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Pilot, Opened, Randomized Clinical Trial to Assess the Efficacy of Duloxetine in the Treatment of Fibromialgy in Patients With Infection by HIV 1+

CompletedPhase 3NCT00552682
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

The purpose of this study is to compare duloxetine with conventional treatment of pain in HIV-1 infected patients.

Study details

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+
Conditions
Interventions
  • Drug: Duloxetine 60 mg, QD
Sponsor
Germans Trias i Pujol Hospital
Collaborators
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Start date
2007-01
Primary completion
2009-07
Sex
All
Age range
from 18 Years to 70 Years
Results posted
No results posted in this snapshot
Countries
Spain
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Patients aged 18 years old and more. Age +18 years old. 2. Documented HIV-1-infection. 3. Former diagnosis of fibromialgy. 4. History of good compliance with visit schedule and medication intake. 5. Patients voluntary signed the informed consent. Exclusion Criteria: 1. Pregnant or breast-feeding females 2. Suspicion of intolerance to duloxetine. 3. History of any clinical condition that, in the Investigator's criteria, could potentially reoccur with the suggested change of therapy (sarcoma, lymphoma, etc). 4. Concomitant condition that could mimic fibromialgy (lupus, endocrine diseases, muscular diseases, multiple sclerosis) 5. or Acute illness within 15 days prior to the inclusion 6. 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) 7. Anorexia or nervous bulimia 8. History or suspected drug or alcohol abuse. 9. Glaucoma 10. History of heart disease including cardiac arrhythmias 11. Severe obesity (body mass index \> 45). 12. Concomitant medication with IMAOS, cimetidine or quinolonas 13. Patients with hepatic or renal serious failure (Creatinin clearance \<30 ml/min) 14. Patients with Hypericum perforatum as a concomitant treatment.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00552682