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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|ClinicalTrials.gov Identifier: NCT01300312|
Recruitment Status : Completed
First Posted : February 21, 2011
Last Update Posted : January 8, 2013
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||239 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- 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.
- 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.
- 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'
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 ClinicalTrials.gov identifier (NCT number): NCT01300312
|Department of Orthopedics, Government Medical College|
|Aurangabad, Maharashtra, India, 431001|
|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|
|Study Director:||Suyog Mehta||General Manager - Medical and Regulatory Affairs, Eisai Pharmaceuticals India Private Limited|