Control- Labeled, Prospective, Randomized, Parallel group, Multicentric, Phase III Clinical Trial to Evaluate Efficacy and Safety of Eperisone HCl SR 150mg OD Capsule compared with Eperisone HCl 50mg Tablet T.I.D in patients suffering from Acute Musculoskeletal Spasm associated with Low Back Pain.
- Conditions
- Health Condition 1: null- Patient Suffering form Acute Musculoskeletal Spasm associated with Low Back Pain
- Registration Number
- CTRI/2010/091/001138
- Lead Sponsor
- Inventia Health Care Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Patients of either sex between 18 to 70 years of age.
Patients with confirmed diagnosis of Acute Musculoskeletal spasm with Low Back Pain due to:
Spondylosis deformans.
Prolapsed Intervertebral Disc (PID).
Muscle sprains with spasms.
Patients who are willing to take the medications as directed and willing to come for follow-ups.
Patients who are willing to comply with the protocol requirements.
Patients who are willing to give the written informed consent.
Patients with other associated spasm conditions like traumatic pain with spasms, cervical spondylitis and pain and spasm associated with fractured bone.
Patients who had taken any form of skeletal muscle relaxant in the previous seven days
Patients with hypersensitivity to any of the ingredients of the study drug formulations.
Women of child bearing potential not following adequate contraceptive measures
Patients unwilling or unable to comply with the study procedures
Patients having a history of severe acute infection, major surgery, trauma, severe metabolic, endocrine or electrolyte disturbances and seizures in preceding eight weeks
Patients having severe hepatic insufficiency defined by an SGOT or SGPT value equal or higher than the three fold normal values of the respective laboratory reference value
Patients having any of the following disorders: Renal failure, Bulimia, Hypo and Hyperthyroidism, Nephrotic syndrome, Anorexia nervosa, biliary obstruction and severe cardiac dysfunction.
Patients having uncontrolled diabetes mellitus, or any other metabolic or endocrine disorder
Patients that have received treatment with any investigational drug in the preceding four weeks
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison percent of pain reduction within last 24 hours assessed using VAS at Day 4 in both treatment groups.Timepoint: day 4
- Secondary Outcome Measures
Name Time Method Average reduction in mean pain score within last 24 hours assessed using VAS by Investigator and Subject at Day7 i.e. completion of protocol treatment in both treatment groups.Timepoint: Day 7