Back to resultsA 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
Primary Purpose
Acute Musculoskeletal Spasm Due to Low Back Pain
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Eperisone hydrochloride and Diclofenac sodium
Eperisone hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Acute Musculoskeletal Spasm Due to Low Back Pain focused on measuring eperisone, diclofenac, low back pain
Eligibility 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:
- 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.
Sites / Locations
- Department of Orthopedics, Government Medical College
- Deore Hospital
- Department of Orthopedics, Grant Medical College and Sir J.J. Group of Hospitals
- Kabre Orthopedic, Spine & Dental Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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'
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01300312
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Musculoskeletal Spasm Due to Low Back Pain
Keywords
eperisone, diclofenac, low back pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
239 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Eperisone hydrochloride and Diclofenac sodium
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Eperisone hydrochloride
Intervention Description
eperisone hydrochloride 50 mg as tablet formulation to be given 3 times daily after meals for 7 to 10 days
Primary Outcome Measure Information:
Title
Finger to Floor Distance: Improvement in Finger to Floor Distance compared to baseline.
Description
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.
Time Frame
Day 1,3,7 and 10 of study period
Secondary Outcome Measure Information:
Title
Objective Efficacy Assessment: Improvement in Lasegue's sign compared to baseline
Description
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.
Time Frame
Day 1, 3, 7 and 10 of study period
Title
Subjective Efficacy Assessment: Improvement of lumbar cinesalgia compared to baseline
Description
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'
Time Frame
Day 1, 3, 7 and 10 of study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suyog Mehta
Organizational Affiliation
General Manager - Medical and Regulatory Affairs, Eisai Pharmaceuticals India Private Limited
Official's Role
Study Director
Facility Information:
Facility Name
Department of Orthopedics, Government Medical College
City
Aurangabad
State/Province
Maharashtra
ZIP/Postal Code
431001
Country
India
Facility Name
Deore Hospital
City
Aurangabad
State/Province
Maharashtra
Country
India
Facility Name
Department of Orthopedics, Grant Medical College and Sir J.J. Group of Hospitals
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400008
Country
India
Facility Name
Kabre Orthopedic, Spine & Dental Care
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411009
Country
India
12. IPD Sharing Statement
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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
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