Efficacy of Duloxetine Compared to NSIADs in Osteoarthritis of Knee

Study Overview
=================
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.

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.

Official Title
-----------------
Efficacy of Duloxetine Compared to NSIADs in Osteoarthritis of Knee: A Randomized Open Labelled Clinical Trial

Conditions
-----------------
Osteo Arthritis Knee

Intervention / Treatment
-----------------
* Drug: Duloxetine 30 MG
* Drug: Nonsteroidal Antiinflammatory Drug


Participation Criteria
=================
Eligibility 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 -

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Duloxetine tablet<br>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<br>* 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<br>* Other names: Cymbalta;Drug: Nonsteroidal Antiinflammatory Drug<br>* patient in this second group will receive NSAID for 3 weeks<br>* Other names: NSAID;|
| Active Comparator: NSAID(non steroidal anti inflammatory)<br>patient in the second group will receive NSAID(non-steroidal anti inflammatory) drugs for 13 weeks | Drug: Duloxetine 30 MG<br>* 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<br>* Other names: Cymbalta;Drug: Nonsteroidal Antiinflammatory Drug<br>* patient in this second group will receive NSAID for 3 weeks<br>* Other names: NSAID;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| twenty four hour 24-h average pain scores (short form) in patients with osteoarthritis knee pain | 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') | follow-up patients within two months | 
| (WOMAC) WESTERN ONTARIO AND MCMASTER OSTEOARTHITIS INDEX used for evaluation of pain in knee Osteoarthritis | which involve three category about rating of pain(5 item) , stiffness(2item), physical function(17 item | follow-up patients within two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The other modality (clinical global improvement) | will be used for severity of modality of pain and therapeutic response even side effect of drug | follow-up patients within two months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Duloxetine, Osteoarthritis, Kurdistan Region