Clinical trial NCT05249335: Comparison for Efficacy and Safety of Bowel Preparation Between Oral Sulfate Table and 2L-polyethylene Glycol/Ascorbate in Elderly
Official title: Comparison for Efficacy and Safety of Bowel Preparation Between Oral Sulfate Table and 2L-polyethylene Glycol/Ascorbate in Elderly: Multicenter, Prospective, Investigator Single-blinded, Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Colonic Disease
Intestinal Disease
Keywords: colonoscopy
orafang
bowel cleaning
Lead sponsor: Pharmbio Korea Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-02-21
Enrollment: 256
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multicenter, prospective, investigator single-blinded, randomized study
Primary purpose: DIAGNOSTIC

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.

Detailed description: This study is comparison for efficacy and safety of bowel preparation between oral sulfate table and 2L-polyethylene glycol/ascorbate in elderly: multicenter, prospective, investigator single-blinded, randomized study. A total of 256 subjects will participate to this study and be assigned to the test group or the control group. The subject will administer the first dose of assigned investigational product in the evening prior to the scheduled colonoscopy. Subject will take the second dose early in the morning of the colonoscopy.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Successful cleaning rate1
timeFrame: Two days (from day of first dosing to day of colonoscopy)
measure: Successful cleaning rate2
timeFrame: Two days (from day of first dosing to day of colonoscopy)
Secondary outcomes:
measure: Treatment compliance
timeFrame: Two days (from day of first dosing to day of colonoscopy)
Other outcomes:
measure: Patient satisfaction assessed by questionnaire
timeFrame: Two days (from day of first dosing to day of colonoscopy)
measure: Adenoma/Polyp detection rate, ADR /PDR
timeFrame: Two days (from day of first dosing to day of colonoscopy)
measure: clean cecal intubation time, colonoscopy time
timeFrame: Two days (from day of first dosing to day of colonoscopy)
Locations:
Study officials:
affiliation: Kyung Hee University Hospital at Gangdong
name: Cha Jaemyeong, M.D, Ph.D
role: STUDY_CHAIR
affiliation: HALLYM UNIV. MEDICAL CENTER
name: Gang Hoseok, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Wonkwang University Hospital
name: Seo Geomseok, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Soon Chun Hanyang University College of Medicine
name: Jeong Yunho, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Incheon St.Mary's Hospital
name: Na Suyeong, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: