A Prospective, Randomized, Single-blinded (Investigator), Parallel, Multi-center, Active-control, Non-inferiority, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of MSP01-T for Bowel Cleansing Before Colonoscopy
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 214
- Locations
- 1
- Primary Endpoint
- Proportion of participants with "successful" bowel cleansing based on HCS [by independent central reader]
Study Overview
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 assigned to receive either MSP01-T or a comparator product.
The study will assess how effectively MSP01-T cleans the bowel before the procedure and monitor any potential side effects.
Adults aged 19 years and older who are planning to have a colonoscopy may be eligible to take part.
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 cleansing agent developed to improve patient compliance and cleansing quality while minimizing side effects.
This phase 3, randomized, single-blind, multicenter, active-controlled, non-inferiority clinical trial is designed to evaluate the efficacy and safety of MSP01-T compared to an existing standard bowel preparation. Participants will be randomly assigned to receive MSP01-T or a comparator product before undergoing a colonoscopy.
The primary objective of this study is to assess the quality of bowel preparation as evaluated by endoscopists using a standardized scoring system. Secondary objectives include patient-reported tolerability, safety assessments including adverse events, and overall satisfaction.
Adults aged 19 years and older who are scheduled for a colonoscopy may be eligible to participate in this study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Test Drug Group
2-day split-dose
Intervention: MSP01-T (Drug)
Control Drug Group
2-day split-dose
Intervention: MSP01-R (Drug)
Outcomes
Primary Outcomes
Proportion of participants with "successful" bowel cleansing based on HCS [by independent central reader]
Time Frame: During colonoscopy
Percentage of participants assessed as having "successful" bowel preparation by independent central reader based on Harefield Cleansing Scale (HCS). "Successful" = HCS grade A or B.
Secondary Outcomes
- Proportion of participants with "successful" bowel cleansing based on HCS [by investigator](During colonoscopy)
- Overall bowel cleansing score based on HCS [by independent central reader](During colonoscopy)
- Overall bowel cleansing score based on HCS [by investigator](During colonoscopy)
- Segmental bowel cleansing scores (5 colonic segments) based on HCS [by independent central reader](During colonoscopy)
- Segmental bowel cleansing scores (5 colonic segments) based on HCS [by investigator](During colonoscopy)
- Proportion of participants with residual bubbles based on Bubble Score [by independent central reader](During colonoscopy)
- Proportion of participants with residual bubbles based on Bubble Score [by investigator](During colonoscopy)
- Proportion of participants with detected polyps or adenomas [by investigator](During colonoscopy)
- Proportion of participants with cecal intubation achieved [by investigator](During colonoscopy)
- Colonoscopy insertion time [by investigator](During colonoscopy)
- Colonoscopy withdrawal time [by investigator](During colonoscopy)
- Total colonoscopy procedure time [by investigator](During colonoscopy)
- Study drug administration satisfaction - Difficulty (score)(Immediately after study drug administration)
- Study drug administration satisfaction - Taste (Score)(Immediately after study drug administration)
- Proportion of participants by study drug acceptability(Immediately after study drug administration)
- Proportion of participants by study drug adherence/compliance(Immediately after study drug administration)