Efficacy of Duloxetine Compared to NSIADs in Osteoarthritis of Knee

NCT05486026 | Completed Phase 2

• 1 other identifier: Efficacy of Duloxetine
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee

Keywords

Duloxetine, Osteoarthritis, Kurdistan Region

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• The other modality (clinical global improvement)

  follow-up patients within two months

Study Arms (2)

Duloxetine tablet

ACTIVE COMPARATOR

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; Drug: Nonsteroidal Antiinflammatory Drug

NSAID(non steroidal anti inflammatory)

ACTIVE COMPARATOR

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

Drug: Duloxetine 30 MG; Drug: Nonsteroidal Antiinflammatory Drug

Interventions

Duloxetine 30 MG 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

Also known as: Cymbalta

Duloxetine tablet; NSAID(non steroidal anti inflammatory)

Nonsteroidal Antiinflammatory Drug DRUG

patient in this second group will receive NSAID for 3 weeks

Also known as: NSAID

Duloxetine tablet; NSAID(non steroidal anti inflammatory)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Hawler Medical University: lead

Study Sites (1)

Rizgary and Cmc Hospital

Erbil, 44001, Iraq

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Duloxetine Hydrochloride; Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• Aryan MF jalal, M.B.CH.B

  Rheumatology , Hawler Medical University, Kurdistan Board for medical specialties

  PRINCIPAL INVESTIGATOR

• Niaz Albarzinji, MBCHB,DRMR

  Rheumatology, Hawler medical university/college of medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 31, 2022
• First Posted: August 3, 2022
• Study Start: August 20, 2022
• Primary Completion: December 29, 2022
• Study Completion: January 2, 2023
• Last Updated: March 14, 2023

Record last verified: 2022-11

Locations

IR (1)