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

This study has been completed.
Sponsor:
Information provided by:
Government Medical College, Bhavnagar
ClinicalTrials.gov Identifier:
NCT01055470
First received: January 22, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To monitor side effects of study drugs. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 22, 2010
Last Updated: January 22, 2010
Health Authority: India: Institutional Review Board

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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013