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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01055470
First Posted: January 25, 2010
Last Update Posted: January 25, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Government Medical College, Bhavnagar
  Purpose
The purpose of this study was to compare the pain relieving action of the lornoxicam and diclofenac in patients of OA knee.

Condition Intervention
Osteoarthritis of Knee Joint Drug: Diclofenac Drug: Lornoxicam

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Government Medical College, Bhavnagar:

Primary Outcome Measures:
  • Difference in reduction in reading of Wong Baker face pain scale and in time of 100 meters walking test [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • To monitor side effects of study drugs. [ Time Frame: 3 months ]

Enrollment: 40
Study Start Date: December 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Diclofenac
Tab.Diclofenac 50 mg ,Orally, 12 hrly in morning and in evening after taking food for 3 months.
Drug: Diclofenac
Tab. Diclofenac 50 mg 12 hrly, orally, in morning and in evening after taking food for 3 months.
Experimental: Lornoxicam
Tab. Lornoxicam 4 mg , orally, 8 hourly after taking food in morning , in noon and evening for 3 months.
Drug: Lornoxicam
Tab. Lornoxicam 4 mg , orally, 8 hourly after taking food in morning , in noon and evening for 3 months.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01055470


Locations
India
Sir Takthasinhji General Hospital
Bhavnagar, Gujarat, India, 364001
Sponsors and Collaborators
Government Medical College, Bhavnagar
Investigators
Principal Investigator: Dr.Vishalkumar Kishorbhai Vadgama, M.B;B.S. Department of Pharmacology, Government Medical College, Bhavnagar-364001, Gujarat, India
Study Chair: Dr. Chandrabhanu Rajkishore Tripathi, M.D. (Pharmacology) Proffessor and Head, Department of Pharmacology, Government Medical College, Bhavnagar-364001, Gujarat, India
  More Information

Responsible Party: Dr. C. B. Tripathi, Professor and Head , Department of Pharmacology, Government Medical College, Bhavnagar-364001, Gujarat, India
ClinicalTrials.gov Identifier: NCT01055470     History of Changes
Other Study ID Numbers: Pharmacol no.02 /2008 Research
First Submitted: January 22, 2010
First Posted: January 25, 2010
Last Update Posted: January 25, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Diclofenac
Lornoxicam
Piroxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action