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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01300312
Recruitment Status : Completed
First Posted : February 21, 2011
Last Update Posted : January 8, 2013
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Musculoskeletal Spasm Due to Low Back Pain Drug: Eperisone hydrochloride and Diclofenac sodium Drug: Eperisone hydrochloride Phase 3

Detailed Description:
This study is an observer-blind, prospective randomized, controlled study to evaluate efficacy and safety of fixed dose combination of eperisone hydrochloride 50 mg and diclofenac sodium 50 mg three times daily with plain eperisone hydrochloride 50 mg three times daily in patients with musculoskeletal spasm associated with low back pain. A total of 240 adult patients of either sex, 120 patients in each arm, who fulfill the inclusion and exclusion criteria will be included in this study. The patients will be evaluated at Days 3, 7 and 10 of the study visit for efficacy and safety. The efficacy evaluation includes objective parameters like Finger-to-Floor distance, Lasegue's sign, tenderness of par vertebral muscles, lumbar and dorsal hypermyotonia, leg tendon reflexes, need for rescue medication and subjective parameters like improvement in lumbar cinesalgia, pain in lower extremities, sensory disturbances of lower limb, and Global Assessment of Response to Therapy (PGART). Patients will be evaluated for safety on the clinical adverse events reported during the study period, sedation on drowsy alert scale and Global Assessment of Tolerability to Therapy (PGATT). The patients will also be evaluated for laboratory safety as assessed by measuring laboratory parameters for hemogram, renal and hepatic parameters.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Study Start Date : February 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Eperisone hydrochloride and Diclofenac sodium
Fixed dose capsule formulation of eperisone hydrochloride 50 mg plus diclofenac sodium 50 mg to be given 3 times a day after meals for 7 to 10 days
Active Comparator: 2 Drug: Eperisone hydrochloride
eperisone hydrochloride 50 mg as tablet formulation to be given 3 times daily after meals for 7 to 10 days

Primary Outcome Measures :
  1. Finger to Floor Distance: Improvement in Finger to Floor Distance compared to baseline. [ Time Frame: Day 1,3,7 and 10 of study period ]
    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.

Secondary Outcome Measures :
  1. Objective Efficacy Assessment: Improvement in Lasegue's sign compared to baseline [ Time Frame: Day 1, 3, 7 and 10 of study period ]
    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.

  2. Subjective Efficacy Assessment: Improvement of lumbar cinesalgia compared to baseline [ Time Frame: Day 1, 3, 7 and 10 of study period ]
    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'

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01300312

Department of Orthopedics, Government Medical College
Aurangabad, Maharashtra, India, 431001
Deore Hospital
Aurangabad, Maharashtra, India
Department of Orthopedics, Grant Medical College and Sir J.J. Group of Hospitals
Mumbai, Maharashtra, India, 400008
Kabre Orthopedic, Spine & Dental Care
Pune, Maharashtra, India, 411009
Sponsors and Collaborators
Eisai Co., Ltd.
Study Director: Suyog Mehta General Manager - Medical and Regulatory Affairs, Eisai Pharmaceuticals India Private Limited

Responsible Party: Eisai Co., Ltd. Identifier: NCT01300312     History of Changes
Other Study ID Numbers: EIL/EPD/CT/01/2010
First Posted: February 21, 2011    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: January 2013

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
low back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neuromuscular Manifestations
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Muscle Relaxants, Central
Neuromuscular Agents
Autonomic Agents
Vasodilator Agents