Phase 4
N=308
A Study for Adult Patients With Fibromyalgia
Fibromyalgia, Primary · Fibromyalgia, Secondary
Bottom Line
View on ClinicalTrials.gov: NCT00965081 ↗Enrolled (actual)
308
Serious AEs
0.3%
Results posted
Nov 2011
Primary outcome: Primary: Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) "24-Hour Average Pain" Item (Question 3) of the BPI-Modified Short Form Score — -2.04; -1.70 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Duloxetine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) "24-Hour Average Pain" Item (Question 3) of the BPI-Modified Short Form Score |
-2.04; -1.70 | — |
| SECONDARY Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) - Modified Short Form |
-2.23; -1.98; -1.56; -1.36; -2.25; -1.90 | — |
| SECONDARY Patient Global Impression - Improvement (PGI-I) at Endpoint |
2.97; 3.35 | — |
| SECONDARY Clinical Global Impression of Improvement (CGI-I) for Depression at Endpoint |
3.34; 3.51 | — |
| SECONDARY Change From Baseline to 12-Week Endpoint Beck Depression Inventory-II (BDI-II) |
-5.47; -3.91 | — |
| SECONDARY Change From Baseline to 12-Week Endpoint Fibromyalgia Impact Questionnaire (FIQ) |
-14.62; -9.75 | — |
| SECONDARY Change From Baseline to 12-Week Endpoint Beck Anxiety Inventory (BAI) |
-3.76; -3.31 | — |
| SECONDARY Change From Baseline to 12-Week Endpoint 36-Item Short-Form Health Survey (SF-36) |
17.06; 14.01; 7.88; 6.12; 9.36; 5.55 | — |
| SECONDARY Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia -Suicide Severity Rating Scale (C-SSRS) |
3; 3; 1; 0; 1; 0 | — |
Summary
The main purpose of this study is to determine if 30 milligrams (mg) of duloxetine is effective in the treatment of fibromyalgia compared to placebo.
Eligibility Criteria
Inclusion Criteria
- Meet study criteria for fibromyalgia diagnosis.
Exclusion Criteria
- Have previously or are currently taking duloxetine.
- Have been diagnosed with certain psychoses, bipolar or schizoaffective disorder
- Have pain symptoms that are difficult to differentiate from fibromyalgia.
- Have seizure disorder, uncontrolled narrow angle glaucoma, or acute liver injury (such as hepatitis) or severe cirrhosis.
- Have had any primary Axis 1 diagnosis other than major depressive disorder or generalized anxiety disorder within the past year.
- Are pregnant or breast-feeding
- Have a current or previous diagnosis of rheumatoid, infectious or inflammatory arthritis or an autoimmune disease
- Have a regional pain syndrome, failed back syndrome or chronic localized pan related to any past surgery
- Have a serious unstable medical illness
- Have a history of substance abuse or dependence within the past year
Data sourced from ClinicalTrials.gov (NCT00965081). 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.