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 Pain

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Co., Ltd.
• Treatments: Diclofenac; Eperisone

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. 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.