Comparative Clinical Trial of Lornoxicam to Diclofenac in Patients of Osteoarthritis of Knee Joint.

Osteoarthritis of Knee Joint Clinical Trial

Official title:

Open, Randomized, Controlled Clinical Trial of Lornoxicam as Compared to Diclofenac in Osteoarthritis of Knee Joint in Patients of Tertiary Care Hospital of Gujarat.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01055470
• Other study ID #: Pharmacol no.02 /2008 Research
• Status: Completed
• Phase: N/A
• First received: January 22, 2010
• Last updated: January 22, 2010
• Start date: December 2008
• Est. completion date: June 2009

Study information

• Verified date: January 2010
• Source: Government Medical College, Bhavnagar
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to compare the pain relieving action of the lornoxicam and diclofenac in patients of OA knee.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• Newly diagnosed patient aged between 25 to 65 yrs of either gender suffering from osteoarthritis of knee according to criteria given by American College of Rheumatology

• Informed consent obtained from the patient.

Exclusion Criteria:

• Patients with any other systemic llness,

• Patients with pregnancy and lactation,

• Patients taking other drugs like lithium[4], digoxin, methotrexate, anticoagulants, antidiabetics, diuretics,

• Patients with H/O hypersensitivity to NSAIDs,

• Patients who had consumed any analgesics in last 1 month

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of Knee Joint
• Osteoarthritis, Knee

Intervention

Drug:
• Diclofenac
Tab. Diclofenac 50 mg 12 hrly, orally, in morning and in evening after taking food for 3 months.
• Lornoxicam
Tab. Lornoxicam 4 mg , orally, 8 hourly after taking food in morning , in noon and evening for 3 months.

Locations

Country	Name	City	State
India	Sir Takthasinhji General Hospital	Bhavnagar	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Government Medical College, Bhavnagar

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in reduction in reading of Wong Baker face pain scale and in time of 100 meters walking test		3 months	No
Secondary	To monitor side effects of study drugs.		3 months	Yes