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AzTrials

FibromyalgiaPhase 2/3CORTEXNCT03487211

Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia

A Phase 2/3 study testing Duloxetine and Escitalopram in people with Fibromyalgia, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.

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

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Fibromyalgia
What is being tested?
Duloxetine and Escitalopram
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 sitePakistan
Study dates
9 Apr 2018to 26 Feb 2020
Phase
Phase 2/3
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Pakistan Institute of Medical Sciences

    Islamabad, Islamabad, 44000

Other trials in Pakistan

About this study

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.

Read the 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.

Conditions
Fibromyalgia
Keywords
Fibromyalgia treatment, Duloxetine, Escitalopram
Medical subject headings
Fibromyalgia

What participants receive

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

  • DuloxetineDrug

    Also called DUPREX

    Duloxetine 30mg PO once daily for 1 week followed by an increase to 60mg PO once daily

  • EscitalopramDrug

    Also called EXAPRO

    Escitalopram 10mg PO once daily for 1 week followed by an increase to 20mg PO once daily

Study groups in NCT03487211
Study groupRoleWhat they receive
Duloxetine GroupActive comparatorDuloxetine 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.
Receives: Drug: Duloxetine
Escitalopram GroupExperimentalEscitalopram 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.
Receives: Drug: Escitalopram

What is being measured

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

  1. Reduction in FIQ-R (Revised Fibromyalgia Impact Questionnaire) from baseline

    Percentage decrease in FIQ-R from baseline

    Measured: 4,8 and 12 weeks

Timeline

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

  1. First posted3 Apr 2018
  2. Study start9 Apr 2018
  3. Primary completion26 Feb 2020
  4. Study completion26 Feb 2020

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Control Trial
Masking
Single blind
Who is masked
Participant
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03487211
Sponsor's protocol ID
ShaheedZABMU
Acronym
CORTEX
Status last verified
Feb 2020
First submitted
27 Mar 2018
Last updated
27 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bennett RM, Bushmakin AG, Cappelleri JC, Zlateva G, Sadosky AB. Minimal clinically important difference in the fibromyalgia impact questionnaire. J Rheumatol. 2009 Jun;36(6):1304-11. doi: 10.3899/jrheum.081090. Epub 2009 Apr 15.

    PubMed 19369473

  • Wright CL, Mist SD, Ross RL, Jones KD. Duloxetine for the treatment of fibromyalgia. Expert Rev Clin Immunol. 2010 Sep;6(5):745-56. doi: 10.1586/eci.10.64.

    PubMed 20828282

  • Smith HS, Bracken D, Smith JM. Pharmacotherapy for fibromyalgia. Front Pharmacol. 2011 Mar 31;2:17. doi: 10.3389/fphar.2011.00017. eCollection 2011.

    PubMed 21772818

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Duloxetine and Escitalopram in people with Fibromyalgia, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.

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 2 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 27 Feb 2020. 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 Pakistan. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Reduction in FIQ-R (Revised Fibromyalgia Impact Questionnaire) from baseline (time frame: 4,8 and 12 weeks). 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 NCT03487211, which also lists 3 linked publications.

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 27 Feb 2020.

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