A Comparative,Randomized Parallel group,Multicentric Prospective Phase III Clinical trial of FDC of Tolperisone Hcl SR 450mg+ Diclofenac sodium SR100mg tablet OD compared with Tolperisone Hcl 150mg tablet TID for 7 Days in Patients Suffering with Acute Non Specific Low Back Pain.

Phase 3

Completed

• Conditions: Acute Non Specific Low Back Pain

• Registration Number: CTRI/2011/10/002074
• 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. At day7 (visit 4) 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: 2011-10-20
• Last Update Posted: 2012-01-27

Recruitment & Eligibility

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

Inclusion Criteria

Non specific low back pain with an acute episode of recent onset (48 hours) defined by average pain within the last 24 hours equal or more than grade 4 on the Visual Analogue Scale (VAS) Low back pain of diagnosis category 1 (low back pain radiating no farther than the intergluteal fold) or 2 (low back pain radiating no farther than the knee), as defined by the International Paris Task Force on Back Pain Willing to give written informed consent.

Exclusion Criteria

• Low back pain due to vertebral collapse or of no mechanical origin (suspected by history taking and physical examination), such as neoplasm, infection or inflammatory disorder., 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.
• 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 1.5µmol/L.
• Clinically significant hepatic dysfunction defined by: Total Bilirubin 2 µmol/L.
• SGOT (AST) 1.5 U/L.
• SGPT (ALT) 1.5 U/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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To demonstrate the superiority of the SR of fixed - combination of a muscle relaxant, Tolperisone Hcl 450mg and non steroidal anti-inflammatory drug, Diclofenac sodium 100mg, over oral Tolperisone Hcl 150mg tablet as single drug therapy, on average pain and mobility within the last 24 hours in adults suffering from acute non specific low back pain with an episode of recent onset.	DAY -1DAY 1DAY 4DAY 7

Secondary Outcome Measures

Name	Time	Method
To compare the safety of the oral FDC of Tolperisone Hcl + Diclofenac Sodium, to that of Tolperisone Hcl.	DAY -1DAY 1DAY 4DAY 7

Trial Locations

Locations (7)

Govt. Medical College & Hospital; 🇮🇳 JAMMU, & KASHMIR, India

Hope Hospital; 🇮🇳 Meerut, UTTAR PRADESH, India

Jeevandeep Hospital; 🇮🇳 Amravati, MAHARASHTRA, India

MANGLORE HEART CENTER; 🇮🇳 Bangalore, KARNATAKA, India

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

SHRIKRUPA FRACTURE & ACCIDENTAL HOSPITAL; 🇮🇳 Akola, MAHARASHTRA, India

Sirohi Clinic; 🇮🇳 Meerut, UTTAR PRADESH, India

Govt. Medical College & Hospital

🇮🇳JAMMU, & KASHMIR, India

Dr Tarsem Motten

Principal investigator

09419101542

drtarsemmoten@yahoo.in