Efficacy of Duloxetine Compared to NSIADs in Osteoarthritis of Knee (Duloxetine)

March 11, 2023 updated by: Aryan Mohamadfatih Jalal, Hawler Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
      • Erbil, Iraq, 44001
        • Rizgary and Cmc Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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 .
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
Other Names:
  • Cymbalta
Drug: Nonsteroidal Antiinflammatory Drug
patient in this second group will receive NSAID for 3 weeks
Other Names:
  • NSAID
Active Comparator: NSAID(non steroidal anti inflammatory)
patient in the second group will receive NSAID(non-steroidal anti inflammatory) drugs for 13 weeks
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
Other Names:
  • Cymbalta
Drug: Nonsteroidal Antiinflammatory Drug
patient in this second group will receive NSAID for 3 weeks
Other Names:
  • NSAID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
twenty four hour 24-h average pain scores (short form) in patients with osteoarthritis knee pain
Time Frame: follow-up patients within two months
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
Time Frame: follow-up patients within two months
which involve three category about rating of pain(5 item) , stiffness(2item), physical function(17 item
follow-up patients within two months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The other modality (clinical global improvement)
Time Frame: follow-up patients within two months
will be used for severity of modality of pain and therapeutic response even side effect of drug
follow-up patients within two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hawler Medical University

Investigators

  • Principal Investigator: Aryan MF jalal, M.B.CH.B, Rheumatology , Hawler Medical University, Kurdistan Board for medical specialties
  • Study Director: Niaz Albarzinji, MBCHB,DRMR, Rheumatology, Hawler medical university/college of medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2022

Primary Completion (Actual)

December 29, 2022

Study Completion (Actual)

January 2, 2023

Study Registration Dates

First Submitted

July 31, 2022

First Submitted That Met QC Criteria

July 31, 2022

First Posted (Actual)

August 3, 2022

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 11, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Efficacy of Duloxetine

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteo Arthritis Knee

Clinical Trials on Duloxetine 30 MG

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe