Comparative Clinical Trial of Lornoxicam to Diclofenac in Patients of Osteoarthritis of Knee Joint.
Open, Randomized, Controlled Clinical Trial of Lornoxicam as Compared to Diclofenac in Osteoarthritis of Knee Joint in Patients of Tertiary Care Hospital of Gujarat.
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study was to compare the pain relieving action of the lornoxicam and diclofenac in patients of OA knee.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 22, 2010
CompletedFirst Posted
Study publicly available on registry
January 25, 2010
CompletedJanuary 25, 2010
January 1, 2010
6 months
January 22, 2010
January 22, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Difference in reduction in reading of Wong Baker face pain scale and in time of 100 meters walking test
3 months
Secondary Outcomes (1)
To monitor side effects of study drugs.
3 months
Study Arms (2)
Diclofenac
ACTIVE COMPARATORTab.Diclofenac 50 mg ,Orally, 12 hrly in morning and in evening after taking food for 3 months.
Lornoxicam
EXPERIMENTALTab. Lornoxicam 4 mg , orally, 8 hourly after taking food in morning , in noon and evening for 3 months.
Interventions
Tab. Diclofenac 50 mg 12 hrly, orally, 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sir Takthasinhji General Hospital
Bhavnagar, Gujarat, 364001, India
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 22, 2010
First Posted
January 25, 2010
Study Start
December 1, 2008
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
January 25, 2010
Record last verified: 2010-01