Fibromyalgia Musculoskeletal Diseases Other soft tissue disorders, not elsewhere classified
Conditions
Interventions
1. Pregabalin-duloxetion combination
2. Pregabalin
3. Duloxetine
4. Inert placebo
As per a double-dummy, balanced Latin Square design, trial treatments are administered orally in four different treat
Sponsors
Queen's University (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Fibromyalgia according to American College of Rheumatology (ACR) criteria 1990 2. Experiencing daily moderate pain (greater than or equal to 4/10) for at least 3 months 3. Adults aged 18 to 70 years, either sex 4. Patients entering the study on duloxetine, gabapentinoids and other drugs which adversely interact with study drugs (e.g., selective serotonin receptor inhibitors [SSRIs], momanime oxidase inhibitors [MAOIs], tramadol etc.) must be weaned off. Participants taking less than 200 mg morphine equivalents/day are allowed to continue these medications at a steady dose. 5. Permitted analgesic medications are non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen (4 g/d) and aspirin (less than or equal to 325 mg/d for cardiac prophylaxis) 6. Serum laboratory results obtained at study entry: 6.1. Liver function tests: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than 1.2 times upper limit of normal 6.2. Creatinine clearance less than 1.5 times upper limit of normal 6.3. Negative serum betaHCG for women of childbearing potential 7. Adequate birth control for all women of child-bearing potential 8. Sufficient cognitive function and English language skills to complete questionnaires and communicate verbally with the nursing staff to permit titration of the study drugs
Exclusion criteria
Exclusion criteria: 1. Presence of a painful condition, including inflammatory rheumatic disease, as severe as (or worse than), but distinct from, their fibromyalgia 2. Pregnancy or lactation 3. Women of child-bearing potential not using adequate contraceptives 4. End-stage kidney or liver disease 5. Unstable cardiovascular disease (myocardial infarction [MI] within preceding year, unstable angina or congestive heart failure) or clinically relevant abnormal 12-lead electrocardiogram 6. Signs or symptoms of any central neurologic disorder (including seizures) 7. Untreated endocrine disorder 8. A severe mood disorder as diagnosed by a psychiatrist and/or active suicidal ideation 9. Hypersensitivity to any of the study medications 10. History of significant abuse of illicit drugs, prescription drugs or alcohol as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV R) 11. Patients requiring continued treatment with drugs which adversely interact with study medication (e.g. quinolone antibiotics, warfarin, SSRIs etc.) 12. Patients taking more than 200 mg morphine equivalents/day 13. Uncontrolled diabetes mellitus 14. Uncontrolled hypertension 15. Documented human immunodeficiency virus (HIV), hepatitis and other clinically relevant liver dysfunction 16. Malignant diseases (including brain tumours) 17. Subjects under other investigational studies 18. Hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrose isomaltase insufficiency 19. Uncontrolled narrow-angle glaucoma 20. Continued use of MAOIs, fluvoxamine, selective serotonin reuptake inhibitors (SSRIs) and anticoagulants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Daily pain intensity, recorded at study baseline and during each treatment at maximal tolerated dose (MTD) | — |
Secondary
| Measure | Time frame |
|---|---|
| Recorded at baseline and during each treatment at maximal tolerated dose (MTD): 1. Fibromyalgia Impact Questionnaire 2. Number of tender points 3. Medical Outcomes Study Sleep Scale 4. Global pain relief 5. Brief Pain Inventory 6. Beck Depression Inventory 2 7. Beck Anxiety Inventory 8. Short form McGill Pain Questionnaire 9. 36-item short form (SF-36) quality of life survey 10. Maximal tolerated doses of of duloxetine and pregabalin 11. Frequency/severity of other treatment-emergent adverse effects 12. Blinding questionnaires 13. Acetaminophen consumption | — |
Countries
Canada
Outcome results
None listed