Osteoarthritis of Knee JointNCT01055470
Comparative Clinical Trial of Lornoxicam to Diclofenac in Patients of Osteoarthritis of Knee Joint.
A study testing Diclofenac and Lornoxicam in people with Osteoarthritis of Knee Joint, run by Government Medical College, Bhavnagar at 1 site in India.
Trial summary
The purpose of this study was to compare the pain relieving action of the lornoxicam and diclofenac in patients of OA knee. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Osteoarthritis of Knee Joint
- What is being tested?
- Diclofenac and Lornoxicam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2008to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
The purpose of this study was to compare the pain relieving action of the lornoxicam and diclofenac in patients of OA knee.
- Conditions
- Osteoarthritis of Knee Joint
- Being tested
- Diclofenac, Lornoxicam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiclofenacDrug
Tab. Diclofenac 50 mg 12 hrly, orally, in morning and in evening after taking food for 3 months.
LornoxicamDrug
Tab. Lornoxicam 4 mg , orally, 8 hourly after taking food in morning , in noon and evening for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac | Active comparator | Tab.Diclofenac 50 mg ,Orally, 12 hrly in morning and in evening after taking food for 3 months. Receives: Drug: Diclofenac |
| Lornoxicam | Experimental | Tab. Lornoxicam 4 mg , orally, 8 hourly after taking food in morning , in noon and evening for 3 months. Receives: Drug: Lornoxicam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in reduction in reading of Wong Baker face pain scale and in time of 100 meters walking test
Measured: 3 months
Secondary outcomes (1)
To monitor side effects of study drugs.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2010 (estimated)
- Study startDec 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of Knee JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government Medical College, Bhavnagar
- Sponsor type
- University, hospital or other
- Investigators
- Dr.Vishalkumar Kishorbhai Vadgama, M.B;B.S., Principal investigator, Department of Pharmacology, Government Medical College, Bhavnagar-364001, Gujarat, IndiaDr. Chandrabhanu Rajkishore Tripathi, M.D. (Pharmacology), Study chair, Proffessor and Head, Department of Pharmacology, Government Medical College, Bhavnagar-364001, Gujarat, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055470
- Sponsor's protocol ID
- Pharmacol no.02 /2008 Research
- Status last verified
- Jan 2010
- First submitted
- 22 Jan 2010
- Last updated
- 25 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01055470
- Acronym / sponsor ID
- Pharmacol no.02 /2008 Research
- Conditions
- Osteoarthritis of Knee Joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Government Medical College, BhavnagarUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 25 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to compare the pain relieving action of the lornoxicam and diclofenac in patients of OA knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diclofenac | Active comparator | Drug: DiclofenacTab.Diclofenac 50 mg ,Orally, 12 hrly in morning and in evening after taking food for 3 months. |
| Lornoxicam | Experimental | Drug: LornoxicamTab. Lornoxicam 4 mg , orally, 8 hourly after taking food in morning , in noon and evening for 3 months. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiclofenacTab. Diclofenac 50 mg 12 hrly, orally, in morning and in evening after taking food for 3 months. | Drug | Diclofenac |
| LornoxicamTab. Lornoxicam 4 mg , orally, 8 hourly after taking food in morning , in noon and evening for 3 months. | Drug | Lornoxicam |
Primary outcome
Difference in reduction in reading of Wong Baker face pain scale and in time of 100 meters walking test
Time frame: 3 months
1 secondary outcome
To monitor side effects of study drugs.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2010.
Related trials for Osteoarthritis of Knee Joint
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr.Vishalkumar Kishorbhai Vadgama, M.B;B.S. principal investigator
Department of Pharmacology, Government Medical College, Bhavnagar-364001, Gujarat, India
Dr. Chandrabhanu Rajkishore Tripathi, M.D. (Pharmacology) study chair
Proffessor and Head, Department of Pharmacology, Government Medical College, Bhavnagar-364001, Gujarat, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diclofenac and Lornoxicam in people with Osteoarthritis of Knee Joint, run by Government Medical College, Bhavnagar at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in reduction in reading of Wong Baker face pain scale and in time of 100 meters walking test (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2010.