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

Pfizer Ltd0 个研究点目标入组 592 人开始时间: 2006年6月11日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•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

•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.

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