Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-29 @ 3:59 AM
Study NCT ID:
NCT00386269
Status:
COMPLETED
Last Update Posted:
2007-11-29
First Post:
2006-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Double Blind Randomized Study Into the Efficacy of Codeine Phosphate Analgesia After Cleft Palate Repair in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-28', 'studyFirstSubmitDate': '2006-10-10', 'studyFirstSubmitQcDate': '2006-10-10', 'lastUpdatePostDateStruct': {'date': '2007-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose of morphine used within the first 6h after surgery'}], 'secondaryOutcomes': [{'measure': 'Pain scores'}]}, 'conditionsModule': {'keywords': ['codeine phosphate analgesia'], 'conditions': ['Cleft Palate Repair']}, 'descriptionModule': {'briefSummary': 'This study examines the analgesic efficacy of codeine phosphate. It is compared to placebo in infants receiving morphine after surgery. Codeine may be effective enough to make morphine unnecessary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Months', 'minimumAge': '4 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants with cleft palate'}, 'identificationModule': {'nctId': 'NCT00386269', 'briefTitle': 'Double Blind Randomized Study Into the Efficacy of Codeine Phosphate Analgesia After Cleft Palate Repair in Infants', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Child Health'}, 'officialTitle': 'Double Blind Randomized Study Into the Efficacy of Codeine Phosphate Analgesia After Cleft Palate Repair in Infants', 'orgStudyIdInfo': {'id': '02AR53'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Codeine Phosphate Analgesia', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'WC1N 1EH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Great Ormond Street Hospital, Anaesthetics', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Mike Sury, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute Of Child Health and Great Ormond Street Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Child Health', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr Tracy Assari', 'oldOrganization': 'Institute of Child Health'}}}}