Clinical trial NCT05486026: Efficacy of Duloxetine Compared to NSIADs in Osteoarthritis of Knee
Official title: Efficacy of Duloxetine Compared to NSIADs in Osteoarthritis of Knee: A Randomized Open Labelled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteo Arthritis Knee
Keywords: Duloxetine, Osteoarthritis, Kurdistan Region
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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 -

Primary outcomes:
measure: twenty four hour 24-h average pain scores (short form) in patients with osteoarthritis knee pain
timeFrame: follow-up patients within two months
measure: (WOMAC) WESTERN ONTARIO AND MCMASTER OSTEOARTHITIS INDEX used for evaluation of pain in knee Osteoarthritis
timeFrame: follow-up patients within two months
Secondary outcomes:
measure: The other modality (clinical global improvement)
timeFrame: follow-up patients within two months
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Rizgary and Cmc Hospital
Study officials:
affiliation: Rheumatology , Hawler Medical University, Kurdistan Board for medical specialties
name: Aryan MF jalal, M.B.CH.B
role: PRINCIPAL_INVESTIGATOR
affiliation: Rheumatology, Hawler medical university/college of medicine
name: Niaz Albarzinji, MBCHB,DRMR
role: STUDY_DIRECTOR
References: