Efficacy of Duloxetine Compared to NSIADs in Osteoarthritis of Knee

Osteo Arthritis Knee Clinical Trial

— Duloxetine  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05486026
• Other study ID #: Efficacy of Duloxetine
• Status: Completed
• Phase: Phase 2
• Start date: August 20, 2022
• Est. completion date: January 2, 2023

Study information

• Verified date: November 2022
• Source: Hawler Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 2, 2023
• Est. primary completion date: December 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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
• Nonsteroidal Antiinflammatory Drug
patient in this second group will receive NSAID for 3 weeks

Locations

Country	Name	City	State
Iraq	Rizgary and Cmc Hospital	Erbil

Sponsors (1)

Lead Sponsor	Collaborator
Hawler Medical University

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	(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	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