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

Conditions: Treatment of fibromyalgia
MedDRA version: 8.1Level: LLTClassification code 10048439Term: Fibromyalgia

Registration Number: EUCTR2006-001840-30-IT

Lead Sponsor: PFIZER

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 592

Inclusion Criteria

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

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
Main Objective: To evaluate the safety of pregabalin at doses up to 600 mg/day in patients who participated in the double-blind fibromyalgia Study A0081100 and who wish to receive openlabel pregabalin therapy.;Secondary Objective: N.A.;Primary end point(s): This section is not applicable as this is an open-label study.

Secondary Outcome Measures