A Study to Evaluate the Safety and Effectiveness of MSP01-T for Bowel Cleansing Before a Colonoscopy

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат MSP01-R
  Total 20 tablets, split-dose administration over 2 days: 14 tablets the day before colonoscopy, 14 tablets on the morning of colonoscopy, oral intake.
• Препарат MSP01-T
  Total 20 tablets, split-dose administration over 2 days: 10 tablets the day before colonoscopy, 10 tablets on the morning of colonoscopy, oral intake.

Первичные конечные точки

• Proportion of participants with "successful" bowel cleansing based on HCS [by independent central reader] [Срок оценки: During colonoscopy]

Вторичные конечные точки (12)

• Proportion of participants with "successful" bowel cleansing based on HCS [by investigator] [Срок оценки: During colonoscopy]
• Overall bowel cleansing score based on HCS [by independent central reader] [Срок оценки: During colonoscopy]
• Overall bowel cleansing score based on HCS [by investigator] [Срок оценки: During colonoscopy]
• Segmental bowel cleansing scores (5 colonic segments) based on HCS [by independent central reader] [Срок оценки: During colonoscopy]
• Segmental bowel cleansing scores (5 colonic segments) based on HCS [by investigator] [Срок оценки: During colonoscopy]
• Proportion of participants with residual bubbles based on Bubble Score [by independent central reader] [Срок оценки: During colonoscopy]
• Proportion of participants with residual bubbles based on Bubble Score [by investigator] [Срок оценки: During colonoscopy]
• Proportion of participants with detected polyps or adenomas [by investigator] [Срок оценки: During colonoscopy]
• Proportion of participants with cecal intubation achieved [by investigator] [Срок оценки: During colonoscopy]
• Colonoscopy insertion time [by investigator] [Срок оценки: During colonoscopy]
• Colonoscopy withdrawal time [by investigator] [Срок оценки: During colonoscopy]
• Total colonoscopy procedure time [by investigator] [Срок оценки: During colonoscopy]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Диагностика

Центры проведения

South Korea · 1 центр

• Kangbuk Samsung Hospital — Seoul

Идентификаторы

NCT: NCT07181148 · MTS-P01-2401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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