Controlled Labeled, Randomized Prospective, Multicentric Parallel Group, Phase-III Clinical Trial to Compare Efficacy and Safety for FDC of Eperisone150mg SR and Diclofenac 100mg SR capsule OD with Eperisone 50 mg EC Tablet T.I.D in Subjects suffering with Acute Musculoskeletal Spasm Associated With Low Backache.

Phase 3

Completed

• Conditions: Patients Suffering with Acute Musculoskeletal Spasm Associated with Low Backache

• Registration Number: CTRI/2010/091/001154
• 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 (Day -1). Screening will include complete clinical evaluation (medical history, physical examination, record of height, weight and vital signs).Enrolled subjects shall receive the medication for 1weeks, Day1(Visit 2). At visit3 (Day4) efficacy and ADR evaluation will be done and VAS score from subject diary would be evaluated and recorded in the case report form. At visit 4(Day 7) i.e. end of protocol therapy, efficacy, safety, tolerability and ADR monitoring will be done. 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: 2013-03-20

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

• Ages Eligible for Study: 18 Years to 70 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No 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 & spasm associated with fractured bone.
• Patients who had taken any form of skeletal muscle relaxant in the previous 7 days.
• Patients with hypersensitivity to any of the ingredients of the study drug formulations.
• Pregnant or Lactating women or 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 or trauma, severe metabolic, endocrine or electrolyte disturbances and seizures in preceding 8 weeks.
• Patients having any of the following disorders: Renal failure, Bulimia, Hypo and Hyperthyroidism Nephrotic syndrome.
• Patients having uncontrolled diabetes mellitus, or any other metabolic or endocrine disorder.
• Patients that have received treatment with any investigational drug in the preceding 4 weeks.
• Patients likely to be non-compliant.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison percent of reduction in pain within the last 24 hours assessed using VAS at Day 4 in both treatment groups	Day 4

Secondary Outcome Measures

Name	Time	Method
Average reduction pain within the last 24 hours assessed using VAS by Investigator and Subject at day 7 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