Phase 3
N=393
A Study of Duloxetine in Fibromyalgia
Fibromyalgia
Bottom Line
View on ClinicalTrials.gov: NCT01552057 ↗Enrolled (actual)
393
Serious AEs
0.5%
Results posted
Dec 2014
Primary outcome: Primary: Change From Baseline to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM) — -1.90; -1.58 units on a scale — p=0.0988
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Duloxetine 60 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM) |
-1.90; -1.58 | 0.0988 |
| PRIMARY Change From Baseline to 2 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM) |
-1.00; -0.60 | 0.0113 sig |
| PRIMARY Change From Baseline to 4 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM) |
-1.55; -0.94 | 0.0005 sig |
| PRIMARY Change From Baseline to 6 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM) |
-1.81; -1.09 | <0.0001 sig |
| PRIMARY Change From Baseline to 10 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM) |
-1.85; -1.41 | 0.0226 sig |
| PRIMARY Change From Baseline up to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (ANCOVA) |
-1.60; -1.22 | 0.0408 sig |
| SECONDARY Patients Global Impression of Improvement (PGI-I) at Endpoint |
2.83; 3.32 | 0.0003 sig |
| SECONDARY Clinical Global Impression of Improvement (CGI-I) at Endpoint |
2.83; 3.27 | 0.0012 sig |
| SECONDARY Change From Baseline to 14-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ) |
-18.41; -13.05 | 0.0073 sig |
| SECONDARY Change From Baseline to 14-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores |
7.40; 3.06; 8.20; 0.44; 10.95; 5.28 | 0.0049 sig |
| SECONDARY Change From Baseline to 14-Week Endpoint in Beck Depression Inventory-II (BDI-II) |
-4.07; -1.22 | 0.0002 sig |
| SECONDARY Change From Baseline to 14-Week Endpoint in Widespread Pain Index (WPI) and Symptom Severity (SS) in American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria 2010 |
-2.34; -1.06; -1.37; -1.00 | 0.0029 sig |
| SECONDARY Change From Baseline to 14-Week Endpoint in Average Pain and Worst Pain Severity Score Within 24-Hours in Participant Diary |
-1.82; -1.48; -1.81; -1.34 | 0.0755 |
| SECONDARY Change From Baseline to 14-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form |
-1.91; -1.35; -1.72; -1.23; -1.77; -1.20 | 0.0126 sig |
Summary
The purpose of the study is to assess the effectiveness and safety of duloxetine in participants with fibromyalgia.
Eligibility Criteria
Inclusion Criteria
- Participants fulfilling the following criteria in the American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia
- Participants with pain rated severity 4 or over by Brief Pain Inventory (BPI) - average pain severity item (Question 3)
Exclusion Criteria
- Participants with serious cardiovascular, hepatic, renal, respiratory, or hematological disease, or clinically significant laboratory or electrocardiogram abnormality which indicate a serious medical problem or require significant intervention in the judgment of the investigators
- Participants with alanine aminotransferase/aspartate aminotransferase of not less than 100 international units per liter (IU/L) or total bilirubin of not less than 1.6 milligrams per deciliter (mg/dL)
- Participants with serum creatinine level of not less than 2.0 mg/dL, participant who has undergone kidney transplantation or hemodialysis
- Participants with pain difficult to discriminate from pain associated with fibromyalgia or disease which disturbs the assessment
- Participants with treatment-refractory fibromyalgia
- Participants with thyroidal dysfunction, excluding those assessed by the investigator that the disorder is controlled as appropriate by 3-month or longer drug therapy
- Participants with present or past history of rheumatoid arthritis, inflammatory arthritis, infectious arthritis, or auto immune disease rather than thyroid deficiency
- Participants with an axis I condition according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV), currently or within the past year, except for major depressive disorders
- Participants with a lifetime diagnosis of bipolar disorder or schizoaffective disorder; or any other disorder with psychotic symptoms - based on the clinical opinion of the investigator
- Participants with personality disorder or mental retardation
- Participants with uncontrolled angle closure glaucoma
- Participants with present or past history of uncontrolled seizures or convulsion disorders
- Participants with suicidal ideation within past 6 months, with suicidal attempt within past 1 year
- Participants answering "yes" to any of the questions about active suicidal ideation/intent/behaviors occurring within the past 6 months (Columbia Suicide Severity Rating Scale, Suicide Ideation section - Questions 4 and 5; Suicidal Behavior section)
- Participants with past history of multiple episodes of drug allergy
- Female participants who are pregnant, lactating, or who want to get pregnant during the study period. Male participants who want his partner to get pregnant
- Females of child-bearing potential who can't agree to utilize medically. acceptable and reliable means of birth control during the study and for 1 month following the last dose of the study
- Participants with a history of alcohol or any psychoactive substance abuse or dependence (including alcohol, but excluding nicotine and caffeine) within the past 1 year
- Participants who have a positive urine drug screen for any substance of abuse (phencyclidine, cocaine, antihypnotic agent, or cannabis)
- Participants previously treated with duloxetine
Data sourced from ClinicalTrials.gov (NCT01552057). 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.