NCT05249335

Brief Summary

This study compares the effectiveness and stability of intestinal tablet (OST), an oral sulfate table (OST), developed in the form of pills, with 2L-PEG/Asc for examinees aged 70 or older who are scheduled for colonoscopy.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
256

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

February 21, 2022

Status Verified

December 1, 2021

Enrollment Period

2 years

First QC Date

January 3, 2022

Last Update Submit

February 9, 2022

Conditions

Colonic DiseaseIntestinal Disease

Keywords

colonoscopyorafangbowel cleaning

Outcome Measures

Primary Outcomes (2)

  • Successful cleaning rate1

    %Patient with Boston Bowel Preparation Scale (BBPS) scored over 2 in all segment

    Two days (from day of first dosing to day of colonoscopy)

  • Successful cleaning rate2

    %Patient with HCS-graded A or B

    Two days (from day of first dosing to day of colonoscopy)

Secondary Outcomes (1)

  • Treatment compliance

    Two days (from day of first dosing to day of colonoscopy)

Other Outcomes (3)

  • Patient satisfaction assessed by questionnaire

    Two days (from day of first dosing to day of colonoscopy)

  • Adenoma/Polyp detection rate, ADR /PDR

    Two days (from day of first dosing to day of colonoscopy)

  • clean cecal intubation time, colonoscopy time

    Two days (from day of first dosing to day of colonoscopy)

Study Arms (2)

OST

EXPERIMENTAL

2 days split dosing regimen

Drug: OST

2L-PEG/Asc

ACTIVE COMPARATOR

2 days split dosing regimen

Drug: 2L-PEG/Asc

Interventions

OSTDRUG

The subject will receive Orafang for colonoscopy

OST
2L-PEG/AscDRUG

The subject will receive 2L-PEG/Asc for colonoscopy

2L-PEG/Asc

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • age over 70
  • Patients who is scheduled a colonoscopy
  • Patients who is informed and give a consent in voluntary

You may not qualify if:

  • History of colectomy
  • Patients over American Society of Anesthesiology class III
  • Patients who has difficulty swallowing
  • In the case of abnormal findings requiring treatment in the basic blood test
  • Patients with uncontrollable chronic diseases
  • Patients suspected of having Paralytic ileus or intestinal obstruction.
  • Patients who complains of alarm sign (severe abdominal pain, weight loss, anemia, gastrointestinal bleeding, etc.)
  • Patients who has a history of drug abuse and addiction
  • Patients who for any reason, are deemed by the Investigator to be inappropriate for this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kang HS, Na SY, Yoon JY, Jung Y, Seo GS, Cha JM. Efficacy, tolerability, and safety of oral sulfate tablet versus 2 L-polyethylene glycol/ascorbate for bowel preparation in older patients: prospective, multicenter, investigator single-blinded, randomized study. J Gastroenterol. 2024 May;59(5):402-410. doi: 10.1007/s00535-024-02089-9. Epub 2024 Mar 16.

    PMID: 38492010DERIVED

MeSH Terms

Conditions

Colonic DiseasesIntestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Cha Jaemyeong, M.D, Ph.D

    Kyung Hee University Hospital at Gangdong

    STUDY CHAIR

  • Gang Hoseok, M.D, Ph.D

    HALLYM UNIV. MEDICAL CENTER

    PRINCIPAL INVESTIGATOR

  • Seo Geomseok, M.D, Ph.D

    Wonkwang University Hospital

    PRINCIPAL INVESTIGATOR

  • Jeong Yunho, M.D, Ph.D

    Soon Chun Hanyang University College of Medicine

    PRINCIPAL INVESTIGATOR

  • Na Suyeong, M.D, Ph.D

    Incheon St.Mary's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cha Jaemyeong, M.D, Ph.D

CONTACT

+82-2-440-6113clicknox@hanmail.net

Yoon Jinyeong

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: multicenter, prospective, investigator single-blinded, randomized study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2022

First Posted

February 21, 2022

Study Start

February 1, 2022

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

February 21, 2022

Record last verified: 2021-12