Fibromyalgia MedDRA version: 8.1 Level: LLT Classification code 10048439
Conditions
Interventions
Product Name: Pregabalin
Product Code: PD0144723 (CI-1008)
Pharmaceutical Form: Capsule*
INN or Proposed INN: Pregabalin
Other descripti
Sponsors
Pfizer Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial: 1. Patients must have met the inclusion criteria for the preceding fibromyalgia Study A0081100, and must have received pregabalin/placebo under double-blind conditions; 2. Female patients must continue to use adequate birth control methods and have a negative pregnancy test at the indicated intervals (open-label Visit 1 [Termination Visit of the double-blind protocol] and open-label Visit 3); 3. Patients must be able to follow the investigator’s instructions and be able to comply with visit requirements; and 4. Patients must have personally signed and dated a legally effective written informed consent document indicating that the patient has been informed of all pertinent aspects of the trial. 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: Patients presenting with any of the following will not be included in the trial: 1. Patients who experienced a serious adverse event during the previous fibromyalgia Study A0081100 which was determined to be related to the study medication by the investigator or the sponsor; and/or 2. Patients with white blood cell (WBC) count <2.5 × 109/L, neutrophil count <1.5 × 109/L, and platelet count <100 × 109/L on laboratory tests from Visit 5 in Study A0081100.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of pregabalin at doses up to 600 mg/day in patients who participated in the double-blind fibromyalgia Study A0081100 and who wish to receive open-label pregabalin therapy. ;Secondary Objective: ;Primary end point(s): This section is not applicable as this is an open-label study. | — |
Countries
Denmark, Germany, Ireland, Italy, Netherlands, Portugal, Sweden, United Kingdom
Outcome results
None listed