Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 7:41 PM
Study NCT ID:
NCT01421433
Status:
UNKNOWN
Last Update Posted:
2012-03-08
First Post:
2011-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Study Between Lysine Clonixinate+Cyclobenzaprine and Caffeine+Carisoprodol+Sodium Diclofenac+Paracetamol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-07', 'studyFirstSubmitDate': '2011-08-18', 'studyFirstSubmitQcDate': '2011-08-19', 'lastUpdatePostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain average reduction', 'timeFrame': '7 days', 'description': 'The metric that will be used is Pain Analog Visual Scale (PAVS), that it is a graphical representation with values 0-10.\n\nTo use the PAVS, the principal investigator should question the patient regarding their pain level, and the value 0 (zero) means no pain and the value 10 (ten) indicates the maximum pain level.'}], 'secondaryOutcomes': [{'measure': 'Identification of possible gastrointestinal effects', 'timeFrame': '7 days', 'description': 'The metric that will be used is checking the safety data reported by the patient in the Patient Diary and / or using data reported by patients by Phone Call.\n\nA diary will be given for the patient, to make notes about possible gastrointestinal adverse events.\n\nThe principal investigator should call to the patient to know about possible gastrointestinal adverse effects of the drug.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Clonixin', 'Anti-Inflammatory Agents, Non-Steroidal', 'Cyclooxygenase Inhibitors', 'Lysine', 'L-Lysine', 'Lysine Acetate', 'Lysine Hydrochloride', 'Amitriptyline'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'Non inferiority, multicentric, double blind study whose the primary objective is to compare the effectiveness of two products in pain reduction. Primary endpoint: reduction in pain average at day 7 compared to day 1(baseline), using Analogue Visual Scale (AVS) for pain evaluation. Secondary endpoint: to evaluate the products safety at the gastrointestinal system.', 'detailedDescription': 'Phase IIIb, non-inferiority, multicentric, double-blind study.Population: 160 patients, 80 in each study arm, both gender with mild to moderate lumbago, without irradiation and with muscle contraction, aged 18 (eighteen) and 65 (sixty five) years, without previous history of stomach or duodenal ulcer and gastritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed of the nature of the study and given written informed consent\n* Patients with mild to moderate lumbago\n* Aged between 18 and 65 years old\n\nExclusion Criteria:\n\n* Known allergy or sensitivity to drug components\n* Treatment with another anti inflammatory or corticoid\n* Treatment with oral anticoagulants\n* Treatment with oxidase monoamine 2 weeks before the study\n* Treatment with methotrexate\n* Stomach or duodenal ulcer and gastritis\n* Dehydration\n* Acute myocardial infarction or heart failure\n* Hyperthyroidism\n* Pregnant or lactating patients\n* Treatment with lithium\n* User of alcohol and barbiturates\n* Hepatic or renal failure'}, 'identificationModule': {'nctId': 'NCT01421433', 'briefTitle': 'A Comparative Study Between Lysine Clonixinate+Cyclobenzaprine and Caffeine+Carisoprodol+Sodium Diclofenac+Paracetamol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Farmoquimica S.A.'}, 'officialTitle': 'Non Inferiority,Phase III,Multicentric,Double Blind,Randomized,Parallel Study,Comparing Dolamin Flex (Lysine Clonixinate+Cyclobenzaprine) and Tandrilax(Caffeine +Carisoprodol+Diclofenac+Paracetamol)in Pain Reduction in Patients With Lumbago', 'orgStudyIdInfo': {'id': 'FQM 01/11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tandrilax', 'description': 'Reference product Intervention: Drug: Tandrilax (caffeine+carisoprodol+sodium diclofenac+paracetamol)', 'interventionNames': ['Drug: Tandrilax']}, {'type': 'EXPERIMENTAL', 'label': 'Dolamin Flex', 'description': 'Test product Intervention: Drug: Dolamin Flex (Lysine clonixinate and cyclobenzaprine)', 'interventionNames': ['Drug: Dolamin Flex']}], 'interventions': [{'name': 'Tandrilax', 'type': 'DRUG', 'description': 'Tandrilax (caffeine, carisoprodol, sodium diclofenac, paracetamol). Tablets, administered 3 times a day, for 7 consecutive days.', 'armGroupLabels': ['Tandrilax']}, {'name': 'Dolamin Flex', 'type': 'DRUG', 'description': 'Dolamin Flex (lysine clonixinate and cyclobenzaprine). Tablets, administered 3 times a day, for 7 consecutive days.', 'armGroupLabels': ['Dolamin Flex']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05673-050', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'contacts': [{'name': 'Rogerio T. Silva', 'role': 'CONTACT', 'email': 'rogerio@neo.org.br', 'phone': '551181716767'}], 'facility': 'Hospital São Luiz', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Rogerio T. Silva, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital São Luiz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Farmoquimica S.A.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pharmagenix Projetos em Medicina Farmacêutica Ltda.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}