pain and associated symptoms in patients with fibromyalgia. MedDRA version: 9.1 Level: LLT Classification code 10048439 Term: Fibromyalgia
Conditions
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female of any race, at least 18 years of age; 2. Female patients must be non-pregnant and non-lactating, and be either postmenopausal, surgically sterilized, or using an appropriate method of contraception. Prior to starting the trial, it is strongly recommended that women of childbearing potential use two of the following methods of birth control for at least one month or for whatever amount of time the prescribing doctor determines it will take for the methods of birth control to be fully effective: oral birth control pills, diaphragms, progesterone implanted rods, medroxyprogesterone acetate, Depo-Provera, or condoms. Women of childbearing potential must have a confirmed negative serum pregnancy test at the Screening visit (Visit 1); 3. Patients must have personally signed and dated a legally effective written informed consent prior to admission to the study; 4. At screening (V1), patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites); 5. At screening (V1), patients must have a score of =40 mm on the Pain Visual Analog Scale (VAS); 6. Patients must be willing and able to understand and cooperate with study procedures. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with other severe pain (e.g., DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia; 2. Patients with any inflammatory musculoskeletal disorders, rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders; 3. Previous participation in a clinical trial with [S,S]-reboxetine or currently receiving treatment with Edronax® for any condition; 4. Any patients judged clinically to be at risk of suicide based on Beck’s Scale for Suicide Ideation (BSS) and clinical judgement; 5. Patients who have a history of a seizure disorder including alcoholic seizures, a family history of seizures or a history of head trauma that resulted in loss of consciousness or concussion; 6. History of uncontrolled narrow angle glaucoma; 7. History of recurrent syncope or evidence of low blood pressure (20 mmHg or diastolic blood pressure >10 mmHg on standing (from supine); 9. Patients with a history of transient ischemic attacks, stroke, or the presence of a carotid bruit (unless significant carotid stenosis (>70%) has been ruled out by appropriate investigation); 10. History of chronic hepatitis B or C, acute hepatitis A, B or C within the past 3 months, or HIV infection; 11. Patients with serious hepatic, respiratory, haematologic, renal or immunologic illnesses, or unstable cardiovascular disease; 12. Malignancy within the past 2 years with the exception of basal cell carcinoma; 13. Patients with a history of illicit drug or alcohol abuse within the last 2 years; 14. Patients with significant hepatic impairment (i.e. AST, ALT or total bilirubin > 1.5 x ULN); 15. Platelet count 40 mm/hr; 17. Abnormal antinuclear antibody (ANA ?1:160 titre), or rheumatoid factor (RF >80 IU/mL); 18. Abnormal (clinically relevant) 12 lead electrocardiogram (ECG). See ?Appendix 8 of the protocol; 19. Patients taking any other experimental drugs within 30 days prior to screening (V1), or according to local regulation if greater than 30 days; 20. Patients with active GI disease including any GI surgery that in the opinion of the investigator would interfere with the absorption of study medication; 21. Patients with difficulties swallowing tablets or unable to tolerate oral medication; 22. Use of prohibited pain/sleep medications (including antidepressants, sedatives, hypnotics, opiates, muscle relaxants) in the absence of appropriate washout periods); 23. Clinically significant or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise participation in the trial; 24. Patients with pending Worker’s Compensation, Workman’s Compensation, civil litigation or disability claims pertinent to the patient’s fibromyalgia; current involvement in out-of-court settlements for claims pertinent to the patient’s fibromyalgia; or currently receiving monetary compensation as a result of any of the above (USA only; for non-US centers-patients involved in legal cases related to fibromyalgia). 25. A current or recent diagnosis (last 6 months), or episode of major depressive disorder, dysthymia (as diagnosed by M.I.N.I) and/or uncontrolled depression; 26. History of mania, hypomania, other psychotic disor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the long-term safety and tolerability of [S,S]-reboxetine (QD) in patients with fibromyalgia;Secondary Objective: • To assess the long-term efficacy of [S,S]-reboxetine (QD) in the management of fibromyalgia. ;Primary end point(s): The following parameters will be obtained in order to determine the safety and tolerability of [S,S]-reboxetine in patients with fibromyalgia. 1. Vital signs (supine/standing blood pressure and pulse) 2. Physical examination 3. 12-lead ECG 4. Hematology/Biochemistry 5. Adverse events | — |
Countries
Belgium, Czech Republic, France, Germany, Netherlands, Sweden, United Kingdom
Outcome results
None listed