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

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ClinicalTrials.gov Identifier: NCT01778192
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : January 31, 2013
Sponsor:
Information provided by (Responsible Party):
Woo-Jin Lee, Korea University Anam Hospital

January 25, 2013
January 29, 2013
January 31, 2013
July 2012
November 2012   (Final data collection date for primary outcome measure)
the quality of the bowel preparation using the Ottawa bowel preparation scale (OBPS) [ Time Frame: 20 minutes ]
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).
Same as current
Complete list of historical versions of study NCT01778192 on ClinicalTrials.gov Archive Site
  • Completeness of the bowel preparation [ Time Frame: 30 minutes before the colonoscopy ]
    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 [ Time Frame: 30 minutes before the colonoscopy ]
    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 [ Time Frame: 1 hour before the colonoscopy ]

    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.

Same as current
Not Provided
Not Provided
 
A Randomized Prospective Trial Comparing Polyethylene Glycol and Sodium Picosulphate With Magnesium Citrate
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

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.

  1. Study design: endoscopist-blinded, prospective, randomized controlled trial
  2. Subjects

    1. Entry criteria: Male or female patients, aged between18 and 75 years undergoing elective outpatient colonoscopy were eligible for the study.
    2. 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.

  3. Sampling design: Consecutive recruitment of consenting patients
  4. Variables Predictor

    1. group 1 (same day PEG) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy
    2. 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
    3. 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;
    4. 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.
  5. Primary Outcome: Quality of bowel preparation (Ottawa scale)
  6. Secondary Outcome: Tolerability, palatability, side effect of the cleansing agents
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
  • Colorectal Cancer
  • Colon Adenoma
  • Drug: Polyethylene glycol
    -group 1 (same day PEG) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy
    Other Name: Colyte(Taejoon Pharmaceuticals, Seoul, Korea)
  • 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
    Other Name: Colyte(Taejoon Pharmaceuticals, Seoul, Korea)
  • 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
    Other Name: Picolight(Pharmbio korea, Seoul, Korea)
  • 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.
    Other Name: Picolight(Pharmbio korea, Seoul, Korea)
  • Active Comparator: Same day PEG
    group 1 (same day PEG, N=50) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy
    Intervention: Drug: Polyethylene glycol
  • Active Comparator: split PEG
    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: Drug: Polyethylene glycol
  • Active Comparator: SPMC 2
    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
    Intervention: Drug: Sodium picosulphate with magnesium citrate
  • Active Comparator: SPMC 3
    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: Drug: Sodium picosulphate with magnesium citrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
Same as current
December 2012
November 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01778192
Korea University
Yes
Not Provided
Not Provided
Woo-Jin Lee, Korea University Anam Hospital
Korea University Anam Hospital
Not Provided
Study Director: Yoon Tae Jeen Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea
Principal Investigator: 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
Korea University Anam Hospital
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP