A 12-WEEK, OPEN-LABEL, SAFETY TRIAL OF PREGABALIN IN PATIENTS WITH FIBROMYALGIA - ND

PFIZER0 sites592 target enrollmentDecember 6, 2006

Overview

No summary available.

Registry

who.int

Start Date

December 6, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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\.