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

Pfizer bv0 sites592 target enrollmentAugust 10, 2006

Overview

No summary available.

Registry

who.int

Start Date

August 10, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Pfizer bv

•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\.