Efficacy of Duloxetine Compared to NSIADs in Osteoarthritis of Knee (Duloxetine)
Primary Purpose
Osteo Arthritis Knee
Status
Completed
Phase
Phase 2
Locations
Iraq
Study Type
Interventional
Intervention
Duloxetine 30 MG
Nonsteroidal Antiinflammatory Drug
Sponsored by
About this trial
This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring Duloxetine, Osteoarthritis, Kurdistan Region
Eligibility Criteria
Inclusion Criteria:
- > 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
Exclusion Criteria:
- 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 -
Sites / Locations
- Rizgary and Cmc Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Duloxetine tablet
NSAID(non steroidal anti inflammatory)
Arm Description
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 .
patient in the second group will receive NSAID(non-steroidal anti inflammatory) drugs for 13 weeks
Outcomes
Primary Outcome Measures
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')
(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
Secondary Outcome Measures
The other modality (clinical global improvement)
will be used for severity of modality of pain and therapeutic response even side effect of drug
Full Information
NCT ID
NCT05486026
First Posted
July 31, 2022
Last Updated
March 11, 2023
Sponsor
Hawler Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05486026
Brief Title
Efficacy of Duloxetine Compared to NSIADs in Osteoarthritis of Knee
Acronym
Duloxetine
Official Title
Efficacy of Duloxetine Compared to NSIADs in Osteoarthritis of Knee: A Randomized Open Labelled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 20, 2022 (Actual)
Primary Completion Date
December 29, 2022 (Actual)
Study Completion Date
January 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hawler Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
Keywords
Duloxetine, Osteoarthritis, Kurdistan Region
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Duloxetine tablet
Arm Type
Active Comparator
Arm Description
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 .
Arm Title
NSAID(non steroidal anti inflammatory)
Arm Type
Active Comparator
Arm Description
patient in the second group will receive NSAID(non-steroidal anti inflammatory) drugs for 13 weeks
Intervention Type
Drug
Intervention Name(s)
Duloxetine 30 MG
Other Intervention Name(s)
Cymbalta
Intervention Description
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
Intervention Name(s)
Nonsteroidal Antiinflammatory Drug
Other Intervention Name(s)
NSAID
Intervention Description
patient in this second group will receive NSAID for 3 weeks
Primary Outcome Measure Information:
Title
twenty four hour 24-h average pain scores (short form) in patients with osteoarthritis knee pain
Description
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')
Time Frame
follow-up patients within two months
Title
(WOMAC) WESTERN ONTARIO AND MCMASTER OSTEOARTHITIS INDEX used for evaluation of pain in knee Osteoarthritis
Description
which involve three category about rating of pain(5 item) , stiffness(2item), physical function(17 item
Time Frame
follow-up patients within two months
Secondary Outcome Measure Information:
Title
The other modality (clinical global improvement)
Description
will be used for severity of modality of pain and therapeutic response even side effect of drug
Time Frame
follow-up patients within two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
> 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
Exclusion Criteria:
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aryan MF jalal, M.B.CH.B
Organizational Affiliation
Rheumatology , Hawler Medical University, Kurdistan Board for medical specialties
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Niaz Albarzinji, MBCHB,DRMR
Organizational Affiliation
Rheumatology, Hawler medical university/college of medicine
Official's Role
Study Director
Facility Information:
Facility Name
Rizgary and Cmc Hospital
City
Erbil
ZIP/Postal Code
44001
Country
Iraq
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Duloxetine Compared to NSIADs in Osteoarthritis of Knee
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