The goal of the study is comparison of duloxetine and pregabalin effects on invalidation score and depression in patients with fibromyalgia.
Design
open-label randomized clinical trial
Settings and conduct
This study will be conducted in subspecialty clinic of Razi hospital of Rasht under a rheumatology specialist. Diagnosis of patients is based on ACR 2010. All patients will complete and sign informed consent, then the patients will be randomized into two groups using random blocks of allocation. Patients will complete the inventories of illness invalidation, beck depression and FIQR in starting of the study and 1 month later. All data will be analyzed by special statistical softwares.
Participants/Inclusion and exclusion criteria
Inclusion criteria:female,patients must meet the American College of Rheumatology criteria for fibromyalgia(ACR2010) and rheumatologist confirm fibromyalgia diagnosis.
Exclusion criteria:age younger than 18 or older than 65 years old, pregnancy or plans to become pregnant, taking MAOIs, chronic disease, history of sensitivity to Pregabalin and Duloxetine .
Intervention groups
Two groups of fibromyalgia patients: one group receive duloxetine capsules 30 mg daily initially, and finally 60 mg daily from Lilly's Pharmaceutical Company, and the other group receive pregabalin 75 mg initially and finally 150 mg daily from Pfizer company.
Main outcome variables
Invalidation in patient with fibromyalgia;Beck depression score in patient with fibromyalgia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181113041646N1
Registration date:2019-11-05, 1398/08/14
Registration timing:prospective
Last update:2019-11-05, 1398/08/14
Update count:0
Registration date
2019-11-05, 1398/08/14
Registrant information
Name
Ashkan Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3467 2363
Email address
ashkan96shamami@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-21, 1398/08/30
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of duloxetine and pregabalin Effects on invalidation score and depression in Patients with Fibromyalgia.
Public title
Effect of duloxetine and pregabalin on invalidation in fibromyalgia.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female .
Patients must meet the American College of Rheumatology criteria for fibromyalgia (ACR2010).
A rheumatologist confirm diagnosis of fibromyalgia.
Exclusion criteria:
Age younger than 18 or older than 65 years old
Pregnancy .
Taking MAOIs (monoamine oxidase inhibitors) in the 14 days before study.
Cases of chronic liver disease, severe renal failure and uncontrolled narrow angle glaucoma.
History of sensitivity to Pregabalin and its components.
History of sensitivity to Duloxetine and its components.
Age
From 18 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized allocation with block method by statistical software .
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of guilan university of medical sciences
Street address
Rasht,Namjoo avenue,shahid siadati street,infront of 17shahrivar hospital
City
Rasht
Province
Guilan
Postal code
4144895655
Approval date
2019-07-21, 1398/04/30
Ethics committee reference number
IR.GUMS.REC.1398.208
Health conditions studied
1
Description of health condition studied
Invalidation in patient with fibromyalgia
ICD-10 code
M79.7
ICD-10 code description
Fibromyalgia
Primary outcomes
1
Description
Invalidation in patient with fibromyalgia.
Timepoint
Before starting the study, then one month after taking medication.
Method of measurement
Illness invalidation questionnaire.
2
Description
Depression score in Beck depression inventory.
Timepoint
Before starting the study,then one month after taking medication.
Method of measurement
Beck depression questionnaire.
Secondary outcomes
1
Description
severity of disease
Timepoint
Before starting the study, then one month after taking medication.
Method of measurement
FIQR Questionnaire
Intervention groups
1
Description
Intervention group: Group one includes patients diagnosed with fibromyalgia receiving duloxetine with the initial dose of 30 mg daily in form of oral capsule for one month. The dose will be increased up to 60 mg daily after 1 week depending on tolerance. Duloxetine (Cymbalta (Lilly company – USA) is a serotonine and norepinephrine reuptake inhibitor with formula of C18H19NOS. It can be administered either before or after meals.
Category
Treatment - Drugs
2
Description
Intervention group2: Group two includes patients diagnosed with fibromyalgia receiving Pregabalin capsule orally with the initial dose of 75 mg daily for one month .the dose will be increased up to 150 mg daily after 1week depending on tolerance.. Pregabalin ( Lyrica (Pfizer – USA) )has the formula of C8H17NO2 and its active metabolite is N-methyl pregabalin.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital clinic
Full name of responsible person
Banafsheh gavidel parsa
Street address
Esteghamat avenue.,razi clinic tower
City
Rasht
Province
Guilan
Postal code
4144895655
Phone
+98 13 3353 0169
Email
Bghavidelparsa@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shadman nemati
Street address
Rasht,Namjoo avenue,shahid siadati street,infrint of 17shahrivar hospital
City
Rasht
Province
Guilan
Postal code
4144895655
Phone
+98 13 3333 6394
Email
Bghavidelparsa@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Banafshe Ghavidel parsa
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Sardr jangal avenue ,razi hospital
City
Rasht
Province
Guilan
Postal code
4144895655
Phone
+98 13 3353 0169
Email
Bghavidelparsa@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Banafsheh ghavidel parsa
Position
Medical student
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Sardare jangal avenue,Razi hospital
City
Rasht
Province
Guilan
Postal code
4144895655
Phone
+98 13 3353 0169
Email
Bghavidelparsa@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Banafsheh Ghavidelparsa
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Education
Street address
Sardare jangal avenue ,razi hospital
City
Rasht
Province
Guilan
Postal code
4144895655
Phone
+98 13 3353 0169
Email
Ashkan96shamami@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available