A 12-WEEK, OPEN-LABEL, SAFETY TRIAL OF PREGABALIN IN PATIENTSWITH FIBROMYALGIA - N/A

Pfizer Ltd/Ann Arbor0 sites592 target enrollmentAugust 7, 2006

Overview

No summary available.

Registry

who.int

Start Date

August 7, 2006

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Pfizer Ltd/Ann Arbor

•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

•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\.