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

Single-arm clinical trial on the efficacy and safety of MOVICOL as a drug for preparation in children colonoscopy - mPICC

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031230672
Enrollment
36
Registered
2024-03-04
Start date
2025-03-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preparation in children colonoscopy

Interventions

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, juic

Sponsors

Okamoto Kentaro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Bowe cleansing efficacy at the time of endoscopy (percentage of patients with Boston Bowel Preparation Scale (BBPS) >= 6).

Secondary

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

Contacts

Public ContactYoshifumi Ito

Institute of Science Tokyo Hospital

ito.srg2@tmd.ac.jp+81-3-5803-5261

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026