Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT01626235
Status:
COMPLETED
Last Update Posted:
2014-03-12
First Post:
2012-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AMPED Outcomes Registry of Post-ED Pain Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-01-09', 'releaseDate': '2015-01-04'}], 'estimatedResultsFirstSubmitDate': '2015-01-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D017695', 'term': 'Soft Tissue Injuries'}, {'id': 'D015210', 'term': 'Arthritis, Gouty'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D056844', 'term': 'Renal Colic'}, {'id': 'D004412', 'term': 'Dysmenorrhea'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D007669', 'term': 'Kidney Calculi'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D006073', 'term': 'Gout'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011686', 'term': 'Purine-Pyrimidine Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 843}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-11', 'studyFirstSubmitDate': '2012-06-20', 'studyFirstSubmitQcDate': '2012-06-21', 'lastUpdatePostDateStruct': {'date': '2014-03-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Outcomes of pain control measures', 'timeFrame': '5 days', 'description': '1. Change in pain score over follow-up interval;\n2. Healthcare resource utilization during follow-up interval;\n3. Patient satisfaction with therapy;\n4. Return to work in employed cohort.'}], 'secondaryOutcomes': [{'measure': 'Satisfaction and Economic Outcomes', 'timeFrame': '5 days', 'description': '1. Effectiveness of work upon return;\n2. Relative adverse effect profiles of three treatment regimens;\n3. Compliance with therapy;\n4. QOL at conclusion of therapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pain control', 'fractures', 'sprains', 'strains', 'dysmenorrhea', 'kidney stones', 'gouty arthritis', 'opioids', 'NSDAIDs', 'Emergency Department', 'patient reported outcomes'], 'conditions': ['Soft Tissue Injuries', 'Gouty Arthritis', 'Fractures', 'Ureteral Colic', 'Dysmenorrhea']}, 'descriptionModule': {'briefSummary': 'Study aims to assess patient-recorded outcomes of pain control medications prescribed in the ER after visits for specific painful injuries/illnesses.', 'detailedDescription': "Multicenter, observational, prospective, out-of-hospital registry collecting clinical, satisfaction, quality of life, and healthcare resource utilization from subjects discharged after ED care for a specific acute pain syndrome with a clinician-determined analgesic regimen. Subjects are stratified by diagnosis and by regimen based on the treating clinician's judgment. The registry study is independent of ED care and clinician's decision-making."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'at least 800 patients with specific musculoskeletal or visceral pain syndrome', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible subjects will meet the following criteria:\n\n 1. Eligible diagnoses:\n\n musculoskeletal etiologies: acute extremity fractures sprains/strains acute gouty arthritis visceral etiologies: renal colic dysmenorrhea\n 2. Age GTE 18 years;\n 3. Decision to discharge from ED to community already made;\n 4. Decision to give SPRIX, opioid, OR SPRIX + opioid rescue already made;\n 5. Treating clinician deems patient appropriate for continued analgesic management as an outpatient for the next 3-5 days;\n 6. Patient has ready touch-tone (mobile or land line) telephone access, provides number (and back-up number, if possible) and agrees (verbal or written consent as mandated by site) to answer and comply with brief IVR questionnaires daily for next 4 days.\n\nExclusion Criteria:\n\n* Eligible subjects will meet none of the following criteria:\n\n 1. Patient admitted or placed on observation status from ED;\n 2. Patient unwilling or unable to comply with telephonic follow-up;\n 3. Fracture that requires surgical repair (even if at a later date);\n 4. Patient has diagnosis of any chronic pain syndrome;\n 5. Patient already routinely takes NSAID or opioid agent;\n 6. Treating clinician has reasonable suspicion of drug-seeking behavior or noncompliance;\n 7. Nasal abnormality or illness that could affect the absorption of intranasal medication (such as: nasal discharge, rhinitis, acute upper respiratory infection, acute epistaxis, nasal polyp, nasal tumor).'}, 'identificationModule': {'nctId': 'NCT01626235', 'acronym': 'AMPED', 'briefTitle': 'AMPED Outcomes Registry of Post-ED Pain Management', 'organization': {'class': 'INDUSTRY', 'fullName': 'Radnor Registry Research, Inc'}, 'officialTitle': 'Acute Management of Pain From the Emergency Department: A National, Emergency Department-Based Prospective Post-Intervention Registry of Non-Opioid and Opioid Management of Acute Pain', 'orgStudyIdInfo': {'id': 'RRR-LUIT-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NSAID only', 'description': 'Subjects have their pain treated post-ED care with NSAID medication alone'}, {'label': 'Opioid only', 'description': 'Subjects have their pain treated post-ED care with opioid medication alone'}, {'label': 'NSAID + Opioid', 'description': 'Subjects have their pain treated post-ED care with NSAID medication and opioid as PRN rescue analgesia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'LSU Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '74135', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma HSC', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pennsylvania Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29403', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Ben Taub General Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas HSC at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Charles V Pollack, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}, {'name': 'Knox Todd, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MD Anderson'}, {'name': 'Debra Diercks, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UC Davis'}, {'name': 'Sharon Mace, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Cleveland Clinic'}, {'name': 'Stephen Thomas, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Univ Oklahoma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radnor Registry Research, Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'American Regent, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-01-04', 'type': 'RELEASE'}, {'date': '2015-01-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Radnor Registry Research, Inc'}}}}