Esreboxetine is being developed for the treatment of fibromyalgia. MedDRA version: 9.1 Level: LLT Classification code 10048439 Term: Fibromyalgia
Conditions
Interventions
Product Name: esreboxetine succinate
Product Code: PNU-165442G
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: esreboxetine
CAS Number: 98769-81-4
Current Sponsor code: PN-165442 / P
Sponsors
Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ UK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet the following criteria to be eligible to participate in the study. These criteria are mandatory and must be met to provide evaluable data. 1. Male or female of any race, at least 18 years of age; 2. Female subjects must be non-pregnant and non-lactating, and be either postmenopausal (at least 1 year following the last menstrual period), surgically sterilized, or using an appropriate method of contraception. Prior to starting the study, 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, or condoms. Women of childbearing potential must have a confirmed negative serum pregnancy test at the Screening visit (V1); 3. Subjects must have personally signed and dated a legally effective written informed consent prior to admission to the study; 4. At screening (V1), subjects must meet the American College of Rheumatology (ACR) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in atleast 11 of 18 specific tender point sites); 5. At screening (V1), subjects must have a score greater than or equal to 40 mm on the pain Visual Analogue Scale; 6. At randomization (V2/R), at least 4 daily pain diaries must be completed satisfactorily within the last 7 days and the mean daily pain score must be greater than or equal to 4.0 points; 7. At randomization (V2/R), subjects must have a FIQ-Total score greater than or equal to 45 points; 8. Subjects 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: Subjects may not participate in the study if they meet any of the following criteria: 1. Subjects with other severe pain (eg, DPN and PHN) that may confound assessment or self evaluation of the pain associated with fibromyalgia; 2. Subjects with any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), clinically significant active infection, or untreated endocrine disorder; 3. Previous exposure or participation in a clinical study with ESRBX or currently receiving treatment with Edronax® for any condition; 4. Subjects 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; 5. History of uncontrolled narrow angle glaucoma; 6. History of urinary retention; 7. Abnormal (clinically relevant) 12-lead electrocardiogram (see section Appendix 14); 8. History of recurrent syncope or evidence of low blood pressure (20 mmHg or diastolic blood pressure >10 mmHg on standing (from supine); 10. Subjects with uncontrolled hypertension; 11. Subjects 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); 12. History of chronic hepatitis B or C, acute hepatitis A, B or C within the past 3 months, or HIV infection; 13. Malignancy within the past 2 years with the exception of basal cell carcinoma; 14. Subjects with a history of illicit drug or alcohol abuse within the last 2 years; 15. Subjects with significant hepatic impairment (ie, confirmed AST, ALT or Total Bilirubin >1.5 x ULN); 16. Platelet count 40 mm/hr; 18. Abnormal antinuclear antibody (ANA =1:160 titre), or rheumatoid factor (RF >80 IU/mL); 19. Subjects taking any other experimental drugs within 30 days prior to screening (V1), or according to local regulation if greater than 30 days; 20. Subjects with active GI disease including any GI surgery that in the opinion of the investigator would interfere with the absorption of study medication; 21. Subjects with difficulties swallowing tablets or unable to tolerate oral medication; 22. Use of prohibited pain/sleep medications (including antidepressants, sedatives, longacting hypnotics, opiates, muscle relaxants; see Table 2, Section 5.5.1) in the absence of appropriate washout periods; 23. Subjects 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-subjects involved in legal cases related to fibromyalgia); 24. 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; 25. History of mania, hypomania, other psychotic disorder, or current mood disorder with psychotic features, as diagnosed by M.I.N.I; 26. Any subjects judged by a mental healthcare professional (a psychiatrist or licensed PhD level clinical psychologist) to be at risk o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of ESRBX (QD) compared with placebo treatment in assessing the maintenance of effect for the treatment of pain intensity and function associated with fibromyalgia.;Secondary Objective: To evaluate the efficacy of ESRBX (QD) compared with placebo treatment on pain intensity and global assessment of overall fibromyalgia status, functional status, global assessment scores, sleep and fatigue associated with fibromyalgia; To evaluate the long-term safety and tolerability of ESRBX compared with placebo for the treatment of fibromyalgia.;Primary end point(s): Change from baseline to V10 and V13/T in the mean daily pain rating score measured by the 11-point pain intensity Numerical Rating Scale (NRS) where scores range from 0-10; baseline is defined as the mean daily pain rating score at randomization (V2/R); Change from baseline to V10 and V13/T in the FIQ-Total score where scores range from 0-100; baseline is defined as the FIQ-Total score at V2/R. | — |
Countries
Netherlands
Outcome results
None listed