Lornoxicam + Eperisone Tablets in the treatment of Cervical Spondylosis.

Phase 3

• Conditions: Cervical Spondylosis

• Registration Number: CTRI/2009/091/000794
• Lead Sponsor: Hetero Labs Limited

Brief Summary

1.This is a Comparative, Randomized, Open Label, Parallel, Multicentric Study for Efficacy and Safety of Lornoxicam+ Eperisone versus Lornoxicam in Management of Cervical Spondylosis. 2. The proposed number of subject to be enrolled in to the study is 300 (this number includes the expected no. of dropouts) and data will be submitted 240 completed patients. Study population will comprise of Patients with Cervical Spondylosis.3.The recommended dose of Lornoxicam in dose of 4mg + Eperisone in dose of 50mg in comparison with Lornoxicam in the dose of 4mg thrice daily for 2 weeks. 4.The primary efficacy outcome will be change in pain, neck stiffness and range of neck movement from baseline to end of the study and the secondary efficacy outcome is to evaluate of the safety by assessing the laboratory parameters, treatment emergent adverse events, and overall response of the patient & investigator at the end of the study.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 230

Inclusion Criteria

• a) Male or female patientsb) Between 20-65 years of agec) Willing to give written informed consent and willing to comply with trial protocol.
• d) Out patients with diagnosis of cervical spondylosis.
• e) Patients with at least 40 mm pain rating on VAS scale.
• f) Patient and / or physician?s global assessment of arthritic condition as fair, poor or very poor.
• g) Patients not on any anti-inflammatory or other therapy in the past 2 weeks known to affect the study outcome.

Exclusion Criteria

a) Pregnant and lactating womenb) Patients with H/O any drug allergy c) Unwilling to comply with the protocol requirementsd) Patients with gastro-intestinal disease, peptic ulcer, bleeding disorder and fecal blood loss.e) Patients with cardiac, hepatic, renal dysfunction and haemopoetic disorderf) Patients with hypertensiong) Patients deemed ineligible by the investigator.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy outcome will be change in pain, neck stiffness and range of neck movement from baseline to end of the study (0-14days)	0,3,7 & 14 days

Secondary Outcome Measures

Name	Time	Method
The Secondary outcome is to evaluate safety by assessing the laboratory parameters, treatment emergent adverse events, and overall response of the patient & investigator at the end of the study	0,3,7 & 14 days

Trial Locations

Locations (13)

Aakarsh Orthopedic Hospital; 🇮🇳 Nellore, ANDHRA PRADESH, India

Abhishek Hospital; 🇮🇳 Vadodara, GUJARAT, India

Dept of Clinical Pharmacology and Therapeutics; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

G.V.N Hospital; 🇮🇳 46,, Singarathope,, India

Hyma Hospitals; 🇮🇳 Guntur, ANDHRA PRADESH, India

Kavya Ortho Center; 🇮🇳 Coimbatore, TAMIL NADU, India

King George Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

S. V. R. R. Govt. Gen. Hospital; 🇮🇳 India

S.V. Nirtar Olatpur Hospital; 🇮🇳 Cuttack, ORISSA, India

Sanjoe Hospital; 🇮🇳 Ernakulam, Dt,-, India

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Aakarsh Orthopedic Hospital

🇮🇳Nellore, ANDHRA PRADESH, India

Dr.D.Narayana Reddy

Principal investigator

aakarsh_heman@yahoo.co.in