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

Primary Purpose

Colorectal Cancer, Colon Adenoma

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Polyethylene glycol
Polyethylene glycol
Sodium picosulphate with magnesium citrate
Sodium picosulphate with magnesium citrate
Sponsored by
Korea University Anam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring Bowel preparation, Polyethylene glycol, Sodium picosulphate

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Same day PEG

split PEG

SPMC 2

SPMC 3

Arm Description

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

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

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

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Completeness of the bowel preparation
Patient compliance was recorded by checking the completeness of the prescribed preparation methods including bowel cleansing agent solution and recommended clear liquid.
the patient's tolerability
Patients were asked with questionnaires about the symptoms associated with the preparation to assess the patients' tolerability before the colonoscopy. Patients were asked whether they experienced any of the following : abdominal fullness, cramping, nausea, vomiting, sleep disturbance, and overall discomfort, and these symptoms were scored on a 5-point scale where 1 = "none", 2 = "mild", 3 = "moderate", 4 = "severe", and 5 = "very severe".
the side effects of the sodium picosulphate and magnesium citrate
Biochemical measures detected outrange of serum electrolytes (sodium, potassium, chloride, calcium, magnesium, and phosphate), blood urea nitrogen, creatinine and serum osmolality only for the sodium picosulphate and magnesium citrate. Biochemical measurement was done done for the patients in the polyethylene glycol groups due to the well established safety date of the polyethylene glycol solutions.

Full Information

First Posted
January 25, 2013
Last Updated
January 29, 2013
Sponsor
Korea University Anam Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01778192
Brief Title
A Randomized Prospective Trial Comparing Polyethylene Glycol and Sodium Picosulphate With Magnesium Citrate
Official Title
A Randomized Prospective Trial Comparing Different Regimens of Polyethylene Glycol-based Lavage and Sodium Picosulphate With Magnesium Citrate in the Preparation of Patients for Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Anam Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Study design: endoscopist-blinded, prospective, randomized controlled trial Subjects Entry criteria: Male or female patients, aged between18 and 75 years undergoing elective outpatient colonoscopy were eligible for the study. Exclusion criteria: 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. Sampling design: Consecutive recruitment of consenting patients Variables Predictor group 1 (same day PEG) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy group 2 (split PEG) 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 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; 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. Primary Outcome: Quality of bowel preparation (Ottawa scale) Secondary Outcome: Tolerability, palatability, side effect of the cleansing agents

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colon Adenoma
Keywords
Bowel preparation, Polyethylene glycol, Sodium picosulphate

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Same day PEG
Arm Type
Active Comparator
Arm Description
group 1 (same day PEG, N=50) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy
Arm Title
split PEG
Arm Type
Active Comparator
Arm Description
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
Arm Title
SPMC 2
Arm Type
Active Comparator
Arm Description
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
Arm Title
SPMC 3
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Polyethylene glycol
Other Intervention Name(s)
Colyte(Taejoon Pharmaceuticals, Seoul, Korea)
Intervention Description
-group 1 (same day PEG) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy
Intervention Type
Drug
Intervention Name(s)
Polyethylene glycol
Other Intervention Name(s)
Colyte(Taejoon Pharmaceuticals, Seoul, Korea)
Intervention Description
-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
Intervention Type
Drug
Intervention Name(s)
Sodium picosulphate with magnesium citrate
Other Intervention Name(s)
Picolight(Pharmbio korea, Seoul, Korea)
Intervention Description
-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
Intervention Type
Drug
Intervention Name(s)
Sodium picosulphate with magnesium citrate
Other Intervention Name(s)
Picolight(Pharmbio korea, Seoul, Korea)
Intervention Description
-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.
Primary Outcome Measure Information:
Title
the quality of the bowel preparation using the Ottawa bowel preparation scale (OBPS)
Description
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).
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Completeness of the bowel preparation
Description
Patient compliance was recorded by checking the completeness of the prescribed preparation methods including bowel cleansing agent solution and recommended clear liquid.
Time Frame
30 minutes before the colonoscopy
Title
the patient's tolerability
Description
Patients were asked with questionnaires about the symptoms associated with the preparation to assess the patients' tolerability before the colonoscopy. Patients were asked whether they experienced any of the following : abdominal fullness, cramping, nausea, vomiting, sleep disturbance, and overall discomfort, and these symptoms were scored on a 5-point scale where 1 = "none", 2 = "mild", 3 = "moderate", 4 = "severe", and 5 = "very severe".
Time Frame
30 minutes before the colonoscopy
Title
the side effects of the sodium picosulphate and magnesium citrate
Description
Biochemical measures detected outrange of serum electrolytes (sodium, potassium, chloride, calcium, magnesium, and phosphate), blood urea nitrogen, creatinine and serum osmolality only for the sodium picosulphate and magnesium citrate. Biochemical measurement was done done for the patients in the polyethylene glycol groups due to the well established safety date of the polyethylene glycol solutions.
Time Frame
1 hour before the colonoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients, aged between18 and 75 years undergoing elective outpatient colonoscopy were eligible for the study Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoon Tae Jeen
Organizational Affiliation
Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eun Sun Kim
Organizational Affiliation
Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Woo Jin Lee
Organizational Affiliation
Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine
City
Seoul
ZIP/Postal Code
ASI|KR|KS013|SEOUL
Country
Korea, Republic of

12. IPD Sharing Statement

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

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