Back to resultsComparative Clinical Trial of Lornoxicam to Diclofenac in Patients of Osteoarthritis of Knee Joint.
Primary Purpose
Osteoarthritis of Knee Joint
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Diclofenac
Lornoxicam
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of Knee Joint
Eligibility 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
Sites / Locations
- Sir Takthasinhji General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Diclofenac
Lornoxicam
Arm Description
Tab.Diclofenac 50 mg ,Orally, 12 hrly in morning and in evening after taking food for 3 months.
Tab. Lornoxicam 4 mg , orally, 8 hourly after taking food in morning , in noon and evening for 3 months.
Outcomes
Primary Outcome Measures
Difference in reduction in reading of Wong Baker face pain scale and in time of 100 meters walking test
Secondary Outcome Measures
To monitor side effects of study drugs.
Full Information
NCT ID
NCT01055470
First Posted
January 22, 2010
Last Updated
January 22, 2010
Sponsor
Government Medical College, Bhavnagar
1. Study Identification
Unique Protocol Identification Number
NCT01055470
Brief Title
Comparative Clinical Trial of Lornoxicam to Diclofenac in Patients of Osteoarthritis of Knee Joint.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Government Medical College, Bhavnagar
4. Oversight
5. Study Description
Brief Summary
The purpose of this study was to compare the pain relieving action of the lornoxicam and diclofenac in patients of OA knee.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of Knee Joint
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diclofenac
Arm Type
Active Comparator
Arm Description
Tab.Diclofenac 50 mg ,Orally, 12 hrly in morning and in evening after taking food for 3 months.
Arm Title
Lornoxicam
Arm Type
Experimental
Arm Description
Tab. Lornoxicam 4 mg , orally, 8 hourly after taking food in morning , in noon and evening for 3 months.
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Intervention Description
Tab. Diclofenac 50 mg 12 hrly, orally, in morning and in evening after taking food for 3 months.
Intervention Type
Drug
Intervention Name(s)
Lornoxicam
Intervention Description
Tab. Lornoxicam 4 mg , orally, 8 hourly after taking food in morning , in noon and evening for 3 months.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To monitor side effects of study drugs.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr.Vishalkumar Kishorbhai Vadgama, M.B;B.S.
Organizational Affiliation
Department of Pharmacology, Government Medical College, Bhavnagar-364001, Gujarat, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr. Chandrabhanu Rajkishore Tripathi, M.D. (Pharmacology)
Organizational Affiliation
Proffessor and Head, Department of Pharmacology, Government Medical College, Bhavnagar-364001, Gujarat, India
Official's Role
Study Chair
Facility Information:
Facility Name
Sir Takthasinhji General Hospital
City
Bhavnagar
State/Province
Gujarat
ZIP/Postal Code
364001
Country
India
12. IPD Sharing Statement
Learn more about this trial
Comparative Clinical Trial of Lornoxicam to Diclofenac in Patients of Osteoarthritis of Knee Joint.
We'll reach out to this number within 24 hrs