Trial design and participants
dyspepsia, hepatic or renal failure, allergy, hemophilia, pain, peripheral arterial or cerebrovascular disease, bruising, asthma, allergic disorders, LBP
SYSTEMIC DISEASE, DEFICIENCY OF COAGULATION FACTORS, THROMBOPENIA, INFLAMMATORY BOWEL DISEASE, ISCHEMIC HEART DISEASE, GASTROINTESTINAL BLEEDING, ALLERGY, RECRUITMENT, HEMOPHILIA, SPINAL CORD COMPRESSION, METASTATIC CANCER, INFECTION, CONGESTIVE HEART FAILURE, ASTHMA, ALLERGIC DISORDERS, ULCERATION, ARTERIAL HYPERTENSION
This prospective, randomized, single-blind, two-parallel-group trial was conducted in nine hospitals and clinics in central Greece following approval by the National Ethics Committee and the National Organization for Medicines (EudraCT No: 2017–004530-29). All participants provided informed consent at recruitment, which was performed in accordance with the ethical standards of the Declaration of Helsinki. The participants were blinded to the treatment they received.Adult patients were enrolled in the current trial if they presented with acute, moderate to severe LBP, defined as ≥ 40 mm on the visual analogue scale (VAS) range of 0–100 mm, ≤ 7 days prior to screening. Patients with the following characteristics were excluded from the trial: 1) back pain due to metastatic cancer spinal infection or spinal cord compression, 2) treatment with a NSAID or skeletal muscle relaxant within the last 24 h prior to trial entry, 3) history of inflammatory bowel disease, 4) history of peptic ulceration, gastrointestinal bleeding, or severe dyspepsia, 5) history of concurrent systemic disease, 6) history of thrombopenia, easy bruising, hemophilia, or deficiency of coagulation factors, 7) history of hepatic or renal failure, 8) history of established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial or cerebrovascular disease, 9) known allergy to NSAIDs and skeletal muscle relaxants, 10) poorly controlled arterial hypertension, 11) asthma or other allergic disorders induced by acetylsalicylic acid or NSAIDs, 12) concurrent administration of angiotensin converting enzyme inhibitors for arterial hypertension, antiplatelet agents, or anticoagulants, 13) pregnant, breast-feeding, under a highly effective contraceptive method of birth control, 14) current participation or prior participation within the last 30 days prior to trial entry in another investigational device or drug trial, patients, 15) inability or unwillingness to comply with the trial procedures, and 16) legally incapacitated or legally institute-detained patients.Sample size calculation was performed with the StudySize software (version 2.0.5, CreoStat HB, 2012). The required sample size to observe a difference of 10% in mean change in VAS from baseline to 3 h after administration between Test and Reference products which is considered as clinically significant [