Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-04-09 @ 9:06 AM
Study NCT ID:
NCT01665157
Status:
COMPLETED
Last Update Posted:
2014-04-02
First Post:
2012-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Acceptability of Low-Residue Diet Package (Enimaclin®) as Diet Control Before Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hanmochiu@ntu.edu.tw', 'title': 'Han-Mo Chiu, M.D., Ph.D.', 'organization': 'National Taiwan University Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Low-residue Diet Package', 'description': 'Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS', 'otherNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Self-controlled Diet', 'description': 'Self-controlled diet with normal amount 2L PEG-ELS', 'otherNumAtRisk': 60, 'otherNumAffected': 1, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Low-residue Diet Package Plus 1.5L PEG-ELS', 'description': 'Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS', 'otherNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'notes': 'Mild abdominal pain noted after bowel preparation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Cleansing Level at Colonoscopy by Ottawa Bowel Preparation Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-residue Diet Package and 2L PEG', 'description': 'Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS'}, {'id': 'OG001', 'title': 'Self-controlled Diet and 2L PEG', 'description': 'Self-controlled diet with normal amount 2L PEG-ELS'}, {'id': 'OG002', 'title': 'Low-residue Diet Package Plus 1.5L PEG', 'description': 'Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS'}], 'classes': [{'categories': [{'measurements': [{'value': '2.58', 'spread': '2.15', 'groupId': 'OG000'}, {'value': '3.22', 'spread': '3.08', 'groupId': 'OG001'}, {'value': '2.97', 'spread': '2.79', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.435', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'Not significant', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'Ottawa preparation scale: Colon is defined into 3 segments: Right(cecum, ascending), mid(transverse, descending), rectosigmoid. Each is scored from 0 to 4, 0 is best and 4 is worst. Fluid quantity of whole is scored as 0, small; 1, moderate; 2 large amount. The scale will be summation of the clearness of 3 segments of colon and overall fluid quantity. It ranged from 0 to 14, 0 is the most clean colon and 14 is the most dirty one. Segment score will be analyzed separately as continuous variable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Overall Cleansing Level at Colonoscopy by Aronchick Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-residue Diet Package and 2L PEG', 'description': 'Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS'}, {'id': 'OG001', 'title': 'Self-controlled Diet and 2L PEG', 'description': 'Self-controlled diet with normal amount 2L PEG-ELS'}, {'id': 'OG002', 'title': 'Low-residue Diet Package Plus 1.5L PEG-ELS', 'description': 'Low-residue diet package(Enimaclin) with reduced volume low volume 1.5L PEG-ELS'}], 'classes': [{'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000'}, {'value': '76.7', 'groupId': 'OG001'}, {'value': '78.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.046', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.024', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Null hypothesis: "Low-residue diet package and 2L PEG" vs. "Self-controlled diet and 2L PEG" provides same preparation quality.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.041', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'The overall proportion of participants scored as Excellent or Good by Aronchick scale.\n\nDescription of Aronchick scale:It categorized colon cleansing into 5 level: Excellent, good, fair, poor, inadequate. It is categorical and cannot be summed. We will present', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Willingness to Choose the Same Protocol After Different Low Residual Diet and PEG-ELS Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-residue Diet Package and 2L PEG', 'description': 'Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS'}, {'id': 'OG001', 'title': 'Self-controlled Diet and 2L PEG', 'description': 'Self-controlled diet with normal amount 2L PEG-ELS'}, {'id': 'OG002', 'title': 'Low-residue Diet Package and 1.5L PEG', 'description': 'Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS'}], 'classes': [{'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000'}, {'value': '90.0', 'groupId': 'OG001'}, {'value': '95.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'It represent the proportion of participants who wanted to choose the same protocol as they received in this trial.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Total Volume of Purgatives That Ingested', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-residue Diet Package and 2L PEG', 'description': 'Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS'}, {'id': 'OG001', 'title': 'Self-controlled Diet and 2L PEG', 'description': 'Self-controlled diet with normal amount 2L PEG-ELS'}, {'id': 'OG002', 'title': 'Low-residue Diet Package and 1.5L PEG', 'description': 'Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS'}], 'classes': [{'categories': [{'measurements': [{'value': '1.96', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '1.98', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '1.61', 'spread': '0.27', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'The total volume of PEG-ELS (Liter) that ingested or could be ingested by examinee before colonoscopy', 'unitOfMeasure': 'Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-residue Diet Package and 2L PEG', 'description': 'Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS'}, {'id': 'OG001', 'title': 'Self-controlled Diet and 2L PEG', 'description': 'Self-controlled diet with normal amount 2L PEG-ELS'}, {'id': 'OG002', 'title': 'Low-residue Diet Package and 1.5 L PEG-ELS', 'description': 'Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS'}], 'classes': [{'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000'}, {'value': '36.7', 'groupId': 'OG001'}, {'value': '76.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'It represented the percentage of participants who is satisfied with the protocol.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Convenience of Different Low Residual Diet and Bowel Preparation Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-residue Diet Package and 2L PEG', 'description': 'Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS'}, {'id': 'OG001', 'title': 'Self-controlled Diet and 2L PEG', 'description': 'Self-controlled diet with 2L PEG-ELS'}, {'id': 'OG002', 'title': 'Low-residue Diet Package and 1.5L PEG', 'description': 'Low-residue diet package(Enimaclin) with reduced volume 1.5L PEG-ELS'}], 'classes': [{'categories': [{'measurements': [{'value': '88.3', 'groupId': 'OG000'}, {'value': '76.7', 'groupId': 'OG001'}, {'value': '93.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'It represented the percentage of participants who thinks the protocol is easy to use.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Segmental Cleansing Level at Colonoscopy (Right Segment Preparation Failure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-residue Diet Package and 2L PEG', 'description': 'Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS'}, {'id': 'OG001', 'title': 'Self-controlled Diet and 2L PEG', 'description': 'Self-controlled diet with normal amount 2L PEG-ELS'}, {'id': 'OG002', 'title': 'Low-residue Diet Package Plus 1.5L PEG', 'description': 'Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '15.0', 'groupId': 'OG001'}, {'value': '6.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.025', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'Segmental score of Ottawa bowel preparation scale was analyzed. The proportion of "right segment" preparation failure, defined as segmental score as "3 poor" or "4 inadequate", was presented.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low-residue Diet Package and 2L PEG', 'description': 'Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS'}, {'id': 'FG001', 'title': 'Self-controlled Diet and 2L PEG', 'description': 'Self-controlled diet with normal amount 2L PEG-ELS'}, {'id': 'FG002', 'title': 'Low-residue Diet Package and 1.5L PEG-ELS', 'description': 'Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment period: 14 months Recruitment location: GI outpatient clinic'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Low-residue Diet Package (Enimaclin®) and 2L PEG', 'description': 'Low-residue diet package with normal amount of 2L PEG-ELS'}, {'id': 'BG001', 'title': 'Self-controlled Diet and 2L PEG', 'description': 'Self-controlled diet with normal amount of 2L PEG-ELS'}, {'id': 'BG002', 'title': 'Low-residue Diet (Enimaclin®) Package and 1.5L PEG', 'description': 'Low-residue diet package with normal amount of 1.5L PEG-ELS'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '157', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.5', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '51.3', 'spread': '12.7', 'groupId': 'BG001'}, {'value': '53.0', 'spread': '11.0', 'groupId': 'BG002'}, {'value': '52.3', 'spread': '11.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-18', 'studyFirstSubmitDate': '2012-02-27', 'resultsFirstSubmitDate': '2013-02-21', 'studyFirstSubmitQcDate': '2012-08-13', 'lastUpdatePostDateStruct': {'date': '2014-04-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-17', 'studyFirstPostDateStruct': {'date': '2012-08-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Cleansing Level at Colonoscopy by Ottawa Bowel Preparation Scale', 'timeFrame': '1 day', 'description': 'Ottawa preparation scale: Colon is defined into 3 segments: Right(cecum, ascending), mid(transverse, descending), rectosigmoid. Each is scored from 0 to 4, 0 is best and 4 is worst. Fluid quantity of whole is scored as 0, small; 1, moderate; 2 large amount. The scale will be summation of the clearness of 3 segments of colon and overall fluid quantity. It ranged from 0 to 14, 0 is the most clean colon and 14 is the most dirty one. Segment score will be analyzed separately as continuous variable.'}, {'measure': 'Overall Cleansing Level at Colonoscopy by Aronchick Scale', 'timeFrame': '1 day', 'description': 'The overall proportion of participants scored as Excellent or Good by Aronchick scale.\n\nDescription of Aronchick scale:It categorized colon cleansing into 5 level: Excellent, good, fair, poor, inadequate. It is categorical and cannot be summed. We will present'}, {'measure': 'Total Volume of Purgatives That Ingested', 'timeFrame': '1 day', 'description': 'The total volume of PEG-ELS (Liter) that ingested or could be ingested by examinee before colonoscopy'}, {'measure': 'Segmental Cleansing Level at Colonoscopy (Right Segment Preparation Failure)', 'timeFrame': '1 day', 'description': 'Segmental score of Ottawa bowel preparation scale was analyzed. The proportion of "right segment" preparation failure, defined as segmental score as "3 poor" or "4 inadequate", was presented.'}], 'secondaryOutcomes': [{'measure': 'Willingness to Choose the Same Protocol After Different Low Residual Diet and PEG-ELS Protocol', 'timeFrame': '1 day', 'description': 'It represent the proportion of participants who wanted to choose the same protocol as they received in this trial.'}, {'measure': 'Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol', 'timeFrame': '1 day', 'description': 'It represented the percentage of participants who is satisfied with the protocol.'}, {'measure': 'Convenience of Different Low Residual Diet and Bowel Preparation Protocol', 'timeFrame': '1 day', 'description': 'It represented the percentage of participants who thinks the protocol is easy to use.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diet Control before Colonoscopy'], 'conditions': ['Dietary Modification']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and the acceptability of low-residue diet package (Enimaclin®) as diet control before colonoscopy.', 'detailedDescription': 'In this study, we investigate a randomized, single-blinded, comparative study to evaluate the efficacy and the acceptability of low-residue diet package (Enimaclin®) as diet control before colonoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female\n* Outpatient or healthy volunteer for health examination, 20\\~75 years old\n* Eligible for oral bowel preparation\n* BMI (Body Mass Index) ≤ 30\n\nExclusion Criteria:\n\n* Patients with severe constipation (as fewer than three stools per week)\n* Patients with bowel obstruction\n* Patients contraindicated with treatment drug\n* Patients who need emergency medication\n* Ineligible for bowel preparation\n* Pregnant or breast-feeding\n* Patients with known allergies to treatment drug or low-residue diet package\n* Patients who are ineligible to enroll'}, 'identificationModule': {'nctId': 'NCT01665157', 'briefTitle': 'Efficacy and Acceptability of Low-Residue Diet Package (Enimaclin®) as Diet Control Before Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'A Randomized, Single-blinded, Comparative Study to Evaluate the Efficacy and the Acceptability of Low-residue Diet Package (Enimaclin®) as Diet Control Before Colonoscopy', 'orgStudyIdInfo': {'id': 'NTUH201109018RD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low-residue diet package (Enimaclin®)', 'description': 'Low-residue diet package with normal amount 2L PEG-ELS', 'interventionNames': ['Dietary Supplement: Enimaclin®', 'Drug: 2L PEG-ELS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Self-controlled diet', 'description': 'Self-controlled diet with normal amount of 2L PEG-ELS', 'interventionNames': ['Other: Self-controlled diet', 'Drug: 2L PEG-ELS']}, {'type': 'EXPERIMENTAL', 'label': 'Low-residue diet (Enimaclin®) package', 'description': 'Low-residue diet package with low volume 1.5L PEG-ELS', 'interventionNames': ['Dietary Supplement: Enimaclin®', 'Drug: low volume 1.5L PEG-ELS']}], 'interventions': [{'name': 'Enimaclin®', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Enimaclin Colomil ®,a low-residue diet package'], 'description': 'Enimaclin Colomil ® (Glico Co., Japan Osaka)，a low-residue diet package for each meal.\n\nThe duration of study is one day before colonoscopy.', 'armGroupLabels': ['Low-residue diet (Enimaclin®) package', 'low-residue diet package (Enimaclin®)']}, {'name': 'Self-controlled diet', 'type': 'OTHER', 'otherNames': ['Self-controlled low residue diet.'], 'description': 'Self-controlled low residue diet.', 'armGroupLabels': ['Self-controlled diet']}, {'name': '2L PEG-ELS', 'type': 'DRUG', 'otherNames': ['Taiwan name: Niflec powder'], 'description': 'Normal volume of PEG-ELS', 'armGroupLabels': ['Self-controlled diet', 'low-residue diet package (Enimaclin®)']}, {'name': 'low volume 1.5L PEG-ELS', 'type': 'DRUG', 'otherNames': ['Taiwan name: Niflec powder'], 'description': 'Low volume PEG-ELS', 'armGroupLabels': ['Low-residue diet (Enimaclin®) package']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kaohsiung', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'E-Da Hospital'}, {'city': 'Taipei', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital Bei-Hu Branch', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'Taipei Medical University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Han-Mo Chiu, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NTUH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}