Acute Musculoskeletal Spasm Due to Low Back Pain Clinical Trial
Official title:
Evaluation of Efficacy and Tolerability of a Fixed Dose Combination of Eperisone Hydrochloride and Diclofenac Sodium in the Treatment of Acute Musculoskeletal Spasm Associated With Low Back Pain: An Observer Blind, Prospective, Randomized, Controlled Study
| Verified date | January 2013 |
| Source | Eisai Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | India: Drugs Controller General of India |
| Study type | Interventional |
The purpose of this study is to investigate the effects of a fixed dose combination of diclofenac and eperisone hydrochloride compared with plain eperisone hydrochloride in patients with low back pain.
| Status | Completed |
| Enrollment | 239 |
| Est. completion date | September 2011 |
| Est. primary completion date | June 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
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. Spondylosis deformans 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: - Patients associated with other lumbar spinal tract conditions such as spondylitis, fracture, cancers, severe arthritis and osteoporosis. - Muscular diseases such as myositis, poliomyelitis, 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, serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (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 history of 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 history of 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 acetylsalicylic 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| India | Deore Hospital | Aurangabad | Maharashtra |
| India | Department of Orthopedics, Government Medical College | Aurangabad | Maharashtra |
| India | Department of Orthopedics, Grant Medical College and Sir J.J. Group of Hospitals | Mumbai | Maharashtra |
| India | Kabre Orthopedic, Spine & Dental Care | Pune | Maharashtra |
| Lead Sponsor | Collaborator |
|---|---|
| Eisai Co., Ltd. |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Finger to Floor Distance: Improvement in Finger to Floor Distance compared to baseline. | Improvement in the Fingertip-to-Floor-surface Distance [FFD] from baseline on Day 3, Day 7 & Day 10. Finger Floor Distance [FFD] is an index for the mobility of the lumbar spinal cord and is measured as the distance between the finger-tip of the middle Finger to the Floor-surface as determined while standing with the spinal cord flexed with complete extension of knee joint. It is measured in millimeters. | Day 1,3,7 and 10 of study period | No |
| Secondary | Objective Efficacy Assessment: Improvement in Lasegue's sign compared to baseline | Lasegue's sign is the lumbar pain [or exacerbation of existing pain] experienced by the patient on passive movement of the legs during flexion of hip joint i.e. passive straight leg raising. It is assessed as either 'Positive' or 'Negative' sign. | Day 1, 3, 7 and 10 of study period | No |
| Secondary | Subjective Efficacy Assessment: Improvement of lumbar cinesalgia compared to baseline | Improvement in Lumbar Cinesalgia (pain in lumbar region) assessed on a 0 to 100mm Visual Analogue Scale (VAS) with '0' representing 'NO PAIN' and 100 representing 'SEVERE INTOLERABLE PAIN' | Day 1, 3, 7 and 10 of study period | No |