Combination drug therapy for fibromyalgia pain
| ISRCTN | ISRCTN20173707 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20173707 |
| Secondary identifying numbers | ANAE-172-01 |
- Submission date
- 12/01/2011
- Registration date
- 28/02/2011
- Last edited
- 14/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ian Gilron
Scientific
Scientific
Department of Anesthesiology
Victory 2 Pavillion
Kingston General Hospital
76 Stuart Street
Kingston
K7L2V7
Canada
Study information
| Study design | Double-blind randomised placebo-controlled four-period crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Combination pharmacotherapy for the management of pain in fibromyalgia: a double-blind, randomised, placebo-controlled, four-period crossover trial |
| Study objectives | A combination of duloxetine and pregabalin has a superior therapeutic profile than that of either drug alone for reducing fibromyalgia pain. |
| Ethics approval(s) | Queen's University Research Ethics Board, 09/11/2010 |
| Health condition(s) or problem(s) studied | Fibromyalgia |
| Intervention | 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 treatment periods. In each of the four periods, doses of study medication are gradually titrated - over 24 days - towards each individual maximal tolerated dose and continued at that dose for seven days followed by an 11 day taper-washout period. Ceiling doses are 450 mg daily for pregabalin and 120 mg daily for duloxetine. Total duration of follow-up is 9 months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Duloxetine, pregabalin |
| Primary outcome measure | Daily pain intensity, recorded at study baseline and during each treatment at maximal tolerated dose (MTD) |
| Secondary outcome measures | 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 |
| Overall study start date | 01/02/2011 |
| Completion date | 30/01/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 69 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/02/2011 |
| Date of final enrolment | 30/01/2014 |
Locations
Countries of recruitment
- Canada
Study participating centre
Kingston General Hospital
Kingston
K7L2V7
Canada
K7L2V7
Canada
Sponsor information
Queen's University (Canada)
University/education
University/education
Department of Anesthesiology
99 University Avenue
Kingston
K7L 3N6
Canada
| Website | http://www.queensu.ca/ |
|---|---|
"ROR" |
https://ror.org/02y72wh86 |
Funders
Funder type
Government
Canadian Institutes of Health Research
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
- Location
- Canada
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2016 | Yes | No |
Editorial Notes
14/03/2017: Publication reference added.
