Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-07 @ 8:43 PM
Study NCT ID:
NCT01631669
Status:
UNKNOWN
Last Update Posted:
2012-07-03
First Post:
2012-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Celecoxib for Primary Prophylaxis of Combat-Related Heterotopic Ossification
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009999', 'term': 'Ossification, Heterotopic'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-06-29', 'studyFirstSubmitDate': '2012-06-27', 'studyFirstSubmitQcDate': '2012-06-27', 'lastUpdatePostDateStruct': {'date': '2012-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial', 'timeFrame': '3 years', 'description': 'Incidence and severity of HO'}], 'secondaryOutcomes': [{'measure': 'Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial', 'timeFrame': '3 years', 'description': '1. Overall rate of impaired wound healing.\n2. Overall time to fracture union (if applicable)\n3. Overall rate of nonunions (if applicable)\n4. Overall rate of drug-related complications'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ossification', 'Heterotopic Ossification'], 'conditions': ['Ossification, Heterotopic']}, 'referencesModule': {'references': [{'pmid': '19411456', 'type': 'BACKGROUND', 'citation': 'Forsberg JA, Pepek JM, Wagner S, Wilson K, Flint J, Andersen RC, Tadaki D, Gage FA, Stojadinovic A, Elster EA. Heterotopic ossification in high-energy wartime extremity injuries: prevalence and risk factors. J Bone Joint Surg Am. 2009 May;91(5):1084-91. doi: 10.2106/JBJS.H.00792.'}, {'pmid': '17332095', 'type': 'BACKGROUND', 'citation': 'Potter BK, Burns TC, Lacap AP, Granville RR, Gajewski DA. Heterotopic ossification following traumatic and combat-related amputations. Prevalence, risk factors, and preliminary results of excision. J Bone Joint Surg Am. 2007 Mar;89(3):476-86. doi: 10.2106/JBJS.F.00412.'}]}, 'descriptionModule': {'briefSummary': 'Hypotheses:\n\nH1: Celecoxib, when given less than five days after injury will result in a statistical decrease in the incidence and/or severity of radiographically apparent Heterotopic Ossification when compared to controls.\n\nH2a: A biomarker profile will accurately predict which patients in the treatment group will respond to Celecoxib prophylaxis for Heterotopic Ossification.\n\nH2b: A biomarker profile will accurately predict which patients in the control group are at highest risk of developing Heterotopic Ossification', 'detailedDescription': 'This study is a prospective, randomized, controlled clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ISS ≥9 (a traumatic trans-tibial amputation is an ISS of 9)\n2. Extremity Wound ≥75cm2 requiring operative intervention\n3. Minimal age of 18 years\n\nExclusion Criteria:\n\nThe following co-morbidities will result in exclusion from study:\n\n1. Coronary Artery Disease,\n2. Diabetes Mellitus (IDDM or T2DM),\n3. Peripheral Vascular Disease,\n4. Age \\>65,\n5. Connective tissue disorders,\n6. Immunosuppression,\n7. Clinically-evident peptic ulcer disease,\n8. Substantial renal dysfunction (as assessed by a serum creatinine \\>1.5 or calculated creatinine clearance of \\<50),\n9. Spine-injured patients who have recently received or are going to receive spinal fusion as determined by the evaluating neurosurgeon or orthopaedic spine surgeon at LRMC,\n10. Severe penetrating or hemorrhagic traumatic brain injury,\n11. Endoscopic gastrointestinal interventions,\n12. Pregnancy or women of childbearing who does not take a pregnancy test and effective method of birth control.\n13. Known hypersensitivity to Celebrex, Aspirin, other NSAIDs, or Sulfonamides.\n14. History od Asthma, Urticaria, or allergic-type reactions after taking Aspirin or other NSAIDs.\n15. Hepatic Impairment\n16. Warfarin\n17. Lithium\n18. Drugs known to inhibit CYP2C9 Liver Enzymes\n19. Subjects known or suspected to be poor CYP2C9 metabolizers\n20. Concomitant use with ACE Inhibitors and Angiotension II Antagonists'}, 'identificationModule': {'nctId': 'NCT01631669', 'briefTitle': 'Celecoxib for Primary Prophylaxis of Combat-Related Heterotopic Ossification', 'organization': {'class': 'FED', 'fullName': 'Walter Reed National Military Medical Center'}, 'officialTitle': 'Prophylaxis of Heterotopic Ossification (HO) in Wartime Extremity Injuries, a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '352511'}, 'secondaryIdInfos': [{'id': '110587', 'type': 'OTHER', 'domain': 'FDA IND'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Celebrex', 'description': 'Receive Celebrex', 'interventionNames': ['Drug: Celecoxib']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'no placebo administered'}], 'interventions': [{'name': 'Celecoxib', 'type': 'DRUG', 'otherNames': ['Celebrex'], 'description': '200 mg Q 12 hours orally', 'armGroupLabels': ['Celebrex']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20889', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jonathan A Forsberg, MD', 'role': 'CONTACT', 'email': 'jonathan.forsberg@med.navy.mil', 'phone': '301-319-3403'}, {'name': 'Frederick A Gage', 'role': 'CONTACT', 'email': 'frederick.gage@med.navy.mil', 'phone': '301-319-8592'}, {'name': 'Jonathan A Forsberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Benjamin K Potter, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Eric A Elster, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Frederick A Gage', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Felipe Lisboa, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tala Ghadimi, BS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Walter Reen National Military Medical Center Bethesda', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'city': 'Landstuhl', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Brett Freedman, MD', 'role': 'CONTACT', 'email': 'brett.freedman@amedd.army.mil'}, {'name': 'Brett Freedman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hunter Martin, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Landstuhl Military Medical Center', 'geoPoint': {'lat': 49.41306, 'lon': 7.57021}}], 'centralContacts': [{'name': 'Jonathan A Forsberg, MD', 'role': 'CONTACT', 'email': 'jonathan.forsberg@med.navy.mil', 'phone': '301-319-3403'}, {'name': 'Frederick A Gage', 'role': 'CONTACT', 'email': 'frederick.gage@med.navy.mil', 'phone': '301-319-8592'}], 'overallOfficials': [{'name': 'Jonathan A Forsberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Walter Reed National Military Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Walter Reed National Military Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}