electrolyte imbalance
- Risk of dehydration (e.g., rhabdomyolysis, ascites)
- Severe renal impairment (eGFR \< 30 mL/min/1.73 m²)
- ALT or AST \> 3 × ULN
- Severe nausea or vomiting interfering with trial participation
- Active hepatitis B (HBsAg positive) or hepatitis C (HCV Ab positive)
- HIV positive
- Neurological or psychiatric disorders (e.g., depression, bipolar disorder, epilepsy, substance abuse) or use of related medications
- Medication use:
- Severe constipation (bowel movement \< 3/week) or regular use of laxatives/prokinetics within 12 weeks
- Use of laxatives, enemas, simethicone, 5-HT4 agonists, iron, or opioids within 7 days before Day 1
- Pregnant or breastfeeding women
- Women of childbearing potential and men unwilling to use effective contraception during the study
- Participation in another clinical trial and receipt of investigational drug or device within 4 weeks
- Any condition judged inappropriate by the investigator
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT07181148
Start Date
October 1 2025
End Date
May 1 2026
Last Update
September 25 2025
Active Locations (1)
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1
Kangbuk Samsung Hospital
Seoul, South Korea