Considering that antidepressants have an effect on the improvement of patients' pain and can also have an effect on the quality of life, so the purpose of this study is to compare the effectiveness of Duloxetine and Nortriptyline to in treating the pain in Rheumatoid Arthritis patients.
Design
Clinical trial, with parallel groups, phase 3, double blind, randomized on 54 patients, randomization by Permuted Block Randomization
Settings and conduct
Rheumatoid arthritis patients who visited the rheumatology clinic of Imam Hossein (AS) hospital in 1401 and 1402 and complained of pain were randomly assigned to two groups receiving Duloxetine and Nortriptyline. The study will be conducted in a double-blind manner so that both the patients and the prescribing physician will be completely unaware of the nature of the prescribed medication and how the groups will be randomized. Patients in each group will receive the drug for 3 months. The intensity of pain before the intervention and after one, two and three months of the intervention will be measured with a Visual Analogue Scale.
Participants/Inclusion and exclusion criteria
Age over 18 years; Clinical diagnosis of Rheumatoid Arthritis; Presence of Anti CCP or RF in serum; patients treated with Methotrexate, Hydroxychloroquine, and Prednisolone; articular involvement without extra-articular involvement; complaints of pain; absence of pregnancy and breastfeeding; absence of major psychiatric illness; age less than 70 years; absence of allergy to Nortriptyline and Duloxetine
Intervention groups
After selection, based on the inclusion and exclusion criterias, the patients will be placed in two groups of consumer of Nortriptyline or Duloxetine for 3 months.
Main outcome variables
Pain level based on Visual Analogue Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220901055848N1
Registration date:2023-02-18, 1401/11/29
Registration timing:registered_while_recruiting
Last update:2023-02-18, 1401/11/29
Update count:0
Registration date
2023-02-18, 1401/11/29
Registrant information
Name
Fateme Kazemi Khaledi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8809 9294
Email address
fkazemikhaledi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-09, 1401/11/20
Expected recruitment end date
2024-02-09, 1402/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of duloxetine and nortriptyline in the treatment of pain in rheumatoid arthritis patients
Public title
Comparison of the effectiveness of duloxetine and nortriptyline in the treatment of pain in rheumatoid arthritis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of the clinical diagnosis of mild to moderate Rheumatoid Arthritis by a rheumatologist
Presence of RF or AntiCCP in the serum of patients
Patients under treatment with methotrexate, prednisolone and hydroxychloroquine
Articular involvement without extra-articular involvement
Age range from 18 to 70 years
Pain complaint
Consent to participate in the study
Exclusion criteria:
The presence of major psychiatric disorders, including depression, anxiety disorders, bipolar, schizophrenia, abuse of any substance and medication.
History of allergy to Duloxetine or Nortriptyline
Pregnancy, breastfeeding, or planning to become pregnant in the near future
Refusing to consent to receive treatment according to the instructions of this protocol
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
The 4 random blocks are used. Each label has a letter A or B and the random sequence method is created using the website www.sealedenvelope.com using the random block method of 4 based on treatment group A or B for 54 (two groups of 27) patients.
Block randomization works by randomizing participants into blocks, so that equal numbers are assigned to each treatment. For example, given a block size of 4, there are 6 possible ways to equally assign participants to a block.
Blinding (investigator's opinion)
Double blinded
Blinding description
Nortriptyline and Duloxetine drugs with similar packaging, with different codes from the combination of numbers and letters A and B are used. Each patient is assigned a code at the beginning of the study, which is known by that code until the end of the study. Both the patients and the prescribing doctor are unaware of the patient grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Shahid Beheshti University of Medical Sciences (Faculty of Medicine)
Street address
Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Approval date
2022-12-24, 1401/10/03
Ethics committee reference number
IR.SBMU.MSP.REC.1401.482
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain level
Timepoint
Pain measurement before, 1 month, 2 months and 3 months after the start of taking one of the two drugs Nortriptyline and Duloxetine
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: will be treated with Nortriptyline 10 mg of Abidi company on a daily basis; which is based on the clinical response of pain reduction (which is based on previous clinical trials a reduction of more than 30% in the baseline VAS score) for patients who did not achieve a clinical response in subsequent visits up to the maximum daily dose of 150 mg will be considered. The treatment will be done for 3 months. In order to follow up, patients will be visited 1 month, 2 months and 3 months later. And pain intensity will be measured using VAS in each of these visits.
Category
Treatment - Drugs
2
Description
Intervention group 2: will be treated with Duloxetine 20 mg of Abidi company on a daily basis; which is based on the clinical response of pain reduction (which is based on previous clinical trials a reduction of more than 30% in the baseline VAS score) for patients who did not achieve a clinical response in subsequent visits up to the maximum daily dose of 120 mg will be considered. The treatment will be done for 3 months. In order to follow up, patients will be visited 1 month, 2 months and 3 months later. And pain intensity will be measured using VAS in each of these visits.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Roya Vaziri Harami
Street address
Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
info.rhmc@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Daneshjoo Blvd., Velenjak St., Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9770
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roya Vaziri Harami
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
roya832003@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roya Vaziri Harami
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
roya832003@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fateme Kazemi Khaledi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
fatemekazemikhaledi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-aidentifying individuals.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
All researchers working in academic and scientific institutions, doctors and pharmaceutical companies will be allowed to access the information.
Under which criteria data/document could be used
The applicant can access the information after providing proof of identity
From where data/document is obtainable
The applicant can contact Dr. Fateme Kazemi Khaledi via e-mail: fatemekazemikhaledi@gmail.com to receive the desired documents or data.
What processes are involved for a request to access data/document
The applicant can communicate with the researcher through e-mail and receive the basic data after presenting the identity documents.