A Study to Evaluate the Safety and Effectiveness of MSP01-T for Bowel Cleansing Before a Colonoscopy
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorMather's Pharm. Co., Ltd.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Hemostatic treatment after vascular malformation, ulcer, tumor, or polypectomy
Decompression for non-toxic megacolon or sigmoid volvulus
Foreign body removal
Balloon dilation of strictures
Trial design
Design model
Parallel
Treatments tested in this trial
MSP01-R
DrugTotal 20 tablets, split-dose administration over 2 days: 14 tablets the day before colonoscopy, 14 tablets on the morning of colonoscopy, oral intake.
MSP01-T
DrugTotal 20 tablets, split-dose administration over 2 days: 10 tablets the day before colonoscopy, 10 tablets on the morning of colonoscopy, oral intake.
Treatment groups
214 Participants
are divided into 2 treatment groupsGroup A: Test Drug GroupExperimental treatment 1 intervention
Group B: Control Drug GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants with "successful" bowel cleansing based on HCS [by independent central reader]
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.
Time frame
During colonoscopySecondary outcomes
1
Proportion of participants with "successful" bowel cleansing based on HCS [by investigator]
Percentage of participants assessed as having "successful" bowel preparation by investigator based on Harefield Cleansing Scale (HCS). "Successful" = HCS grade A or B.
Time frame
During colonoscopy2
Overall bowel cleansing score based on HCS [by independent central reader]
Proportion of participants, as assessed by an independent central reader, classified as grade A, B, C, or D based on the Harefield Cleansing Scale (HCS), which evaluates the quality of bowel cleansing. Overall bowel cleansing is considered "successful" if graded A or B, and "unsuccessful" if graded C or D.
Time frame
During colonoscopy3
Overall bowel cleansing score based on HCS [by investigator]
Proportion of participants, as assessed by the investigator, classified as grade A, B, C, or D based on the Harefield Cleansing Scale (HCS), which evaluates the quality of bowel cleansing. Overall bowel cleansing is considered "successful" if graded A or B, and "unsuccessful" if graded C or D.
Time frame
During colonoscopy4
Segmental bowel cleansing scores (5 colonic segments) based on HCS [by independent central reader]
HCS score for each of 5 colonic segments assessed by independent central reader. Each of the five colonic segments is scored on a 5-point scale (0-4) as follows: 0 = Irremovable, heavy, hard stools; 1. = Semi-solid, only partially removable stools; 2. = Brown liquid, removable semi-solid stools; 3. = Clear liquid; 4. = Empty and clean. Scores of 3 or 4 are considered "high quality cleansing."
Time frame
During colonoscopySponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: