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
Qualifiers
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
Treatments tested in this trial
- MSP01-R
- MSP01-T
Treatment groups
214 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov