Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-30 @ 7:06 AM
Study NCT ID:
NCT02619695
Status:
UNKNOWN
Last Update Posted:
2015-12-02
First Post:
2015-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Ketoprofen Gel to Placebo in Mechanical Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-01', 'studyFirstSubmitDate': '2015-11-30', 'studyFirstSubmitQcDate': '2015-12-01', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual analogue scale at 30 minutes', 'timeFrame': '30 minutes'}], 'secondaryOutcomes': [{'measure': 'Adverse effects', 'timeFrame': '30 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ketoprofen', 'gel', 'low back pain', 'emergency department'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '26501533', 'type': 'BACKGROUND', 'citation': 'Friedman BW, Dym AA, Davitt M, Holden L, Solorzano C, Esses D, Bijur PE, Gallagher EJ. Naproxen With Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for Treating Acute Low Back Pain: A Randomized Clinical Trial. JAMA. 2015 Oct 20;314(15):1572-80. doi: 10.1001/jama.2015.13043.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/26501533', 'label': 'Pubmed link'}]}, 'descriptionModule': {'briefSummary': 'Mechanical low back pain is one most important emergency department presentations of patients seeking pain relief. Although parenteral pain killers such as opioids, non-steroidal anti-inflamatuar drugs and paracetamol are used commonly in these patients, application of analgesics in gel forms might be an reasonable alternative to these drugs with fewer adverse effects.', 'detailedDescription': 'Mechanical low back pain is one most important emergency department presentations of patients seeking pain relief. Parenteral pain killers such as opioids, non-steroidal anti-inflamatuar drugs (NSAID) and paracetamol are used commonly in these patients. However, these drugs are not out of adverse effects and can not be used in some patients with diverse comorbidities. Gel forms of NSAIDs are used commonly in the outpatient clinics and shown to be effective in these patients by a Cochrane meta-analysis. However, there is no data on the effect of gel forms of analgesics in ED. The application of analgesics in gel forms might be a reasonable alternative to the paranteral drugs with fewer adverse effects.\n\nThe present study aimed to reveal the effect of ketoprofen gel in patients presented with low back pain to emergency department.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mechanical low back pain\n\nExclusion Criteria:\n\n* Under 18 years old\n* Over 65 years old\n* Pain less than 40 mm in visual analogue scale\n* Allergy to the study drug\n* Drug or alcohol addiction\n* Pregnancy and lactation'}, 'identificationModule': {'nctId': 'NCT02619695', 'briefTitle': 'Comparison of Ketoprofen Gel to Placebo in Mechanical Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Akdeniz University'}, 'officialTitle': 'Comparison of Ketoprofen Gel to Placebo in Patients Presented With Mechanical Low Back Pain to the Emergency Department: A Randomized Placebo Controlled Trial', 'orgStudyIdInfo': {'id': '2015/08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketoprofen', 'description': 'Interventional arm: ketoprofen gel 2.5% ketoprofen gel (Fastjel) has been administer as 2 gr in 5 cm area.', 'interventionNames': ['Drug: Fastjel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo arm: placebo gel form of ketoprofen', 'interventionNames': ['Drug: Fastjel']}], 'interventions': [{'name': 'Fastjel', 'type': 'DRUG', 'description': '2.5% ketoprofen gel (Fastjel) has been administer as 2 gr in 5 cm area.', 'armGroupLabels': ['Ketoprofen', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Denizli', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Mustafa Serinken', 'role': 'CONTACT', 'email': 'aserinken@hotmail.com'}, {'name': 'Aysel Ozkan', 'role': 'CONTACT', 'email': 'karek@pau.edu.tr'}], 'facility': 'Pamukkale University', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}], 'centralContacts': [{'name': 'Mustafa Serinken, Professor', 'role': 'CONTACT', 'email': 'aserinken@hotmail.com'}, {'name': 'aysel ozkan', 'role': 'CONTACT', 'email': 'karek@pau.edu.tr'}], 'overallOfficials': [{'name': 'Mustafa Serinken, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pamukkale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akdeniz University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pamukkale University', 'class': 'OTHER'}, {'name': 'Celal Bayar University', 'class': 'OTHER'}, {'name': 'Kocatepe University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}