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NCT Number: NCT02551198

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

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

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Key information

Conditions

Healthy

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age, between 20 and 75
  • 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

Treatment and study plan

HAPREP®

Drug

Arm1: HAPREP® (2L polyethylene glycol with ascorbic acid; PEG-Asc)

: : PEG-Asc(500mLx2 times q30min)[PM 7-9, the day before colonoscopy] + PEG-Asc(500mLx2 times q30min)[AM 5-7, the day of colonoscopy]

Other names: 2L polyethylene glycol with ascorbic acidl PEG-Asc

SUCLEAR®

Drug

Arm2: SUCLEAR® (oral sulfate solution; OSS): OSS(1b/177mL)[PM 7-9, the day before colonoscopy] + OSS(1b/177mL)[AM 5-7, the day of colonoscopy]

Other names: oral sulfate solution; OSS,

Primary outcomes

  1. Adequacy of bowel preparation

    Time frame: on the day of colonoscopy

Secondary outcomes

  1. 5-point scale symptom questionnaire for drug tolerability

    Time frame: on the day of colonoscopy

    4(distressing) or 5(severely distressing) point would be untolerable

  2. Number of Participants with Adverse Events

    Time frame: on the day of colonoscopy

  3. colonoscopy insertion time

    Time frame: on the day of colonoscopy

  4. adenoma detection rate

    Time frame: whithin 3 weeks from the day of colonoscopy

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Collaborators

  • Daehang Hospital

Registry information

Official study title

Comparative Evaluation the Efficacy of 2L Polyethylene Glycol With Ascorbic Acid (PEG-Asc) and Oral Sulfate Solution (OSS) in Split Method for Bowel Preparation (The Phase III Prospective Randomized Clinical Trial)

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Sep 16, 2015
Registry last updated
Jan 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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