Knee OsteoarthritisPhase 4NSKONCT01860833
NSAID Treatment in Knee Osteoarthritis
A Phase 4 study testing Ibuprofen, Celecoxib and Diclofenac in people with Knee Osteoarthritis, run by University of Catanzaro at 1 site in Italy.
Trial summary
Central mechanisms may play a role in pain perception during osteoarthritis (OA).Local inflammation (which involves production of pro-inflammatory cytokines such as interleukin (IL) 4 TNF-alpha, IL-6 and IL-8) is considered to be a major source of pain. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Ibuprofen, Celecoxib and Diclofenac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2010to Aug 2011
- Phase
- Phase 4
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for the study were:
- older than 50 years and
- had primary knee OA diagnosed according to the clinical and radiological criteria of the American Rheumatism Association.
- Further inclusion criteria were:
- clinical signs of joint inflammation (warmth, swelling or effusion) and
- a disease severity grade 2 or 3 according to the Kellgren-Lawrence classification
Who cannot join
- allergy to NSAIDs,
- progressive serious medical conditions (such as cancer, AIDS or end-stage renal disease),
- history of gastrointestinal ulcer or bleeding,
- a hemoglobin concentration lower than 11.5 g/dL,
- renal diseases (serum creatinine concentration more than 1.2 times the upper limit of the normal range according to the central laboratory definition reference values), or
- liver dysfunction (serum alanine or aspartate transaminase concentrations more than 1.5 times the upper limit of normal range according to the central laboratory definition reference values).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECTS OF NSAIDs ON CLINICAL OUTCOMES, SYNOVIAL FLUID CYTOKINE CONCENTRATION AND SIGNAL TRANSDUCTION PATHWAYS IN KNEE OSTEOARTHRITIS
Central mechanisms may play a role in pain perception during osteoarthritis (OA).Local inflammation (which involves production of pro-inflammatory cytokines such as interleukin (IL) 4 TNF-alpha, IL-6 and IL-8) is considered to be a major source of pain.
Certain therapies that specifically interfere with the expression or actions of pro-inflammatory cytokines have been explored. NSAIDs have analgesic, antipyretic and anti-inflammatory properties and are extensively prescribed for several musculoskeletal disorders. Indeed, the Osteoarthritis Research Society International (OARSI) recently recommended the use of NSAIDs for management of knee and hip OA in symptomatic patients. These drugs have been shown to influence cytokine metabolism in the synovial fluid of OA patients with satisfactory relief of painful osteoarthritic joints.
The aim of the current study was to explore whether NSAID treatment inhibits TNF-alpha, IL-6, IL-8, and VEGF secretion in the synovial fluid of osteoarthritic joints. In particular, diclofenac, ibuprofen and celecoxib were studied. Under the hypothesis that relationships between proinflammatory cytokines and the clinical status of OA patients are possible, we also evaluated the association between the concentration of these molecules in the osteoarthritic knee synovial fluid and the pain and functional status of patients with OA. The effects of NSAIDS on signal transduction pathways in the synovial membrane were also investigated.
Read the detailed description
not desired
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called Brufen
time of treatment 14 days
CelecoxibDrug
Also called celebrex
time of treatment 14 days
DiclofenacDrug
Also called voltaren
time of treatment 14 days
| Study group | Role | What they receive |
|---|---|---|
| diclofenac 75 mg/day | Active comparator | diclofenac 75 mg once day slow release Receives: Drug: Diclofenac |
| diclofenac 150 mg/day | Active comparator | diclofenac 75 mg bid Receives: Drug: Diclofenac |
| ibuprofen 1200 mg/day | Active comparator | ibuprofen 600 mg bid Receives: Drug: Ibuprofen |
| ibuprofen 1800 mg/day | Active comparator | ibuprofen 600 mg tid Receives: Drug: Ibuprofen |
| celecoxib 200 mg/day | Active comparator | celecoxib 200 mg once day Receives: Drug: Celecoxib |
| celecoxib 400 mg/day | Active comparator | celecoxib 200 mg bid Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster universities (WOMAC) osteoarthritis index score
Womac was used to 77 measure the disease-specific health status of patients before and after the pharmacological treatment.
Measured: 0-14 days
Secondary outcomes (1)
Naranjo probability scale
The Naranjo probability scale was used to evaluate the development of adverse drug reaction during this study
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startApr 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catanzaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Gallelli, University of Catanzaro
- Investigators
- Luca Gallelli, MD, Principal investigator, University of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860833
- Sponsor's protocol ID
- LGOG1
- Acronym
- NSKO
- Status last verified
- May 2013
- First submitted
- 20 May 2013
- Last updated
- 23 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gallelli L, Galasso O, Falcone D, Southworth S, Greco M, Ventura V, Romualdi P, Corigliano A, Terracciano R, Savino R, Gulletta E, Gasparini G, De Sarro G. The effects of nonsteroidal anti-inflammatory drugs on clinical outcomes, synovial fluid cytokine concentration and signal transduction pathways in knee osteoarthritis. A randomized open label trial. Osteoarthritis Cartilage. 2013 Sep;21(9):1400-8. doi: 10.1016/j.joca.2013.06.026.
PubMed 23973155
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF NSAIDs ON CLINICAL OUTCOMES, SYNOVIAL FLUID CYTOKINE CONCENTRATION AND SIGNAL TRANSDUCTION PATHWAYS IN KNEE OSTEOARTHRITIS
- ClinicalTrials.gov ID
- NCT01860833
- Acronym / sponsor ID
- NSKO / LGOG1
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of CatanzaroUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 23 May 2013 (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.
Central mechanisms may play a role in pain perception during osteoarthritis (OA).Local inflammation (which involves production of pro-inflammatory cytokines such as interleukin (IL) 4 TNF-alpha, IL-6 and IL-8) is considered to be a major source of pain.
Certain therapies that specifically interfere with the expression or actions of pro-inflammatory cytokines have been explored. NSAIDs have analgesic, antipyretic and anti-inflammatory properties and are extensively prescribed for several musculoskeletal disorders. Indeed, the Osteoarthritis Research Society International (OARSI) recently recommended the use of NSAIDs for management of knee and hip OA in symptomatic patients. These drugs have been shown to influence cytokine metabolism in the synovial fluid of OA patients with satisfactory relief of painful osteoarthritic joints.
The aim of the current study was to explore whether NSAID treatment inhibits TNF-alpha, IL-6, IL-8, and VEGF secretion in the synovial fluid of osteoarthritic joints. In particular, diclofenac, ibuprofen and celecoxib were studied. Under the hypothesis that relationships between proinflammatory cytokines and the clinical status of OA patients are possible, we also evaluated the association between the concentration of these molecules in the osteoarthritic knee synovial fluid and the pain and functional status of patients with OA. The effects of NSAIDS on signal transduction pathways in the synovial membrane were also investigated.
Detailed description
not desired
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| diclofenac 75 mg/day | Active comparator | Drug: Diclofenacdiclofenac 75 mg once day slow release |
| diclofenac 150 mg/day | Active comparator | Drug: Diclofenacdiclofenac 75 mg bid |
| ibuprofen 1200 mg/day | Active comparator | Drug: Ibuprofenibuprofen 600 mg bid |
| ibuprofen 1800 mg/day | Active comparator | Drug: Ibuprofenibuprofen 600 mg tid |
| celecoxib 200 mg/day | Active comparator | Drug: Celecoxibcelecoxib 200 mg once day |
| celecoxib 400 mg/day | Active comparator | Drug: Celecoxibcelecoxib 200 mg bid |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- older than 50 years and
- had primary knee OA diagnosed according to the clinical and radiological criteria of the American Rheumatism Association.
- clinical signs of joint inflammation (warmth, swelling or effusion) and
- a disease severity grade 2 or 3 according to the Kellgren-Lawrence classification
Key exclusion criteria (6 listed)
- allergy to NSAIDs,
- progressive serious medical conditions (such as cancer, AIDS or end-stage renal disease),
- history of gastrointestinal ulcer or bleeding,
- a hemoglobin concentration lower than 11.5 g/dL,
- renal diseases (serum creatinine concentration more than 1.2 times the upper limit of the normal range according to the central laboratory definition reference values), or
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 |
|---|---|---|
| IbuprofenAlso: Brufentime of treatment 14 days | Drug | ibuprofen 1200 mg/day, ibuprofen 1800 mg/day |
| CelecoxibAlso: celebrextime of treatment 14 days | Drug | celecoxib 200 mg/day, celecoxib 400 mg/day |
| DiclofenacAlso: voltarentime of treatment 14 days | Drug | diclofenac 150 mg/day, diclofenac 75 mg/day |
Primary outcome
Western Ontario and McMaster universities (WOMAC) osteoarthritis index score
Time frame: 0-14 days
Womac was used to 77 measure the disease-specific health status of patients before and after the pharmacological treatment.
1 secondary outcome
Naranjo probability scale
Time frame: 14 days
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 23 May 2013.
- Derived from this study: PubMed 23973155Gallelli L, Galasso O, Falcone D, Southworth S, Greco M, Ventura V, Romualdi P, Corigliano A, Terracciano R, Savino R, Gulletta E, Gasparini G, De Sarro G. The effects of nonsteroidal anti-inflammatory drugs on clinical outcomes, synovial fluid cytokine concentration and signal transduction pathways in knee osteoarthritis. A randomized open label trial. Osteoarthritis Cartilage. 2013 Sep;21(9):1400-8. doi: 10.1016/j.joca.2013.06.026.
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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.
Luca Gallelli, MD principal investigator
University of Catanzaro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibuprofen, Celecoxib and Diclofenac in people with Knee Osteoarthritis, run by University of Catanzaro at 1 site in Italy.
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 6 inclusion and 6 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 23 May 2013. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Western Ontario and McMaster universities (WOMAC) osteoarthritis index score (time frame: 0-14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01860833, which also lists 1 linked publication.
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 23 May 2013.