- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01300312
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
January 4, 2013 updated by: Eisai Co., Ltd.
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
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.
Study Overview
Status
Completed
Intervention / Treatment
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
Enrollment (Actual)
239
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maharashtra
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Aurangabad, Maharashtra, India, 431001
- Department of Orthopedics, Government Medical College
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Aurangabad, Maharashtra, India
- Deore Hospital
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Mumbai, Maharashtra, India, 400008
- Department of Orthopedics, Grant Medical College and Sir J.J. Group of Hospitals
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Pune, Maharashtra, India, 411009
- Kabre Orthopedic, Spine & Dental Care
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- Spondylosis deformans
- Prolapsed Intervertebral Disc (PID)
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
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
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Active Comparator: 2
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eperisone hydrochloride 50 mg as tablet formulation to be given 3 times daily after meals for 7 to 10 days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 1,3,7 and 10 of study period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 1, 3, 7 and 10 of study period
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Subjective Efficacy Assessment: Improvement of lumbar cinesalgia compared to baseline
Time Frame: Day 1, 3, 7 and 10 of study period
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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'
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Day 1, 3, 7 and 10 of study period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Suyog Mehta, General Manager - Medical and Regulatory Affairs, Eisai Pharmaceuticals India Private Limited
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
February 14, 2011
First Submitted That Met QC Criteria
February 18, 2011
First Posted (Estimate)
February 21, 2011
Study Record Updates
Last Update Posted (Estimate)
January 8, 2013
Last Update Submitted That Met QC Criteria
January 4, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Neuromuscular Manifestations
- Back Pain
- Low Back Pain
- Spasm
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Neuromuscular Agents
- Muscle Relaxants, Central
- Diclofenac
- Eperisone
Other Study ID Numbers
- EIL/EPD/CT/01/2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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