A 14 WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF PREGABALIN TWICE DAILY IN PATIENTS WITH FIBROMYALGIA

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 740

Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
1. Male or female of any race, at least 18 years of age;
2. Female patients must be nonpregnant and nonlactating; additionally they must be postmenopausal, surgically sterilized, or using an appropriate method of contraception. All women must have a confirmed negative serum pregnancy test at screening (V1) prior to the randomization visit;
3. Patients must be willing and able to understand and cooperate with study procedures;
4. Patients must have personally signed and dated a legally effective written informed consent prior to admission to the study;
5. At screening (V1), patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites);
6. At screening (V1) and randomization (V2), patients must have a score of > or = 40 mm on the Pain Visual Analog Scale (VAS);
7. At randomization (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be > or = 4.

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 with > or = 30% decrease on the Pain Visual Analog Scale (VAS) at randomization (V2) as compared to screening (V1);
2. Patients with other severe pain due to other conditions (eg, DPN or PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia;
3. Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders;
4. Previous participation in a clinical trial with pregabalin, previous exposure to pregabalin or currently on pregabalin for any condition;
5. Patients with severe depression that in the judgment of the investigator, would make the patient inappropriate for entry into this trial;
6. Patients with serious hepatic, respiratory, neurologic (epilepsy, multiple sclerosis), hematologic or immunologic illnesses, an unstable cardiovascular disease, or any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results in the judgment of the investigator;
7. Patients with active malignancy of any type or a history of a malignancy (with the exception of patients with malignancy surgically removed with no evidence of recurrence within 5 years before enrollment and patients with a history of treated basal cell carcinoma);
8. Patients who are immunocompromised;
9. Patients with a history of illicit drug or alcohol abuse within the last 2 years
10. CLcr < or = 60 mL/min (estimated from serum creatinine). Patients whose CLcr estimated from serum creatinine is < or = 60 mL/min may submit a 24-hour urine sample for analysis by central laboratory. If the CLcr value based on 24-hour CLcr test is >60 mL/min, patient is eligible for the study.
11. Platelet count <100 x 109/L; white blood cell (WBC) count <2.5 x 109/L; neutrophil count <1.5 x 109/L;
12. Erythrocyte sedimentation rate (ESR) >40 mm/h;
13. Abnormal antinuclear antibody (ANA > or = 3 U), or rheumatoid factor (RF >80 IU/mL);
14. Abnormal (clinically relevant) 12 lead electrocardiogram (ECG);
15. Patients taking any other experimental drugs within 30 days prior to screening (V1);
16. Patients with active GI disease including any GI surgery that in the opinion of the investigator would interfere with the absorption of study medication;
17. Patients with difficulties swallowing capsules or unable to tolerate oral medication;
18. Use of prohibited pain/sleep medications (including antidepressants, sedatives, hypnotics, NSAIDs, opiates, muscle relaxants) in the absence of appropriate washout periods
19. Patients with pending disability claims or currently receiving monetary compensation pertinent to the patient’s fibromyalgia or co-morbid diseases.

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

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