Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-29 @ 11:39 AM
Study NCT ID:
NCT00910832
Status:
COMPLETED
Last Update Posted:
2014-03-19
First Post:
2009-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Eductyl® Versus Placebo for Treatment of Dyschesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 306}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-18', 'studyFirstSubmitDate': '2009-05-29', 'studyFirstSubmitQcDate': '2009-05-29', 'lastUpdatePostDateStruct': {'date': '2014-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia treated by rectal rehabilitation on VAS of intensity of symptoms', 'timeFrame': 'Day -7, 0, 3, 7, 10, 14, 17, and 21'}], 'secondaryOutcomes': [{'measure': 'To assess the efficacy on change symptoms and safety of Eductyl versus placebo for treatment of patients with dyschesia treated by rectal rehabilitation', 'timeFrame': 'Day 0 and 21'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dyschesia treatment', 'Rehabilitation', 'Dyschesia'], 'conditions': ['Dyschesia']}, 'referencesModule': {'references': [{'pmid': '24807604', 'type': 'DERIVED', 'citation': 'Cotelle O, Cargill G, Marty MM, Bueno L, Cappelletti MC, Colangeli-Hagege H, Savarieau B, Ducrotte P. A concomitant treatment by CO2-releasing suppositories improves the results of anorectal biofeedback training in patients with dyschezia: results of a randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2014 Jun;57(6):781-9. doi: 10.1097/DCR.0000000000000098.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia treated by rectal rehabilitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female over 18 years\n* Patients with dyschesia\n* Prescription of rehabilitation for dyschesia\n\nExclusion Criteria:\n\n* Rectal diseases\n* Pain killers\n* Pregnant women\n* Breast feeding patients\n* Non-compliant patients'}, 'identificationModule': {'nctId': 'NCT00910832', 'acronym': 'Eductyl', 'briefTitle': 'Efficacy of Eductyl® Versus Placebo for Treatment of Dyschesia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires Techni Pharma'}, 'officialTitle': 'Comparative, Randomized, Double-blind Study of the Efficacy of Eductyl® Versus Placebo for Treatment of Patients With Dyschesia Treated by Rectal Rehabilitation', 'orgStudyIdInfo': {'id': '07-EDU-01'}, 'secondaryIdInfos': [{'id': 'EudraCT N° : 2007-0003658-27'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eductyl suppository', 'interventionNames': ['Drug: Eductyl suppository']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo suppository', 'interventionNames': ['Drug: Placebo suppository']}], 'interventions': [{'name': 'Eductyl suppository', 'type': 'DRUG', 'description': 'one suppository every morning during 21 days', 'armGroupLabels': ['Eductyl suppository']}, {'name': 'Placebo suppository', 'type': 'DRUG', 'description': 'placebo suppository every morning during 21 days', 'armGroupLabels': ['Placebo suppository']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Diaconesses Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Odile Cotelle, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diaconesses hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires Techni Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}