Phase 4
Completed N=530
A Study Comparing Duloxetine and Placebo in the Treatment of Fibromyalgia
Source: ClinicalTrials.gov NCT00673452 ↗Enrolled (actual)
530
Serious AEs
1.3%
Results posted
Jun 2010
Primary outcomePrimary: Patient's Global Impressions of Improvement (PGI-I) at Week 12 — 2.79; 3.36 units on a scale — p=<0.001
Summary
The purpose of this study is to confirm the efficacy and safety of duloxetine 60-120 mg once daily in comparison to placebo on symptom improvement in patients meeting criteria for fibromyalgia aged 18 and older. Patients will be randomized to duloxetine or placebo, however, all patients will receive duloxetine at some point in the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient's Global Impressions of Improvement (PGI-I) at Week 12 |
2.79; 3.36 | <0.001 sig |
| SECONDARY Change From Baseline in Brief Pain Inventory (BPI) (Modified Short Form) at 12 Week Endpoint |
-2.32; -1.57; -1.57; -0.96; -2.14; -1.40 | <0.001 sig |
| SECONDARY Change From Baseline in Multidimensional Fatigue Inventory (MFI) at 12 Week Endpoint |
-2.21; -1.38; -2.08; -1.35; -2.01; -1.09 | 0.005 sig |
| SECONDARY Change From Baseline in Beck Depression Inventory-II (BDI-II) at 12 Week Endpoint |
-5.53; -3.63 | 0.007 sig |
| SECONDARY Change From Baseline in Clinical Global Impressions of Severity (CGI-S) at 12 Week Endpoint |
-1.05; -0.71 | <0.001 sig |
| SECONDARY Change From Baseline in Beck Anxiety Inventory (BAI) at 12 Week Endpoint |
-3.14; -3.22 | 0.907 |
| SECONDARY Change From Baseline in 36-Item Short-form Health Survey (SF-36) at 12 Weeks |
18.48; 13.26; 9.33; 2.91; 10.05; 2.61 | 0.003 sig |
| SECONDARY Change From Baseline in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score at 12 Week Endpoint |
-4.88; -3.92 | 0.083 |
| SECONDARY Change From Baseline in the Mood, Anxiety, Pain, Sleep, and Stiffness Likert Scale at 12 Week Endpoint |
-1.27; -0.52; -1.22; -0.58; -2.45; -1.73 | <0.001 sig |
| SECONDARY Number of Responders: 30% Improvement in Brief Pain Inventory Average Pain at 12 Week Endpoint |
119; 88 | 0.002 sig |
| SECONDARY Number of Responders: 50% Improvement in Brief Pain Inventory Average Pain Score at 12 Week Endpoint |
83; 55 | 0.003 sig |
| SECONDARY Change From Baseline in Blood Pressure at 12 Week Endpoint |
1.09; -0.72; 0.83; 0.31 | 0.084 |
| SECONDARY Change From Baseline in Heart Rate at 12 Week Endpoint |
1.76; -0.20 | 0.003 sig |
| SECONDARY Number of Patients With Columbia Suicide Severity Rating Scale (CSSR-S) Events (Behaviors, Ideations, Acts) |
6; 7; 0; 0; 0; 0 | 1.00 |
| SECONDARY Change From Baseline in Weight at 12 Week Endpoint |
-0.62; 0.21 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- male or female patients
- aged 18 and older who meet criteria for fibromyalgia as defined by the American College of Rheumatology
- have a score of at least 4 on the average pain item of the Brief Pain Inventory (BPI) (modified short form) at visits 1 and 2
- all females must test negative for pregnancy at the time of enrollment
- have a degree of understanding such that the patient can provide informed consent, complete protocol required assessments and communicate intelligibly with the investigator and study coordinator.
Exclusion Criteria
- have pain symptoms related to traumatic injury, structural rheumatic disease, or regional rheumatic disease that will interfere with interpretation of outcome measures
- have regional pain syndrome, multiple surgeries or failed back syndrome
- have confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease (i.e. systemic lupus erythematosus)
Data sourced from ClinicalTrials.gov (NCT00673452). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.