Efficacy of Duloxetine Compared to NSIADs in Osteoarthritis of Knee

NCT ID: NCT05486026

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-20
• Study Completion Date: 2023-01-02

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.

Conditions

Osteo Arthritis Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 .

Group Type: ACTIVE_COMPARATOR

Duloxetine 30 MG

Intervention Type: DRUG

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

Intervention Type: DRUG

patient in this second group will receive NSAID for 3 weeks

NSAID(non steroidal anti inflammatory)

patient in the second group will receive NSAID(non-steroidal anti inflammatory) drugs for 13 weeks

Group Type: ACTIVE_COMPARATOR

Duloxetine 30 MG

Intervention Type: DRUG

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

Intervention Type: DRUG

patient in this second group will receive NSAID for 3 weeks

Interventions

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

Intervention Type: DRUG

Nonsteroidal Antiinflammatory Drug

patient in this second group will receive NSAID for 3 weeks

Intervention Type: DRUG

Other Intervention Names

Cymbalta; NSAID

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 -

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hawler Medical University

OTHER

Sponsor Role: lead

Responsible Party

Aryan Mohamadfatih Jalal

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aryan MF jalal, M.B.CH.B

Role: PRINCIPAL_INVESTIGATOR

Rheumatology , Hawler Medical University, Kurdistan Board for medical specialties

Niaz Albarzinji, MBCHB,DRMR

Role: STUDY_DIRECTOR

Rheumatology, Hawler medical university/college of medicine

Locations

Rizgary and Cmc Hospital

Erbil, , Iraq

Countries

Iraq

Other Identifiers

Efficacy of Duloxetine

Identifier Type: -

Identifier Source: org_study_id