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

January 22, 2010 updated by: Government Medical College, Bhavnagar

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Gujarat
      • Bhavnagar, Gujarat, India, 364001
        • Sir Takthasinhji General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in reduction in reading of Wong Baker face pain scale and in time of 100 meters walking test
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To monitor side effects of study drugs.
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

January 22, 2010

First Submitted That Met QC Criteria

January 22, 2010

First Posted (Estimate)

January 25, 2010

Study Record Updates

Last Update Posted (Estimate)

January 25, 2010

Last Update Submitted That Met QC Criteria

January 22, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pharmacol no.02 /2008 Research

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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