Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-26 @ 6:22 AM
Study NCT ID:
NCT01778192
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
2013-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Prospective Trial Comparing Polyethylene Glycol and Sodium Picosulphate With Magnesium Citrate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011092', 'term': 'Polyethylene Glycols'}, {'id': 'C005701', 'term': 'picosulfate sodium'}, {'id': 'C110422', 'term': 'magnesium citrate'}], 'ancestors': [{'id': 'D005026', 'term': 'Ethylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-29', 'studyFirstSubmitDate': '2013-01-25', 'studyFirstSubmitQcDate': '2013-01-28', 'lastUpdatePostDateStruct': {'date': '2013-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the quality of the bowel preparation using the Ottawa bowel preparation scale (OBPS)', 'timeFrame': '20 minutes', '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).'}], 'secondaryOutcomes': [{'measure': 'Completeness of the bowel preparation', 'timeFrame': '30 minutes before the colonoscopy', 'description': 'Patient compliance was recorded by checking the completeness of the prescribed preparation methods including bowel cleansing agent solution and recommended clear liquid.'}, {'measure': "the patient's tolerability", 'timeFrame': '30 minutes before the colonoscopy', '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".'}, {'measure': 'the side effects of the sodium picosulphate and magnesium citrate', 'timeFrame': '1 hour before the colonoscopy', '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.\n\nBiochemical measurement was done done for the patients in the polyethylene glycol groups due to the well established safety date of the polyethylene glycol solutions.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bowel preparation', 'Polyethylene glycol', 'Sodium picosulphate'], 'conditions': ['Colorectal Cancer', 'Colon Adenoma']}, 'descriptionModule': {'briefSummary': '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.\n\nBowel 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).\n\nThere are rare reports that compare directly conventional polyethylene glycol (PEG) solution and sodium picosulphate with magnesium citrate (SPMC) for bowel preparation in korea.\n\nThe aim of this study is to compare the efficacy, safety, and tolerability of different regimens of SPMC and PEG solution.', 'detailedDescription': '1. Study design: endoscopist-blinded, prospective, randomized controlled trial\n2. Subjects\n\n 1. Entry criteria: Male or female patients, aged between18 and 75 years undergoing elective outpatient colonoscopy were eligible for the study.\n 2. Exclusion criteria:\n\n 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.\n3. Sampling design: Consecutive recruitment of consenting patients\n4. Variables Predictor\n\n 1. group 1 (same day PEG) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy\n 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\n 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;\n 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.\n5. Primary Outcome: Quality of bowel preparation (Ottawa scale)\n6. Secondary Outcome: Tolerability, palatability, side effect of the cleansing agents'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients, aged between18 and 75 years undergoing elective outpatient colonoscopy were eligible for the study\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT01778192', 'briefTitle': 'A Randomized Prospective Trial Comparing Polyethylene Glycol and Sodium Picosulphate With Magnesium Citrate', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Anam Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'Korea University'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Same day PEG', 'description': 'group 1 (same day PEG, N=50) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy', 'interventionNames': ['Drug: Polyethylene glycol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'split PEG', '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', 'interventionNames': ['Drug: Polyethylene glycol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SPMC 2', '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', 'interventionNames': ['Drug: Sodium picosulphate with magnesium citrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SPMC 3', '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.', 'interventionNames': ['Drug: Sodium picosulphate with magnesium citrate']}], 'interventions': [{'name': 'Polyethylene glycol', 'type': 'DRUG', 'otherNames': ['Colyte(Taejoon Pharmaceuticals, Seoul, Korea)'], 'description': '-group 1 (same day PEG) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy', 'armGroupLabels': ['Same day PEG']}, {'name': 'Polyethylene glycol', 'type': 'DRUG', 'otherNames': ['Colyte(Taejoon Pharmaceuticals, Seoul, Korea)'], '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', 'armGroupLabels': ['split PEG']}, {'name': 'Sodium picosulphate with magnesium citrate', 'type': 'DRUG', 'otherNames': ['Picolight(Pharmbio korea, Seoul, Korea)'], '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', 'armGroupLabels': ['SPMC 2']}, {'name': 'Sodium picosulphate with magnesium citrate', 'type': 'DRUG', 'otherNames': ['Picolight(Pharmbio korea, Seoul, Korea)'], '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.', 'armGroupLabels': ['SPMC 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'ASI|KR|KS013|SEOUL', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Yoon Tae Jeen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea'}, {'name': 'Eun Sun Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea'}, {'name': 'Woo Jin Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'fellow', 'investigatorFullName': 'Woo-Jin Lee', 'investigatorAffiliation': 'Korea University Anam Hospital'}}}}