Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Six-Month, Double-Blind, Placebo Controlled, Durability of Effect Study of Pregabalin for Pain Associated With Fibromyalgia
Brief Summary: The purpose of this research study of pregabalin and fibromyalgia is to see if 1. pregabalin reduces the pain of fibromyalgia and if this effect lasts for six months and 2. to see if different dosages work better (reduce pain and mild to no side effects) for different people.


Options:
A: Inclusion Criteria:

* Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081100, and must have received pregabalin/placebo under double-blind conditions.

Exclusion Criteria:

* Patients may not participate in the study if they 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.
B: Inclusion Criteria:

* Subjects must meet diagnostic criteria for fibromyalgia;
* Subjects must report difficulty in maintaining sleep at least 3 times per week and meet Research Diagnostic Criteria (RDC) for insomnia disorder, corroborated by subject diary, and meet PSG inclusion criteria at visit 3.

Exclusion Criteria:

* History of active sleep disorder other than Research Diagnostic Criteria(RDC) insomnia criteria or any sleep or circadian rhythm disturbance;
* Use of medications known to affect sleep wake function by Visit 2;
* Involved in night or rotating shift work, or travel across \>4 time zones 14 days prior to screening and during study; regular daytime napping
* PSG finding of apnea/hypopnea or periodic limb movement with arousal index \>10/hr on either night of PSG.
C: Inclusion Criteria:

* diagnosis of fibromyalgia by ACR criteria
* ambulatory patients
* complete of 5 pain diaries during 1 week evaluation
* other inclusion criteria may apply

Exclusion Criteria:

* pregnant or of childbearing potential not using contraceptives
* use of pregabalin in the past
* concomitant use of opioids or gabapentin
* estimated creatinine clearance less than 60
* other criteria may apply
D: Inclusion Criteria:

* At screening (V1), patients must meet the American College of Rheumatology criteria for fibromyalgia (i.e. widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites
* At Screen (V1) and enrollment (V2), patients must have a score of greater than 40 mm on the Pain Visual Analog Scale

Exclusion Criteria:

* Other severe pain or inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections or untreated endocrine disorders; or severe depression and other serious hepatic, respiratory, hematologic or immunologic illness or active malignancy or history of malignancy (examples of prohibited diseases: Hepatitis C, HIV, diabetes with nerve pain, other nerve pain (shingles), sleep apnea, epilepsy, narcolepsy, rheumatoid arthritis, generalized osteoarthritis, Lupus, Lyme disease unless sign and symptom free for 2 years, Sjogren's Syndrome, Sarcoid, Psoriatic Arthritis, Scleroderma)
* Previous participation in a clinical trial with pregabalin; currently receiving or pending disability claims or workmans compensation or civil litigation, or used other experimental medicines within 30 days of screening
* Creatinine Clearance less than 60 mL/min (estimated from serum creatinine; low platelet and/or white blood cell counts; abnormal Westergren erythrocyte sedimentation rate; abnormal antinuclear antibody (ANA greater than 3U), or rheumatoid factor (RF greater than 80 IU/mL); abnormal (clinically relevant 12 lead ECG)
* Use of prohibited pain/sleep medications (including antidepressants, sedatives, hypnotics, NSAIDs, opiates, muscle relaxants) during the study. Washout required prior to study entry.

Answer: D