A clinical Trial to study the effects of a fixed dose combination of diclofenac and eperisone hydrochloride with plain eperisone hydrochloride in patients with low back pai
- Registration Number
- CTRI/2010/091/002934
- Lead Sponsor
- Eisai Pharmaceuticals India Private Limited, 1st Floor, B-Wing, Marwah Centre, Krishanlal Marwah Marg, Andheri East, Mumbai - 400072
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 240
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
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in Finger-to-Floor distance compared to baselineTimepoint: day 0, day 3, day 7 and day 10 of study visit
- Secondary Outcome Measures
Name Time Method