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Trial record 19 of 603 for:    ESCITALOPRAM

Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia (CORTEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03487211
Recruitment Status : Completed
First Posted : April 3, 2018
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
DR. MOHAMMAD ALI ARIF, Shaheed Zulfiqar Ali Bhutto Medical University

Tracking Information
First Submitted Date  ICMJE March 27, 2018
First Posted Date  ICMJE April 3, 2018
Last Update Posted Date February 27, 2020
Actual Study Start Date  ICMJE April 9, 2018
Actual Primary Completion Date February 26, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2018)
Reduction in FIQ-R (Revised Fibromyalgia Impact Questionnaire) from baseline [ Time Frame: 4,8 and 12 weeks ]
Percentage decrease in FIQ-R from baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia
Official Title  ICMJE Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia
Brief Summary Duloxetine is FDA approved as pharmacological treatment for Fibromyalgia. The use of SSRIs has been endorsed by the 2013 Canadian guidelines. The data available for Escitalopram as a treatment modality for Fibromyalgia is limited, however small trials have demonstrated its efficacy. No head to head comparisons between escitalopram and duloxetine have been undertaken. We aim to conduct a single blind, randomized control trial to assess the comparative efficacy of duloxetine vs escitalopram in drug naive patients with newly diagnosed Fibromyalgia.
Detailed Description 180 drug naive patients with newly diagnosed fibromyalga according to the modified ACR 2016 criteria shall be enrolled by consecutive sampling after taking written informed consent. Baseline severity of fibromyalgia shall be assessed via the Revised Fibromyalgia Impact Questionnaire (FIQ-R). They shall be randomized via cluster randomization into two groups. The first group shall receive Duloxetine 30mg, will be increased to 60mg after one week. The second group shall receive Escitalopram 10mg to be increased to 20mg after one week. Patients shall be followed at 0,2,4,8 and 12 weeks. At each visit, any subjective change in symptoms shall be noted and the FIQ-R shall be re administered. At the end of the trial, the overall change in the FIQ-R from baseline shall be assessed and the difference between both groups will be analyzed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized Control Trial
Masking: Single (Participant)
Masking Description:
Patients shall be provided medication with numeric labels
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Drug: Duloxetine
    Duloxetine 30mg PO once daily for 1 week followed by an increase to 60mg PO once daily
    Other Name: DUPREX
  • Drug: Escitalopram
    Escitalopram 10mg PO once daily for 1 week followed by an increase to 20mg PO once daily
    Other Name: EXAPRO
Study Arms  ICMJE
  • Active Comparator: Duloxetine Group
    Duloxetine 30mg once daily to be started for 1 week. Dose will then be titrated to 60mg once daily and the patients followed for a total of 12 weeks.
    Intervention: Drug: Duloxetine
  • Experimental: Escitalopram Group
    Escitalopram 10mg once daily to be started for 1 week. Dose will then be titrated to 20mg once daily and the patients followed for a total of 12 weeks.
    Intervention: Drug: Escitalopram
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2020)
200
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2018)
180
Actual Study Completion Date  ICMJE February 26, 2020
Actual Primary Completion Date February 26, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Drug Naive patients
  • Newly diagnosed with FIbromyalgia according to Modified ACR 2016 criteria

Exclusion Criteria:

  • Concomitant depression/bipolar disorder or any other documented psychiatric illness
  • Autoimmune disorders (SLE, RA)
  • Peripheral Neuropathic pain due to any cause
  • Uncontrolled hypertension
  • Impaired renal or hepatic functions (on Lab assay)
  • Chronic infections (e.g.Tuberculosis)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03487211
Other Study ID Numbers  ICMJE ShaheedZABMU
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party DR. MOHAMMAD ALI ARIF, Shaheed Zulfiqar Ali Bhutto Medical University
Study Sponsor  ICMJE Shaheed Zulfiqar Ali Bhutto Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohammad A Arif, MRCP, FRCP Shaheed Zulfiqar Ali Bhutto Medical University
PRS Account Shaheed Zulfiqar Ali Bhutto Medical University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP