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Osteo Arthritis KneePhase 2DuloxetineNCT05486026

Efficacy of Duloxetine Compared to NSIADs in Osteoarthritis of Knee

A Phase 2 study testing Duloxetine 30 MG and Nonsteroidal Antiinflammatory Drug in people with Osteo Arthritis Knee, run by Hawler Medical University at 1 site in Iraq.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Osteo Arthritis Knee
What is being tested?
Duloxetine 30 MG and Nonsteroidal Antiinflammatory Drug
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteIraq
Study dates
20 Aug 2022to 2 Jan 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • > 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

Who cannot join

  • 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 -

Trial locations and contacts

1 site in 1 country.

Iraq1 site

  • Rizgary and Cmc Hospital

    Erbil, 44001

Other trials in Iraq

About this study

Official title: 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.

Read the 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.

Being tested
Duloxetine 30 MG, Nonsteroidal Antiinflammatory Drug
Keywords
Duloxetine, Osteoarthritis, Kurdistan Region
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Duloxetine 30 MGDrug

    Also called Cymbalta

    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 DrugDrug

    Also called NSAID

    patient in this second group will receive NSAID for 3 weeks

Study groups in NCT05486026
Study groupRoleWhat they receive
Duloxetine tabletActive comparatorPatient 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 .
Receives: Drug: Duloxetine 30 MG; Drug: Nonsteroidal Antiinflammatory Drug
NSAID(non steroidal anti inflammatory)Active comparatorpatient in the second group will receive NSAID(non-steroidal anti inflammatory) drugs for 13 weeks
Receives: Drug: Duloxetine 30 MG; Drug: Nonsteroidal Antiinflammatory Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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')

    Measured: follow-up patients within two months

  2. (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

    Measured: follow-up patients within two months

Secondary outcomes (1)

  1. The other modality (clinical global improvement)

    will be used for severity of modality of pain and therapeutic response even side effect of drug

    Measured: follow-up patients within two months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2022
  2. Study start20 Aug 2022
  3. Primary completion29 Dec 2022
  4. Study completion2 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05486026
Sponsor's protocol ID
Efficacy of Duloxetine
Acronym
Duloxetine
Status last verified
Nov 2022
First submitted
31 Jul 2022
Last updated
14 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Duloxetine 30 MG and Nonsteroidal Antiinflammatory Drug in people with Osteo Arthritis Knee, run by Hawler Medical University at 1 site in Iraq.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

twenty four hour 24-h average pain scores (short form) in patients with osteoarthritis knee pain (time frame: follow-up patients within two months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05486026.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.

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