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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 592

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials