ColonoscopyPhase 3MSP01NCT07181148
A Study to Evaluate the Safety and Effectiveness of MSP01-T for Bowel Cleansing Before a Colonoscopy
A Phase 3 study testing MSP01-R and MSP01-T in people with Colonoscopy and Bowel Preparation, run by Mather's Pharm. Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy, Bowel Preparation
- What is being tested?
- MSP01-R and MSP01-T
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2025to May 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Colonoscopy, Bowel Preparation
- Being tested
- MSP01-R, MSP01-T
- Keywords
- MSP01-T, Colonoscopy, Colon Cleanse, Oral Bowel Cleanser, Oral Tablet, Randomized Trial, Phase 3 Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSP01-RDrug
Also called Orafang Tab
Total 20 tablets, split-dose administration over 2 days: 14 tablets the day before colonoscopy, 14 tablets on the morning of colonoscopy, oral intake.
MSP01-TDrug
Total 20 tablets, split-dose administration over 2 days: 10 tablets the day before colonoscopy, 10 tablets on the morning of colonoscopy, oral intake.
| Study group | Role | What they receive |
|---|---|---|
| Test Drug Group | Experimental | 2-day split-dose Receives: Drug: MSP01-T |
| Control Drug Group | Active comparator | 2-day split-dose Receives: Drug: MSP01-R |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During colonoscopy
Secondary outcomes (16)
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.
Measured: During colonoscopy
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.
Measured: During colonoscopy
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.
Measured: During colonoscopy
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;
- = Semi-solid, only partially removable stools;
- = Brown liquid, removable semi-solid stools;
- = Clear liquid;
- = Empty and clean. Scores of 3 or 4 are considered "high quality cleansing."
Measured: During colonoscopy
Segmental bowel cleansing scores (5 colonic segments) based on HCS [by investigator]
Same as above, but assessed by the site investigator. Each of the five colonic segments is scored on a 5-point scale (0-4) as follows:
0 = Irremovable, heavy, hard stools;
- = Semi-solid, only partially removable stools;
- = Brown liquid, removable semi-solid stools;
- = Clear liquid;
- = Empty and clean. Scores of 3 or 4 are considered "high quality cleansing."
Measured: During colonoscopy
Proportion of participants with residual bubbles based on Bubble Score [by independent central reader]
Proportion of participants with a bubble score of ≥1, as assessed on a 4-point scale (0-3) for overall and segmental evaluation (Grade 0: No or minimal scattered bubbbles, Grade 1: Bubbles covering at least half the luminal diameter, Grade 2: Bubbles covering the circumference of the lumen, Grade 3: Bubbles filling the entire lumen).
Measured: During colonoscopy
Proportion of participants with residual bubbles based on Bubble Score [by investigator]
Same as above, but assessed by the site investigator.
Measured: During colonoscopy
Proportion of participants with detected polyps or adenomas [by investigator]
Participants in whom polyps or adenomas were detected during colonoscopy.
Measured: During colonoscopy
Proportion of participants with cecal intubation achieved [by investigator]
Proportion of participants in whom the colonoscope successfully reached the cecum during colonoscopy
Measured: During colonoscopy
Colonoscopy insertion time [by investigator]
Time from rectal insertion of the colonoscope to confirmation of the cecal base.
Measured: During colonoscopy
Colonoscopy withdrawal time [by investigator]
Time from cecum to anus during colonoscopy withdrawal.
Measured: During colonoscopy
Total colonoscopy procedure time [by investigator]
Total time calculated as the sum of colonoscopy insertion time (from rectal insertion to cecal confirmation) and withdrawal time (from cecal confirmation to removal of the colonoscope from the anus)
Measured: During colonoscopy
Study drug administration satisfaction - Difficulty (score)
Participants rate difficulty of taking study drug on a 5-point Likert scale (1 = very easy, 5 = very difficult); higher scores indicate greater difficulty.
Measured: Immediately after study drug administration
Study drug administration satisfaction - Taste (Score)
Participants rate taste of study drug on a 4-point scale (1 = good, 4 = bad)
Measured: Immediately after study drug administration
Proportion of participants by study drug acceptability
Proportion of participants willing to use the same colon cleansing agent for a future colonoscopy: Yes / No.
Measured: Immediately after study drug administration
Proportion of participants by study drug adherence/compliance
Proportion of participants by total study drug intake: 100%, ≥75% to <100%, <75%.
Measured: Immediately after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mather's Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181148
- Sponsor's protocol ID
- MTS-P01-2401
- Acronym
- MSP01
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07181148
- Acronym / sponsor ID
- MSP01 / MTS-P01-2401
- Conditions
- Colonoscopy, Bowel Preparation
- Keywords
- MSP01-T, Colonoscopy, Colon Cleanse, Oral Bowel Cleanser, Oral Tablet, Randomized Trial, Phase 3 Study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Mather's Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Drug Group | Experimental | Drug: MSP01-T2-day split-dose |
| Control Drug Group | Active comparator | Drug: MSP01-R2-day split-dose |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (37 listed)
- Participants who meet any of the following will NOT be eligible to participate in this clinical trial:
- Colonoscopy for therapeutic purposes, including:
- Medical history at screening, including:
- Concomitant diseases at screening, including:
- Medication use:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSP01-RAlso: Orafang TabTotal 20 tablets, split-dose administration over 2 days: 14 tablets the day before colonoscopy, 14 tablets on the morning of colonoscopy, oral intake. | Drug | Control Drug Group |
| MSP01-TTotal 20 tablets, split-dose administration over 2 days: 10 tablets the day before colonoscopy, 10 tablets on the morning of colonoscopy, oral intake. | Drug | Test Drug Group |
Primary outcome
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.
16 secondary outcomes
Proportion of participants with "successful" bowel cleansing based on HCS [by investigator]
Time frame: During colonoscopy
Overall bowel cleansing score based on HCS [by independent central reader]
Time frame: During colonoscopy
Overall bowel cleansing score based on HCS [by investigator]
Time frame: During colonoscopy
Segmental bowel cleansing scores (5 colonic segments) based on HCS [by independent central reader]
Time frame: During colonoscopy
Segmental bowel cleansing scores (5 colonic segments) based on HCS [by investigator]
Time frame: During colonoscopy
Proportion of participants with residual bubbles based on Bubble Score [by independent central reader]
Time frame: During colonoscopy
Proportion of participants with residual bubbles based on Bubble Score [by investigator]
Time frame: During colonoscopy
Proportion of participants with detected polyps or adenomas [by investigator]
Time frame: During colonoscopy
Proportion of participants with cecal intubation achieved [by investigator]
Time frame: During colonoscopy
Colonoscopy insertion time [by investigator]
Time frame: During colonoscopy
Colonoscopy withdrawal time [by investigator]
Time frame: During colonoscopy
Total colonoscopy procedure time [by investigator]
Time frame: During colonoscopy
Study drug administration satisfaction - Difficulty (score)
Time frame: Immediately after study drug administration
Study drug administration satisfaction - Taste (Score)
Time frame: Immediately after study drug administration
Proportion of participants by study drug acceptability
Time frame: Immediately after study drug administration
Proportion of participants by study drug adherence/compliance
Time frame: Immediately after study drug administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MSP01-R and MSP01-T in people with Colonoscopy and Bowel Preparation, run by Mather's Pharm. Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with "successful" bowel cleansing based on HCS [by independent central reader] (time frame: During colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.