Efficacy of Duloxetine Compared to NSIADs in Osteoarthritis of Knee
Study Details
Study Description
Brief Summary
Osteoarthritis (OA) is the most common degenerative joint disease, affecting more than 25% of the population . Knee OA is an insidious disease related to structural changes in the joint over many years. Progressive articular damage results in a loss of the extracellular matrix of cartilage in addition to changes in subchondral bone.
Duloxetine, a selective serotonin, and norepinephrine reuptake inhibitor, it seems to be effective in treating neuropathic and chronic pain conditions.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This will be a 13-week A randomized open labelled clinical trail in Iraqi Kurdistan Region, that will be designed to assess the efficacy of duloxetine tablet compared with other group (Nonsteroidal anti-inflammatory) drug on the reduction of pain caused by osteoarthritis of the knee.
Patients will be divided into two groups, first group (case) will receive duloxetine tablet 30mg for two weeks then titrated up to duloxetine 30mg BID. Patients will be instructed to take the medication with meals. Patients will be observed at visits (0) baseline then at second visits at 13 weeks then will be compared to control group that will receive NSAID (nonsteroidal anti-inflammatory drug) at baseline (0) visit then 2nd visits at 13 weeks.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Duloxetine tablet Patient in the first group (case) will receive duloxetine tablet 30mg for two weeks then titrated up to duloxetine 30mg BID. Patients will be instructed to take the medication with meals for 13 weeks . |
Drug: Duloxetine 30 MG
patient in first group (case) will receive duloxetine tablet 30mg for two weeks then titrated up to duloxetine 30mg BID. Patients will be instructed to take the medication with meals. The for 13 weeks
Other Names:
Drug: Nonsteroidal Antiinflammatory Drug
patient in this second group will receive NSAID for 3 weeks
Other Names:
|
| Active Comparator: NSAID(non steroidal anti inflammatory) patient in the second group will receive NSAID(non-steroidal anti inflammatory) drugs for 13 weeks |
Drug: Duloxetine 30 MG
patient in first group (case) will receive duloxetine tablet 30mg for two weeks then titrated up to duloxetine 30mg BID. Patients will be instructed to take the medication with meals. The for 13 weeks
Other Names:
Drug: Nonsteroidal Antiinflammatory Drug
patient in this second group will receive NSAID for 3 weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- twenty four hour 24-h average pain scores (short form) in patients with osteoarthritis knee pain [follow-up patients within two months]
it will report in patients' diaries based on the 11-point Likert scale (an ordinal scale with 0 indicating 'no pain', and 10 indicating 'worst pain imaginable')
- (WOMAC) WESTERN ONTARIO AND MCMASTER OSTEOARTHITIS INDEX used for evaluation of pain in knee Osteoarthritis [follow-up patients within two months]
which involve three category about rating of pain(5 item) , stiffness(2item), physical function(17 item
Secondary Outcome Measures
- The other modality (clinical global improvement) [follow-up patients within two months]
will be used for severity of modality of pain and therapeutic response even side effect of drug
Eligibility Criteria
Criteria
Inclusion Criteria:
-
40years of age
-
both Genders
-
who will meet the American College of Rheumatology clinical and radiographic criteria for the diagnosis of osteoarthritis of the knee
-
with pain for ≥14days of each separate month for 3months before study entry, with a mean score ≥4 on the 24-h average pain score (0-10) using the average of daily ratings
Exclusion Criteria:
-
if they have diagnosed with inflammatory arthritis or an autoimmune disease
-
if they received invasive therapy in last 3 months (knee arthroscopy) or knee replacement at any time
-
patients with psychiatric disorders
-
Hypertension
-
Heart disease
-
patients on antipsychotics or anti-depressant -
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Hawler Medical University
Investigators
- Principal Investigator: Aryan MF jalal, M.B.CH.B, Rheumatology , Hawler Medical University, Kurdistan Board for medical specialties
- Study Director: Niaz Albarzinji, MBCHB,DRMR, Rheumatology, Hawler medical university/college of medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Efficacy of Duloxetine