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Clinical trial

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

ID
Name
Efficacy of Duloxetine
Description
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.
Trial arms
Trial start
2022-08-20
Estimated PCD
2022-12-29
Trial end
2023-01-02
Status
Completed
Phase
Early phase I
Treatment
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
Arms:
Duloxetine tablet, NSAID(non steroidal anti inflammatory)
Other names:
Cymbalta
Nonsteroidal Antiinflammatory Drug
patient in this second group will receive NSAID for 3 weeks
Arms:
Duloxetine tablet, NSAID(non steroidal anti inflammatory)
Other names:
NSAID
Size
200
Primary endpoint
twenty four hour 24-h average pain scores (short form) in patients with osteoarthritis knee pain
follow-up patients within two months
(WOMAC) WESTERN ONTARIO AND MCMASTER OSTEOARTHITIS INDEX used for evaluation of pain in knee Osteoarthritis
follow-up patients within two months
Eligibility criteria
Inclusion Criteria: 1. \> 40years of age 2. both Genders 3. who will meet the American College of Rheumatology clinical and radiographic criteria for the diagnosis of osteoarthritis of the knee 4. 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: 1. if they have diagnosed with inflammatory arthritis or an autoimmune disease 2. if they received invasive therapy in last 3 months (knee arthroscopy) or knee replacement at any time 3. patients with psychiatric disorders 4. Hypertension 5. Heart disease 6. patients on antipsychotics or anti-depressant -
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 200, 'type': 'ACTUAL'}}
Updated at
2023-03-14

1 organization

2 products

1 indication

Organization
Hawler Medical University
Product
Duloxetine
Indication
Osteoarthritis of the Knee
Product
Nonsteroidal Antiinflammatory Drug