None listed
Conditions
Interventions
Intervention1: Fixed dose combination of Eperisone Hydrochloride 50mg with Diclofenac Sodium 50mg in a Capsule: 1 capsule three times a day for 7 to 10 days
Control Intervention1: Eperisone Hydrochlor
Sponsors
Eisai Pharmaceuticals India Private Limited, 1st Floor, B-Wing, Marwah Centre, Krishanlal Marwah Marg, Andheri East, Mumbai - 400072
Eligibility
Inclusion criteria
Inclusion criteria: - Patient of either sex between 18 to 60 years of age - Patients with confirmed diagnosis of Acute Musculoskeletal spasm with Low Back Pain due to any of the following causes: 1.Spondylosisdeformans 2.Prolapsed Intervertebral Disc (PID) 3.Muscle Sprains with spasms - Patients willing to take the medications as directed and willing to come for the follow-ups - Willing to comply with the protocol requirements - Willing to give the written informed consent
Exclusion criteria
Exclusion criteria: - Patients associated with other lumbar spinal tract conditions such as spondylitis, fracture, cancers, severe arthritis and osteoporosis. - Muscular diseases such as myositis, poliomyositis, muscular dystrophy and myotonia. - Other known systemic diseases affecting the neurological or endocrine. - Patients with moderate to severe hepatic impairment (defined as increase in serum bilirubin, SGOT & SGPT by >2.5 times the upper reference level of the laboratory values) and renal impairment (defined as increase in serum creatinine and Blood urea nitrogen by >2.5 times the upper reference level of the laboratory values). - Patients who had taken any form of skeletal muscle relaxant in the previous 7 days. - Pregnant / Lactating Woman or women of child bearing potential not following adequate contraceptive measures. - Patients with known hypersensitivity to ingredients of study/active comparators. - Patients with any previous H/O or current episode of cardio-vascular disorders. - Subject known to be having any of the following disorder: Renal failure, Bulimia, Hypo and hyperthyroidism, Nephrotic Syndrome, Anorexia nervosa, Biliary obstruction, severe cardiac dysfunction. - Uncontrolled diabetes mellitus or any other metabolic disorder. - Pediatric and Pregnant patients. - Patients with H/O alcoholic/substance abuse. - Treatment with any investigational drug in the preceding 4 weeks. - Patients with active or recent history of, inflammatory diseases of the gastrointestinal tract such as peptic ulcer, gastritis, regional enteritis, or ulcerative colitis. - Patients in whom Acetyl Salicylic Acid (ASA) or other non-steroidal anti-inflammatory agents (NSAIDs) have induced asthma, rhinitis, urticaria or other allergic manifestations. - Any other condition that, in the opinion of the investigator, does not justify the inclusion of the subject in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Finger-to-Floor distance compared to baselineTimepoint: day 0, day 3, day 7 and day 10 of study visit | — |
Secondary
| Measure | Time frame |
|---|---|
| ClinicalSafety: - Evaluation of Sedation on Drowsy Alert Scale. - Recording Adverse events, either spontaneously reported by the patient, or noticed by the physician during the trial -Global Assessment of Tolerability to Therapy [PGATT] on a 5-point scale Timepoint: Day 3, 7 & 10 of the Study Period;Compliance to therapy: - Compliance defined as consumption of >80% of the medication to be taken as per treatment schedule, will be assessed at each follow-up visit. Compliance is -Drop-out rate will be determined at the end of the trial. Timepoint: Day 3,7 & 10 of study period for complaince;Efficacy: Objective - Improvement in Lasegue's Sign, tenderness of paravertebral muscles, lumbar & dorsal hypermyotonia, leg tendon reflexes, need for rescue medication; Subjective - Improvement in lumbar cinesalgia, pain in lower extremities, sensory disturbances of lower limb, global assessment of response to therapyTimepoint: evaluation on day 0, 3, 7 & 10 of study period;Laboratory Safety: The laboratory safety would be assessed by measuring the laboratory parameters for hemogram, hepatic and renal parameters as below: - Hemogram (Hb, RBC Count, TLC, Differential Count, Platelet Count) - Blood Sugar (Random) - Hepatic Function Parameters (Bilirubin, SGPT, SGOT) - Renal Function Parameters (Sr.Creatinine, Blood Urea Nitrogen) Timepoint: Baseline and end of study visits | — |
Countries
India
Contacts
Public ContactDr. Suyog C. Mehta
General Manager - Medical & Regulatory Affairs, Eisai Pharmaceuticals India Private Limited, 1st Floor, B-Wing, Marwah Centre, Krishanlal MArwah Marg, Andheri East, Mumbai - 400072
Outcome results
None listed