In this fibromyalgia pain study in patients taking medication for depression, neither subjects nor investigators will know treatment assignments. The study is to determine if pregabalin demonstrates improvement compared to placebo (inactive substance)in improving pain associated with fibromyalgia. Subjects will be randomly assigned by chance(like the flip of a coin) to receive either pregabalin or placebo in one treatment period and then switch to the opposite for the second treatment period.
- Conditions
- This study will be conducted in subjects with fibromyalgia. Subjects will also be on concurrent medication for comorbid depression.MedDRA version: 14.0Level: PTClassification code 10048439Term: FibromyalgiaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2011-002480-19-ES
- Lead Sponsor
- PFIZER, S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 193
1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including the training and completion of the daily pain and sleep diaries using Interactive Voice Response System (IVRS).
3. Men or women of any race or ethnicity who are at least 18 years of age.
4. Men or women must use appropriate methods of contraception. Women must be nonpregnant and nonlactating,postmenopausal, or surgically sterilized; women of childbearing potential must use appropriate methods of contraception (including barrier or hormonal method); all women must have a confirmed negative serum pregnancy test at baseline.
5. At screening (V1), subjects must meet the 1990 ACR criteria for fibromyalgia (eg, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites).
6. Documented diagnosis of depression (eg, major depressive disorder, depression not otherwise specified (NOS), or dysthymia) and on stable dose of a single approved SSRI or SNRI agent for the treatment of depression for at least 3 months (with no change in medication type). During this 3 month period, subjects must be on a stable dose of SSRI or SNRI for the final 2 months prior to randomization.
7. At screening (V1) and randomization (V2), subjects must have a score of ?4 on the Numeric Rating Scale for Pain (1-week recall period).
8. At randomization (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be ?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 275
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
1. Have failed pregabalin treatment due to lack of efficacy at therapeutic doses of ?300 mg daily, have intolerance to pregabalin or any pregabalin ingredient, or participated in a pregabalin clinical trial. If the subject has taken pregabalin and discontinued for reason other than lack of efficacy or intolerance, then they will be eligible. Pregabalin use within the last 30 days (prior to V1) is not permitted.
2. Use of prohibited pain/sleep medications, (eg, sedatives, hypnotics, NSAIDs, opiates, muscle relaxants) during the study. Washout required prior to study entry.
3. Subjects with severe depression based on either 1) a HADS score in the severe category (>/= 15), or 2) in the judgment of the investigator, would make the patient inappropriate for entry into this trial.
4. Subjects with pain due to other conditions (eg, DPN or PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia.
5. Subjects with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, untreated endocrine disorders, or somatoform disorder.
6. Subjects with any clinically unstable, cardiovascular, hematological, autoimmune, endocrine, renal, hepatic, retinal or gastrointestinal disease.
7. Any subject considered at risk of suicide or self harm based on investigator judgment and/or the details of a risk assessment.
8. Subjects with pending disability claims or currently receiving monetary compensation pertinent to the subject?s fibromyalgia or co-morbid diseases.
9. Erythrocyte sedimentation rate (ESR) >40 mm/h, abnormal antinuclear antibody (ANA ?1:160 titer), or rheumatoid factor (RF >80 IU/mL).
10. Estimated creatinine clearance (CLcr) ?60 mL/min (using Cockcroft-Gault equation).
Subjects who have an estimated CLcr ?60 mL/min by this screening method may
have their CLcr measured, at the investigator?s discretion, with a 24-hour urine collection performed at the central laboratory. If this 24-hour urine CLcr is >60 mL/min, the subject is not excluded.
11. Participation in any clinical trial within the 30 days prior to screening and/or during study participation.
12. Screening electrocardiogram (ECG) with any clinically significant abnormality.
13. Have had a malignancy other than basal cell carcinoma or carcinoma in situ of the cervix within the past 5 years.
14. Subjects with difficulties swallowing capsules or unable to tolerate oral medication.
15. Platelet count <100x109/L; white blood cell (WBC) count <2.5x109/L; neutrophil count <1.5x109/L.
16. Alcohol or substance abuse or dependence within the previous year per investigator judgment.
17. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
18. Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
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 efficacy of pregabalin compared with placebo in subjects with fibromyalgia and comorbid depression currently on a stable SSRI or SNRI primarily being used to treat the depression.;Secondary Objective: To evaluate the safety and tolerability of pregabalin in this population.;Primary end point(s): Endpoint mean pain score, based on the mean of the last 7 daily pain NRS scores from the daily pain diaries while receiving study medication in each treatment period<br>(eg, daily pain diary (0-10 numeric rating scale)).;Timepoint(s) of evaluation of this end point: Daily pain IVRS diaries will be completed continuously from week 0 to14.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Fibromyalgia Impact Questionnaire (FIQ);<br>- Patient Global Impression of Change (PGIC) at the end of Period 1 (V6);<br>- Proportions of subjects with ?30% and ?50% pain reduction based on daily pain diary;<br>- Subjective Sleep Questionnaire (daily diary; 5 questions);<br>- Hospital Anxiety and Depression Scale (HADS); and<br>- EuroQoL 5-Dimensions (EQ-5D).;Timepoint(s) of evaluation of this end point: FIQ, weeks 0, 6,14, PGIC, weeks 6, 14; daily pain diary proportions of subjects with pain reduction and Subjective Sleep Questionnaire, using the same analysis methods as specified for the primary efficacy endpoint, weeks 6 and 14, HADS, weeks -1, 0, 6, 14, EQ-5D, weeks 0, 6, 14