FibromyalgiaPhase 3NCT00552682
Pilot, Opened, Randomized Clinical Trial to Assess the Efficacy of Duloxetine in the Treatment of Fibromialgy in Patients With Infection by HIV 1+
A Phase 3 study testing Duloxetine 60 mg, QD in people with Fibromyalgia and HIV-1 Infection, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial summary
The purpose of this study is to compare duloxetine with conventional treatment of pain in HIV-1 infected patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fibromyalgia, HIV-1 Infection
- What is being tested?
- Duloxetine 60 mg, QD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2007to Jul 2009
- Phase
- Phase 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
- Patients aged 18 years old and more. Age +18 years old.
- Documented HIV-1-infection.
- Former diagnosis of fibromialgy.
- History of good compliance with visit schedule and medication intake.
- Patients voluntary signed the informed consent.
Who cannot join
- Pregnant or breast-feeding females
- Suspicion of intolerance to duloxetine.
- History of any clinical condition that, in the Investigator's criteria, could potentially reoccur with the suggested change of therapy (sarcoma, lymphoma, etc).
- Concomitant condition that could mimic fibromialgy (lupus, endocrine diseases, muscular diseases, multiple sclerosis)
- or Acute illness within 15 days prior to the inclusion
- Patients with major depressive disorder with psychotic symptoms, major depressive disorder melancholic type or bipolar disorder. Patients with other depressive disorders can be included (dysthymic disorder and depressive disorder NOS)
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- Anorexia or nervous bulimia
- History or suspected drug or alcohol abuse.
- Glaucoma
- History of heart disease including cardiac arrhythmias
- Severe obesity (body mass index > 45).
- Concomitant medication with IMAOS, cimetidine or quinolonas
- Patients with hepatic or renal serious failure (Creatinin clearance <30 ml/min)
- Patients with Hypericum perforatum as a concomitant treatment.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare duloxetine with conventional treatment of pain in HIV-1 infected patients.
Read the detailed description
Among HIV-1-infected patients, diagnosis of fibromialgy has increased over the last years . Appropriate identification of firomialgy in these patients is challenging and sometimes can be more complicated than in HIV-negative population. Concomitant infectious processes and symptoms due to HIV infection itself need to be ruled out before establishing a formal diagnosis.
The treatment of this disease frequently includes muscular relaxants , pain-killers, anti-inflammatories and antidepressives despite no drug is formally indicated for this pathology.
Duloxetine approved indications include both treatment of major depressive disorders (MDD) and diabetic neuropathic pain. Recent studies in HIV negative patients show efficacy to control pain and depressive symptoms in patients with fibromialgy The main purpose of this pilot study is to assess the efficacy of duloxetine in HIV-1-infected patients with fibromialgy.
The main purpose of this pilot study is to assess the efficacy of duloxetine in HIV-1-infected patients with fibromialgy or chronic fatigue syndrome presenting with widespread pain.
- Conditions
- Fibromyalgia, HIV-1 Infection
- Being tested
- Duloxetine 60 mg, QD
- Keywords
- HIV, fibromialgy, chronic fatigue syndrome, duloxetine, pain, treatment experienced, Fibromialgy in patients with HIV-1 infection
- Medical subject headings
- Fibromyalgia, Fatigue Syndrome, Chronic, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duloxetine 60 mg, QDDrug
Also called Xeristar
Duloxetine 60 mg, 1 table/day, 1 year
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Duloxetine 60 mg, 1 tablet/day Receives: Drug: Duloxetine 60 mg, QD |
| B | No intervention | To continue with the antidepressive treatment if exist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in pain measured using the Brief Pain Inventory questionnaire in both branches of the study
Measured: Time frame: basal visit, weeks 4, 12, 24, 36 and 48
Secondary outcomes (5)
Assess differences in Short-Form 36 Health Survey (SF-36) questionnaire scale score.
Measured: basal visit, weeks 12, 24 and 48
Assess differences in Beck Depression Inventory (BDI) questionnaire scale score.
Measured: basal visit, weeks 12, 24 and 48
Assess differences in Profile of Mood States - Forma A (POMS-A) questionnaire scale score.
Measured: basal visit, weeks 12, 24 and 48
Assess the percentage of patients that leave duloxetine due to intolerance or toxicity.
Measured: basal visit, weeks 4, 12, 24, 36 and 48
Assess, if possible, pharmacokinetic profile of duloxetine and determine interaction with antiretroviral drugs.
Measured: basal visit, weeks 4, 12, 24, 36 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2007 (estimated)
- Study startJan 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Responsible party
- Sponsor
- Investigators
- Negredo Eugenia, MD,PhD, Principal investigator, Lluita contra la Sida Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552682
- Sponsor's protocol ID
- FIBROHIV
- Status last verified
- Dec 2019
- First submitted
- 31 Oct 2007
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Opened, Randomized Clinical Trial to Assess the Efficacy of Duloxetine in the Treatment of Fibromialgy in Patients With Infection by HIV 1+
- ClinicalTrials.gov ID
- NCT00552682
- Acronym / sponsor ID
- FIBROHIV
- Conditions
- Fibromyalgia, HIV-1 Infection
- Keywords
- HIV, fibromialgy, chronic fatigue syndrome, duloxetine, pain, treatment experienced, Fibromialgy in patients with HIV-1 infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Collaborators
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Study start
- Jan 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 2 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare duloxetine with conventional treatment of pain in HIV-1 infected patients.
Detailed description
Among HIV-1-infected patients, diagnosis of fibromialgy has increased over the last years . Appropriate identification of firomialgy in these patients is challenging and sometimes can be more complicated than in HIV-negative population. Concomitant infectious processes and symptoms due to HIV infection itself need to be ruled out before establishing a formal diagnosis.
The treatment of this disease frequently includes muscular relaxants , pain-killers, anti-inflammatories and antidepressives despite no drug is formally indicated for this pathology.
Duloxetine approved indications include both treatment of major depressive disorders (MDD) and diabetic neuropathic pain. Recent studies in HIV negative patients show efficacy to control pain and depressive symptoms in patients with fibromialgy The main purpose of this pilot study is to assess the efficacy of duloxetine in HIV-1-infected patients with fibromialgy.
The main purpose of this pilot study is to assess the efficacy of duloxetine in HIV-1-infected patients with fibromialgy or chronic fatigue syndrome presenting with widespread pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Duloxetine 60 mg, QDDuloxetine 60 mg, 1 tablet/day |
| B | No intervention | –To continue with the antidepressive treatment if exist |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 years old and more. Age +18 years old.
- Documented HIV-1-infection.
- Former diagnosis of fibromialgy.
- History of good compliance with visit schedule and medication intake.
- Patients voluntary signed the informed consent.
Key exclusion criteria (14 listed)
- Pregnant or breast-feeding females
- Suspicion of intolerance to duloxetine.
- History of any clinical condition that, in the Investigator's criteria, could potentially reoccur with the suggested change of therapy (sarcoma, lymphoma, etc).
- Concomitant condition that could mimic fibromialgy (lupus, endocrine diseases, muscular diseases, multiple sclerosis)
- or Acute illness within 15 days prior to the inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duloxetine 60 mg, QDAlso: XeristarDuloxetine 60 mg, 1 table/day, 1 year | Drug | A |
Primary outcome
Variation in pain measured using the Brief Pain Inventory questionnaire in both branches of the study
Time frame: Time frame: basal visit, weeks 4, 12, 24, 36 and 48
5 secondary outcomes
Assess differences in Short-Form 36 Health Survey (SF-36) questionnaire scale score.
Time frame: basal visit, weeks 12, 24 and 48
Assess differences in Beck Depression Inventory (BDI) questionnaire scale score.
Time frame: basal visit, weeks 12, 24 and 48
Assess differences in Profile of Mood States - Forma A (POMS-A) questionnaire scale score.
Time frame: basal visit, weeks 12, 24 and 48
Assess the percentage of patients that leave duloxetine due to intolerance or toxicity.
Time frame: basal visit, weeks 4, 12, 24, 36 and 48
Assess, if possible, pharmacokinetic profile of duloxetine and determine interaction with antiretroviral drugs.
Time frame: basal visit, weeks 4, 12, 24, 36 and 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Negredo Eugenia, MD,PhD principal investigator
Lluita contra la Sida Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Duloxetine 60 mg, QD in people with Fibromyalgia and HIV-1 Infection, run by Germans Trias i Pujol Hospital at 1 site in Spain.
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 5 inclusion and 14 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 4 Dec 2019. 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 Spain. 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 phase mean?
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?
Variation in pain measured using the Brief Pain Inventory questionnaire in both branches of the study (time frame: Time frame: basal visit, weeks 4, 12, 24, 36 and 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2019.