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

NCT01778192 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2013-01-31

No results posted yet for this study

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

Interventions

DRUG

Polyethylene glycol

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

DRUG

Polyethylene glycol

-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

Sodium picosulphate with magnesium citrate

-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

DRUG

Sodium picosulphate with magnesium citrate

-group 4 (SPMC 3) 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.

Sponsors & Collaborators

  • Korea University Anam Hospital

    lead OTHER

Principal Investigators

  • Yoon Tae Jeen · Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea

  • Eun Sun Kim · Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea

  • Woo Jin Lee · Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2012-11-30
Completion
2012-12-31

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01778192 on ClinicalTrials.gov