Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2025-12-24 @ 12:00 PM
Study NCT ID:
NCT03520361
Status:
UNKNOWN
Last Update Posted:
2018-06-20
First Post:
2017-08-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between OSS and 2L PEG/Asc for Bowel Preparation of Elderly People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Single Blind (Investigator)'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 198}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2017-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-18', 'studyFirstSubmitDate': '2017-08-20', 'studyFirstSubmitQcDate': '2018-04-26', 'lastUpdatePostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bowel preparation scale of right/transverse/left colon using Boston bowel preparation scale (BPPS)', 'timeFrame': '3 months', 'description': 'The BBPS assesses cleanliness of 3 segments of the colon (ascending, transverse, and descending colon), and the total is a 10-point scale (0-9) that grades each segment of the colon from 0 to 3. In this study, adequate bowel preparation is defined as a total score 6 points or higher and individual score of 2 points or higher in each segment.'}], 'secondaryOutcomes': [{'measure': "Subject's satisfaction based on the 10-point visual analog scale", 'timeFrame': '3 months', 'description': 'The 10-point scale from 0 to 10'}, {'measure': 'Number of subjects who have a difficulty taking solution based on the 5-grade scale', 'timeFrame': '3 months', 'description': 'The 5-grade scale: very easy, easy, moderate, hard, and very hard'}, {'measure': 'Taste of recommended bowel preparation agent based on the 5-grade scale', 'timeFrame': '3 months', 'description': 'The 5-grade scale: very good, good, neutral, bad, and very bad'}, {'measure': 'Number of subjects who have a willingness to repeat the same regimen', 'timeFrame': '3 months', 'description': 'using questionnaires: yes, no'}, {'measure': 'Rate of subjects with nausea', 'timeFrame': '3 months', 'description': 'using questionnaires: yes, no'}, {'measure': 'Rate of subjects with vomiting', 'timeFrame': '3 months', 'description': 'using questionnaires: yes, no'}, {'measure': 'Rate of subjects with abdominal pain', 'timeFrame': '3 months', 'description': 'using questionnaires: yes, no'}, {'measure': 'Rate of subjects with abdominal distention', 'timeFrame': '3 months', 'description': 'using questionnaires: yes, no'}, {'measure': 'Rate of subjects with thirst', 'timeFrame': '3 months', 'description': 'using questionnaires: yes, no'}, {'measure': 'Rate of subjects with dizziness', 'timeFrame': '3 months', 'description': 'using questionnaires: yes, no'}, {'measure': 'Rate of subjects with paresthesia', 'timeFrame': '3 months', 'description': 'using questionnaires: yes, no'}, {'measure': 'Sodium level in mmol/L', 'timeFrame': 'an average of 1 year', 'description': 'change in electrolyte values before and after bowel preparation'}, {'measure': 'Potassium level in mmol/L', 'timeFrame': '3 months', 'description': 'change in electrolyte values before and after bowel preparation'}, {'measure': 'Chloride level in mmol/L', 'timeFrame': '3 months', 'description': 'change in electrolyte values before and after bowel preparation'}, {'measure': 'Magnesium level in mg/dL', 'timeFrame': '3 months', 'description': 'change in electrolyte values before and after bowel preparation'}, {'measure': 'Phosphorus level in mg/dL', 'timeFrame': '3 months', 'description': 'change in electrolyte values before and after bowel preparation'}, {'measure': 'Calcium level in mg/dL', 'timeFrame': '3 months', 'description': 'change in electrolyte values before and after bowel preparation'}, {'measure': 'Blood urea nitrogen level in mg/dL', 'timeFrame': '3 months', 'description': 'change in electrolyte values before and after bowel preparation'}, {'measure': 'Creatinine level in mg/dL', 'timeFrame': '3 months', 'description': 'change in electrolyte values before and after bowel preparation'}, {'measure': 'Serum osmolarity in mmol/kg', 'timeFrame': '3 months', 'description': 'change in osmolarity values before and after bowel preparation'}, {'measure': 'Urine osmolarity in mmol/L', 'timeFrame': '3 months', 'description': 'change in osmolarity values before and after bowel preparation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colonoscopy', 'Bowel preparation', 'Oral sulfate solution', 'Polyethylene glycol', 'Ascorbic acid'], 'conditions': ['Colonoscopy']}, 'descriptionModule': {'briefSummary': 'For evaluation of the usefulness of oral sulfate solution (OSS) for bowel preparation of elderly people, investigators compare the efficacy, tolerability and safety between OSS and 2L polyethylene glycol (PEG) with ascorbic acid (Asc).', 'detailedDescription': 'This study is a multicenter, prospective, randomized parallel arm, investigator initiated trial.\n\nThe aim of study is to compare oral sulfate solution (OSS) with 2L polyethylene glycol (PEG) with ascorbic acid (Asc) for bowel preparation in elderly people.\n\n99 participants will be enrolled in each group (198 in total). The primary outcome is the efficacy of bowel preparation. Secondary outcomes are tolerability, satisfaction, and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Colonoscopy examinee aged 65-80\n* Examinee agree with informed consent\n\nExclusion Criteria:\n\n* Cognitive disorder, mental retardation\n* Bowel obstruction\n* Severe constipation (\\<3 bowel movements per week with or without regular or intermittent laxatives)\n* History of bowel surgery\n* Liver cirrhosis or ascites\n* Heart failure, cardiac disease (ischemic heart disease or coronary artery disease within the last 6 months)\n* Inflammatory bowel disease\n* Pregnancy, lactating woman\n* Renal impairment or history of impaired renal function\n* History of hypersensitivity reaction to bowel preparation'}, 'identificationModule': {'nctId': 'NCT03520361', 'briefTitle': 'Comparison Between OSS and 2L PEG/Asc for Bowel Preparation of Elderly People', 'organization': {'class': 'OTHER', 'fullName': 'KangWon National University Hospital'}, 'officialTitle': 'Comparative Evaluation of the Efficacy of Oral Sulfate Solution (OSS) and 2L Polyethylene Glycol (PEG) With Ascorbic Acid (Asc) for Bowel Preparation of Elderly People: A Multicenter Prospective Randomized Study', 'orgStudyIdInfo': {'id': '2017-03-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral sulfate solution (OSS) taking group', 'description': 'On the evening before colonoscopy, drink 177ml of OSS (Suclear®) (473ml including water in container), additionally allow another 946 ml of water. On the day of colonoscopy, drink 177ml of OSS (473ml including water in container), additionally allow another 946 ml of water.', 'interventionNames': ['Drug: Oral sulfate solution (OSS)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2L PEG/Asc taking group', 'description': 'On the evening before colonoscopy, drink 1L of 2L PEG/Asc (Haprep®) solution, additionally allow another 500 ml of water. On the day of colonoscopy, drink 1L of 2L PEG/Asc solution, additionally allow another 500 ml of water.', 'interventionNames': ['Drug: 2L PEG/Asc']}], 'interventions': [{'name': 'Oral sulfate solution (OSS)', 'type': 'DRUG', 'otherNames': ['Suclear® solution (Phambio Korea, Seoul, Korea)'], 'description': 'Compositions/177ml : Sodium sulfate 17.5g, Potassium sulfate 3.13g, Magnesium sulfate 1.6g', 'armGroupLabels': ['Oral sulfate solution (OSS) taking group']}, {'name': '2L PEG/Asc', 'type': 'DRUG', 'otherNames': ['Haprep® powder (Phambio Korea, Seoul, Korea)'], 'description': 'Compositions/1L : Sodium chloride 2.89g, Potassium chloride 1.015g, Anhydrous sodium sulfate 7.5g, Polyethylene glycol 3350 100g, Ascorbic acid 4.7g, Sodium ascorbate 5.9g', 'armGroupLabels': ['2L PEG/Asc taking group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24289', 'city': 'Chuncheon', 'state': 'Gangwon-do', 'country': 'South Korea', 'facility': 'Kangwon National University Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}], 'overallOfficials': [{'name': 'Sung Chul Park, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KangWon National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KangWon National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}