Duloxetine 60/120 mg Versus Placebo in the Treatment of Fibromyalgia Syndrome
- Conditions
- fibromyalgia syndrome
- Registration Number
- EUCTR2005-001524-37-GB
- Lead Sponsor
- Eli Lilly and Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 320
[1]Are outpatients >18 years of age.
[2]Meet criteria for primary FMS as defined by the ACR: widespread aching pain in all four quadrants of the body and axial skeleton for >3 months duration and ³11 of 18 tender points under digital palpitation examination with an approximate force of 4 kg/cm2.
[3]Have a score of >4 on the average pain item of the Brief Pain Inventory (BPI-Modified Short Form) at Visit 1 and Visit 2.
[4]Test (all females) negative for pregnancy at Visit 1. Females of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopause) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for 1 month following the last dose of the study. Examples of reliable methods include use of oral contraceptives or Depo-Provera® Contraceptive Injection (sterile medroxyprogesterone acetate suspension, Pharmacia & Upjohn), abstinence, partner with vasectomy, diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices.
[5]Have an educational level and degree of understanding such that the patient can communicate intelligibly with the investigator and study coordinator.
[6]Judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures required by the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
[7]Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family” is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
[8]Are employed by Lilly or Boehringer Ingelheim (BI) (that is, employees, temporary contract workers, or designees responsible for the conduct of the study). Immediate family of Lilly or BI employees may participate in Lilly/BI-sponsored clinical trials, but are not permitted to participate at a sponsor facility. Immediate family” is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
[9]Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry (Visit 1).
[10]Have previously completed or withdrawn from this study or any other study investigating duloxetine. (Note: Patients who have been previously screened for a duloxetine study other than this study and never received study drug will be eligible for this study if they meet all current entry criteria.)
[11]Have any current primary Axis I diagnosis other than major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), including a current diagnosis of dysthymia (as assessed by the Mini International Neuropsychiatric Interview [MINI] or diagnosed within the past year).
[12]Have any current or previous DSM-IV Axis I diagnosis of psychosis, bipolar disorder, or schizoaffective disorder.
[13]Have any primary DSM-IV Axis I diagnosis of anxiety disorder within the past year (including panic disorder, agoraphobia without a history of panic disorder, obsessive-compulsive disorder [OCD], posttraumatic stress disorder [PTSD], generalized anxiety disorder [GAD], and social phobia). Note: Patients with specific phobias may participate in the study.
[14]Have any DSM-IV Axis II disorder, which, in the judgment of the investigator, would interfere with compliance with the study protocol.
[15]Are judged prior to randomization to be at suicidal risk by the clinical investigator or as defined by a score of 2 or greater on question 9 of the Beck Depression Inventory-II (BDI-II; Beck et al. 1988).
[18]Are women who are pregnant or breast-feeding.
[24]Have serious or unstable cardiovascular, hepatic, renal, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition (including unstable hypertension and not clinically euthyroid) or psychiatric conditions that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
[25]Have uncontrolled seizures.
[27]Have at Visit 1, alanine aminotransferase (ALT) >1.5 times the upper limit of normal (ULN), based on performing laboratory reference ranges.
[28]Have had treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit 2 or need to take within 5 days after discontinuing the study.
[31]Have uncontrolled narrow angle glaucoma.
[33]Have known hypersensitivity to duloxetine or any of the ina
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method