Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2026-02-28 @ 1:49 AM
Study NCT ID:
NCT00542295
Status:
COMPLETED
Last Update Posted:
2008-10-01
First Post:
2007-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C010846', 'term': 'alverine'}, {'id': 'D012841', 'term': 'Simethicone'}], 'ancestors': [{'id': 'D004129', 'term': 'Dimethylpolysiloxanes'}, {'id': 'D012828', 'term': 'Silicones'}, {'id': 'D012833', 'term': 'Siloxanes'}, {'id': 'D017646', 'term': 'Organosilicon Compounds'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-30', 'studyFirstSubmitDate': '2007-10-10', 'studyFirstSubmitQcDate': '2007-10-10', 'lastUpdatePostDateStruct': {'date': '2008-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subject self assessment of abdominal pain/discomfort', 'timeFrame': 'Baseline and 4 weeks'}], 'secondaryOutcomes': [{'measure': 'IBS life impact, overall treatment assessment, concomitant factors', 'timeFrame': 'Baseline and 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'To assess the effectiveness of alverine citrate and simeticone on IBS symptoms according to the latest recommended design'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female ambulatory patients, aged 18-75 years\n* with IBS as defined by Rome III criteria\n\nExclusion Criteria:\n\n* Functional bowel disorder other than IBS,\n* Underlying cause for symptomatology, which excludes IBS diagnosis,\n* Gastro-intestinal cancer or significant gastro-intestinal surgical background,\n* Any acute/uncontrolled systemic pathology'}, 'identificationModule': {'nctId': 'NCT00542295', 'briefTitle': 'Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires Mayoly Spindler'}, 'officialTitle': 'Efficacy and Safety of Meteospasmyl® in Irritable Bowel Syndrome. a 4-Week, Multicentre, Double-Blind, Randomised, Placebo-Controlled Phase IV Trial', 'orgStudyIdInfo': {'id': 'IMTO601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: alverine citrate and simeticone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'alverine citrate and simeticone', 'type': 'DRUG', 'otherNames': ['Meteospasmyl®'], 'armGroupLabels': ['A']}, {'name': 'placebo', 'type': 'DRUG', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1083', 'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1106', 'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1125', 'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1204', 'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '9024', 'city': 'Győr', 'country': 'Hungary', 'geoPoint': {'lat': 47.68333, 'lon': 17.63512}}, {'zip': '5700', 'city': 'Gyula', 'country': 'Hungary', 'geoPoint': {'lat': 46.65, 'lon': 21.28333}}, {'zip': '3501', 'city': 'Miskolc', 'country': 'Hungary', 'geoPoint': {'lat': 48.10327, 'lon': 20.77806}}, {'zip': '3529', 'city': 'Miskolc', 'country': 'Hungary', 'geoPoint': {'lat': 48.10327, 'lon': 20.77806}}, {'zip': '8600', 'city': 'Siofolk', 'country': 'Hungary'}, {'zip': '6720', 'city': 'Szeged', 'country': 'Hungary', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '8000', 'city': 'Székesfehérvár', 'country': 'Hungary', 'geoPoint': {'lat': 47.18995, 'lon': 18.41034}}, {'zip': '85-168', 'city': 'Bydgoszcz', 'country': 'Poland', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '40-752', 'city': 'Katowice', 'country': 'Poland', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '55-200', 'city': 'Oława', 'country': 'Poland', 'geoPoint': {'lat': 50.9466, 'lon': 17.2926}}, {'zip': '71-252', 'city': 'Szczecin', 'country': 'Poland', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'zip': '50-556', 'city': 'Wroclaw', 'country': 'Poland', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '51-149', 'city': 'Wroclaw', 'country': 'Poland', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'overallOfficials': [{'name': 'Philippe Ducrotte, M.D', 'role': 'STUDY_CHAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires Mayoly Spindler', 'class': 'INDUSTRY'}}}}