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.

Phase 3

Completed

• Conditions: 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

The study will be conducted after obtaining written informed consent from the subjects. The subjects will undergo medical screening during pre-study visit (Visit 1). Screening will include complete clinical evaluation (medical history, physical examination, record of height, weight and vital signs). Female volunteers of child bearing capability will be subjected to a urine pregnancy test. Enrolled subjects will receive the medication for 4 days (Visit 2). At visit 3 efficacy and ADR evaluation will be done and medication for another 3 days dispensed. At visit 4 end of therapy efficacy, safety, tolerability and ADR monitoring will be done. The reduction inintensity of pain would be assessed by VAS and the safety evaluation would be done by analyzing the lab parameters (LFT and RFT). Subjects are allowed to visit to investigator at any time point during the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-24
• Last Update Posted: 2013-03-21

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.	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.	Day 7

Trial Locations

Locations (6)

Hope Hospital; 🇮🇳 Meerut, UTTAR PRADESH, India

Narendra prakash healthcare clinical; 🇮🇳 Delhi, DELHI, India

REGE Clinic, B-1, 56/57/58, SUBHASH NAGAR; 🇮🇳 Mumbai, MAHARASHTRA, India

REGISTRAR DEPARTMENT OF ORTHOPEDIC; 🇮🇳 JAMMU, & KASHMIR, India

SIROHI CLINIC; 🇮🇳 Meerut, UTTAR PRADESH, India

SOMDATT POLY CLINIC,; 🇮🇳 Delhi, DELHI, India

Hope Hospital

🇮🇳Meerut, UTTAR PRADESH, India

Dr Rahul Nehra

Principal investigator

09837052678

rahulnehra2001@yahoo.co.in