A Randomized Prospective Trial Comparing Polyethylene Glycol and Sodium Picosulphate With Magnesium Citrate

NCT01778192 | Completed Phase 3 DMC

• 1 other identifier: Korea University
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Adequate bowel cleansing is important for a completeness of colonoscopy and detection of colon polyps. Inadequate bowel preparation leads to longer duration of colonoscopy and obscured mucosal visualization resulting in missed lesions. Bowel cleansing agents are simply classified into the large volume, iso-osmotic polyethylene glycol (PEG) based solutions or the small volume osmotically active agents, such as sodium picosulphate with magnesium citrate (SPMC). There are rare reports that compare directly conventional polyethylene glycol (PEG) solution and sodium picosulphate with magnesium citrate (SPMC) for bowel preparation in korea. The aim of this study is to compare the efficacy, safety, and tolerability of different regimens of SPMC and PEG solution.

Conditions

Colorectal Cancer; Colon Adenoma

Keywords

Bowel preparation; Polyethylene glycol; Sodium picosulphate

Outcome Measures

Primary Outcomes (1)

• the quality of the bowel preparation using the Ottawa bowel preparation scale (OBPS)

  Immediately following the colonoscopy, the endoscopist who were unaware of the preparation regimen scored the quality of the bowel preparation using the Ottawa bowel preparation scale (OBPS).

  20 minutes

Secondary Outcomes (3)

• Completeness of the bowel preparation

  30 minutes before the colonoscopy

• the patient's tolerability

  30 minutes before the colonoscopy

• the side effects of the sodium picosulphate and magnesium citrate

  1 hour before the colonoscopy

Study Arms (4)

Same day PEG

ACTIVE COMPARATOR

group 1 (same day PEG, N=50) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy

Drug: Polyethylene glycol

split PEG

ACTIVE COMPARATOR

group 2 (split PEG, N=50) received 2 L of PEG at 6:00 p.m the evening before colonoscopy and 2 L of PEG at 4-6 hours before procedure

Drug: Polyethylene glycol

SPMC 2

ACTIVE COMPARATOR

group 3 (SPMC 2, N=50) received one sachet of SPMC at 6 p.m the evening before colonoscopy and another sachet of SPMC at 4-6 hours before procedure

Drug: Sodium picosulphate with magnesium citrate

SPMC 3

ACTIVE COMPARATOR

group 4 (SPMC 3, N=50) received one sachet of SPMC at 6 p.m and the other sachet at 9 p.m the evening before colonoscopy and another sachet at 4-6 hours before procedure.

Drug: Sodium picosulphate with magnesium citrate

Interventions

Polyethylene glycol DRUG

-group 1 (same day PEG) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy

Also known as: Colyte(Taejoon Pharmaceuticals, Seoul, Korea)

Same day PEG

Sodium picosulphate with magnesium citrate DRUG

-group 3 (SPMC 2) received one sachet of SPMC at 6 p.m the evening before colonoscopy and another sachet of SPMC at 4-6 hours before procedure

Also known as: Picolight(Pharmbio korea, Seoul, Korea)

SPMC 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients, aged between18 and 75 years undergoing elective outpatient colonoscopy were eligible for the study

You may not qualify if:

• gastrointestinal obstruction or perforation, toxic megacolon, severe uncontrolled inflammatory bowel disease, previous colorectal resection, congestive heart failure, recent acute myocardial infarction or unstable angina, uncontrolled arterial hypertension, renal insufficiency with glomerular filtration rate \< 60 ml/minute/1.73 m2, liver cirrhosis or ascites, pregnancy, lactation, and history of hypersensitivity to any bowel cleansing agents.

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine

Seoul, ASI|KR|KS013|SEOUL, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Polyethylene Glycols; picosulfate sodium; magnesium citrate

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Yoon Tae Jeen

  Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea

  STUDY DIRECTOR

• Eun Sun Kim

  Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea

  PRINCIPAL INVESTIGATOR

• Woo Jin Lee

  Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: fellow

Study Record Dates

• First Submitted: January 25, 2013
• First Posted: January 29, 2013
• Study Start: July 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 31, 2013

Record last verified: 2013-01

Locations

KR (1)