Fibromyalgia MedDRA version: 8.1 Level: LLT Classification code 10048439
Conditions
Interventions
Trade Name: Lyrica
Product Name: Pregabalin
Product Code: PD 0144723 (CI-1008)
Pharmaceutical Form: Capsule*
INN or Proposed INN: Pregabalin
Other descriptive name: ((S)-3-(aminomethyl)-5- methylhexan
Sponsors
Pfizer Inc./ Ann Arbor
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 60 mL/min, patient is eligible for the study. 11. Platelet count 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is: · To evaluate the efficacy and safety of pregabalin (BID) compared with placebo for the symptomatic relief of pain in patients with fibromyalgia. If the first objective is met, then the second primary objective will be: · To evaluate the efficacy and safety of pregabalin (BID) compared with placebo for the symptomatic relief of pain and improvement of global impressions in patients with fibromyalgia. ;Secondary Objective: To evaluate the efficacy of pregabalin (BID) compared with placebo for improvement in sleep, function, fatigue, health-related quality of life, and mood disturbance associated with fibromyalgia. ;Primary end point(s): The primary endpoint for the first objective is: 1. Endpoint mean pain score, defined as the mean of the last 7 pain diary entries in the study while the patient is on study medication. If the first objective is positive (efficacy in endpoint mean pain), 1 additional endpoint will be assessed for the second objective: 2. Patient Global Assessment (Patient Global Impression of Change) at Termination Visit. | — |
Countries
Denmark, Germany, Ireland, Italy, Netherlands, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed