A Clinical trial of Fixed Dose Combination of Lornoxicam 16mg SR + Thiocolchicoside 16mg SR Tablet OD Compared with Thiocolchicoside 8mg Capsule BID in Patients Suffering pain associated with Skeletal Muscular Spasm of any etiology.

Phase 3

Recruiting

• Conditions: Pain associated with Skeletal Muscular Spasm of any Etiology

• Registration Number: CTRI/2012/02/002440
• Lead Sponsor: Inventia Healthcare 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 (day 4) efficacy, ADR evaluation and drug dispensing for next visit will be done. At visit 4 (day 7) end of 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: 2012-02-20
• Last Update Posted: 2012-05-21

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Non specific skeletal muscular spasm, with an acute episode.
• Recent onset (<48 hours) defined by average pain and local immobility within the last 24 hours equal or more than grade 4 on the Visual Analogue Scale (VAS) Willing to give written informed consent.

Exclusion Criteria

• Acute pain due to vertebral collapse or of no mechanical origin (suspected by history taking and physical examination), such as neoplasm, infection or inflammatory disorders.
• Low back pain of diagnosis category 3 (low back pain radiating beyond the knee, with no neurologic signs) or 4 (low back pain radiating to a precise and entire leg dermatome, with or without neurologic signs), as defined by the International Paris Task Force on Back Pain ( Annexure –V) History of inflammatory arthritis of large joints.
• History of seizure disorders.
• History of malignant tumor.
• Treatment with steroidal agents (including aspirin) during the two days prior to prospective inclusion, prolonged used of corticosteroids.
• Treatment with NSAIDs or muscle relaxant or opioid analgesics within 3 days of admission, Psychiatric or mental diseases.
• Immune Compromised HIV.
• Inclusion in another study in the past six months or previous inclusion in this study, History of alcohol, drugs or narcotics abuse.
• Recent history of violent trauma.
• Constant progressive, non mechanical pain (no relief with bed rest).
• Thoracic pain.
• Patient systemically unwell.
• Unexplained weight loss.
• Structural deformity.
• Clinical significant renal dysfunction defined by Creatinine > 1.5 mg/dl Clinically significant hepatic dysfunction defined by: Total Bilirubin > 2 mg/dl SGOT (AST) > 1.5 IU/L SGPT (ALT) > 1.5 IU/L Patients who have received other therapy (physiotherapy, physical manipulations, invasive intervention, acupuncture therapy.) within the last 48 hours.
• Pregnancy, breast feeding or women of childbearing potential not using efficient contraception.
• Known or suspected hypersensitivity to Thiocolchicoside and Lornoxicam.

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.	At day 4 of the treatment

Secondary Outcome Measures

Name	Time	Method
Average reduction in mean pain score within last 24 hours assessed using VAS by Investigator and Subject at day 7 i.e. completion of protocol treatment in both treatment groups.	At day 7 of the treatment

Trial Locations

Locations (4)

District Hospital; 🇮🇳 JAMMU, & KASHMIR, India

Dr. Nehras Orthopaedics and Trauma Centre; 🇮🇳 Meerut, UTTAR PRADESH, India

Hope Hospital; 🇮🇳 Meerut, UTTAR PRADESH, India

NARENDRA PRAKASH HEALTHCARE CENTER; 🇮🇳 Delhi, DELHI, India

District Hospital

🇮🇳JAMMU, & KASHMIR, India

Dr Tarsem Motten

Principal investigator

09419101542

drtarsemmoten@yahoo.in