Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-26 @ 4:18 PM
Study NCT ID:
NCT00226759
Status:
COMPLETED
Last Update Posted:
2012-10-12
First Post:
2005-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of OMS103HP in Patients Undergoing Allograft Anterior Cruciate Ligament (ACL) Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007718', 'term': 'Knee Injuries'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C530310', 'term': 'OMS 103HP'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 321}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'dispFirstSubmitDate': '2012-10-10', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-10', 'studyFirstSubmitDate': '2005-09-26', 'dispFirstSubmitQcDate': '2012-10-10', 'studyFirstSubmitQcDate': '2005-09-26', 'dispFirstPostDateStruct': {'date': '2012-10-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in knee function', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Decreased pain', 'timeFrame': '30 days'}, {'measure': 'Improved range of motion', 'timeFrame': '30 days'}, {'measure': 'Earlier return to work', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anterior cruciate ligament reconstruction', 'ACL reconstruction'], 'conditions': ['Knee Injuries']}, 'descriptionModule': {'briefSummary': 'The anterior cruciate ligament (ACL) is an important stabilizer of the knee. Orthopedic surgeons replace the torn ligament during ACL reconstruction surgery. Surgical trauma initiates an acute inflammatory response, including swelling and pain, that leads to restricted joint motion and loss of function. OMS103HP was designed to deliver targeted therapeutic agents directly to the surgical site during the arthroscopic procedure to inhibit inflammation and pain before they can begin.\n\nThe purpose of this study is to assess the effectiveness and safety of OMS103HP in improving knee function following ACL reconstruction. Secondary benefits being evaluated include reduced postoperative pain, improvement in knee range of motion and earlier return to work.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 15 - 65 years of age\n* In good general health with an ACL tear that occurred from 2 weeks to 18 months prior to the day of arthroscopic surgery\n* Undergoing primary unilateral ACL reconstruction using an allograft (patellar tendon bone, Achilles tendon, tibialis tendon, or hamstring)\n* Able to participate in the study rehabilitation protocol\n* and other inclusion criteria\n\nExclusion Criteria:\n\n* No allergies to any of the individual ingredients in OMS103HP\n* No medications with the same activities as that of the active ingredients in OMS103HP for defined time intervals prior to and after surgery\n* No associated knee injuries likely to interfere with evaluation of the study drug\n* and other exclusion criteria'}, 'identificationModule': {'nctId': 'NCT00226759', 'briefTitle': 'Efficacy and Safety of OMS103HP in Patients Undergoing Allograft Anterior Cruciate Ligament (ACL) Reconstruction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Omeros Corporation'}, 'officialTitle': 'Double-Blind, Multicenter Phase 3 Study Comparing the Efficacy and Safety of OMS103HP With Vehicle in Patients Undergoing Allograft ACL Reconstruction', 'orgStudyIdInfo': {'id': 'C03511'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OMS103HP irrigation solution', 'description': 'Drug', 'interventionNames': ['Drug: OMS103HP']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'vehicle irrigation solution', 'description': 'Vehicle', 'interventionNames': ['Drug: Vehicle']}], 'interventions': [{'name': 'OMS103HP', 'type': 'DRUG', 'description': 'Maximum of 39 liters of OMS103HP irrigation solution over a maximum of 2 hours.', 'armGroupLabels': ['OMS103HP irrigation solution']}, {'name': 'Vehicle', 'type': 'DRUG', 'description': 'Maximum of 39 liters of vehicle irrigation solution over a maximum of 2 hours', 'armGroupLabels': ['vehicle irrigation solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'CORE Orthopaedic Medical Center', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Sports, Orthopedic and Rehabilitation Medicine Associates (S.O.A.R.)', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80110', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Orthopedic Consultants, PC', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '80487', 'city': 'Steamboat Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'American Clinical Research Services', 'geoPoint': {'lat': 40.48498, 'lon': -106.83172}}, {'zip': '32607', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '30350', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Southeastern Center for Clinical Trials', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '55454', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Sports Medicine', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '43221', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '16602', 'city': 'Altoona', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University Orthopedics Center', 'geoPoint': {'lat': 40.51868, 'lon': -78.39474}}, {'zip': '15203', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '16801', 'city': 'State College', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University Orthopedics Center', 'geoPoint': {'lat': 40.79339, 'lon': -77.86}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Orthopedics', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78681', 'city': 'Round Rock', 'state': 'Texas', 'country': 'United States', 'facility': 'Round Rock Orthopedics', 'geoPoint': {'lat': 30.50826, 'lon': -97.6789}}, {'zip': '78217', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Unlimited Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78666', 'city': 'San Marcos', 'state': 'Texas', 'country': 'United States', 'facility': 'Hill Country Sports Medicine', 'geoPoint': {'lat': 29.88327, 'lon': -97.94139}}, {'zip': '23708', 'city': 'Portsmouth', 'state': 'Virginia', 'country': 'United States', 'facility': 'Naval Medical Center - Portsmouth', 'geoPoint': {'lat': 36.83543, 'lon': -76.29827}}, {'zip': '98431', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Madigan Army Medical Center', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': 'L1S 2J5', 'city': 'Ajax', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Rouge Valley Health Systems', 'geoPoint': {'lat': 43.85012, 'lon': -79.03288}}, {'zip': 'N9A 1E1', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hotel Dieu Grace Hospital', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}], 'overallOfficials': [{'name': 'Scott Houston', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Omeros Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Omeros Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}