Single-arm clinical trial of MOVICOL as a drug for preparation in children colonoscopy

JRCT ID: jRCTs031230672

Registered date:04/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Preparation in children colonoscopy
• Date of first enrollment: 04/03/2024
• Target sample size: 36
• Study type: Interventional

Intervention(s)

MOVICOL should be taken as two packets (120mL) per dose for 2-14 years old children and as three packets (180mL) per dose for over 12 years old, by dissolving one packet in 60 mL of water, tea, juice, or other solution.
The timing and number of doses should be three times in total: in the afternoon and evening on the day before the colonoscopy, and in the morning on the day of the colonoscopy, and each dose should be taken within 2 hours.

Outcome(s)

• Primary Outcome: Bowe cleansing efficacy at the time of endoscopy (percentage of patients with Boston Bowel Preparation Scale (BBPS) >= 6).

Secondary Outcome

Cecal intubation rate.
Acceptability
Tolerability(questionnaire).
Frequency and incidence of adverse events .

Key inclusion & exclusion criteria

• Age minimum: >= 2age old
• Age maximum: <= 15age old
• Gender: Both

Include criteria

1.2 -15 years old at the time of obtaining consent.
2.Written informed consent obtained from patient and/or guardians.

Exclude criteria

1.Patients who have been on fasting for a long period of time and do not need pretreatment.
2.Patients requiring urgent colonoscopy.
3.Patients who are suspected of having bowel obstruction or ileus /intestinal perforation, toxic megacolon, acute abdomen, or stenotic lesions, and who are not eligible for regular preparation.
4.Patients with serious complications.
5.Patients with severe mental disorders or developmental disorders who have difficulty communicating.
6.Patients with a history of severe hypersensitivity to MOVICOL components.
7.Patients who are judged as ineligible for registration by attending doctors.

Related Information

• Primary Sponsor: Okamoto Kentaro