Comparison of Polyethylene Glycol With Ascorbic Acid and Oral Sulfate Solution for Bowel Preparation

Phase 3

Completed

• Conditions: Healthy
• Interventions: Drug: HAPREP®; Drug: SUCLEAR®

• Registration Number: NCT02551198
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

Colonoscopy is considered by many the preferred mode of screening for colorectal cancer (CRC). The effectiveness of any CRC screening program is critically dependent on an adequate bowel preparation.

For bowel preparation, effective, well-tolerated and safe methods should be applied.

Recently, oral sulfate solution was adopted to Korea. Still, in Korea, there was no data of direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate solution (OSS) in split method for bowel preparation. Therefore, in this study, we planned the comparative evaluation the efficacy of PEG-Asc and OSS in split method for bowel preparation

Detailed Description

For direct comparison of 2L polyethylene glycol with ascorbic acid (PEG-Asc) and oral sulfate solution (OSS) in split method for bowel preparation

Study Timeline

• Study First Submitted: 2015-09-11
• Study First Submitted QC: 2015-09-15
• Study First Posted: 2015-09-16
• Study Start: 2015-11-01
• Primary Completion: 2016-03-01
• Study Completion: 2017-09-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-15
• Last Update Posted: 2019-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

1. Age, between 20 and 75
2. Patients who were visited the outpatient clinic for National Cancer Cancer or Daehang hospital to undergo colonoscopy

Exclusion Criteria

• Gastrointestinal obstruction
• Bowel perforation
• Gastric retention
• Ileus
• Toxic colitis or toxic megacolon
• Known allergies to components of the OSS and PEG-Asc
• History of colorectal resection
• History of abdominopelvic surgery within 6 months
• uncontrolled electrolyte imbalance
• hereditary Phenylketonuria
• Severe dehydration status
• seizure
• coma
• Glucose-6-phosphate dehydrogenase deficiency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HAPREP® (PEG-Asc)	HAPREP®	subjects randomized to 2L polyethylene glycol with ascorbic acid (PEG-Asc) were instructed to use PEG-Asc for bowel preparation : PEG-Asc(500mLx2 times q30min)\[PM 7-9, the day before colonoscopy\] + PEG-Asc(500mLx2 times q30min)\[AM 5-7, the day of colonoscopy\]
SUCLEAR® (OSS)	SUCLEAR®	subjects randomized to oral sulfate solution were instructed to use oral sulfate solution (OSS) for bowel preparation : OSS(1b/177mL)\[PM 7-9, the day before colonoscopy\] + OSS(1b/177mL)\[AM 5-7, the day of colonoscopy\]

Primary Outcome Measures

Name	Time	Method
Adequacy of bowel preparation	on the day of colonoscopy

Secondary Outcome Measures

Name	Time	Method
adenoma detection rate	whithin 3 weeks from the day of colonoscopy
5-point scale symptom questionnaire for drug tolerability	on the day of colonoscopy	4(distressing) or 5(severely distressing) point would be untolerable
Number of Participants with Adverse Events	on the day of colonoscopy
colonoscopy insertion time	on the day of colonoscopy

Trial Locations

Locations (1)

National Cancer Center; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of