A Study For Pregabalin In Patients With Fibromyalgia
A 14-week, Randomized, Double-blind Placebo-controlled Study For Pregabalin In Subjects With Fibromyalgia
1 other identifier
interventional
343
1 country
22
Brief Summary
The purpose of this study is to evaluate the efficacy and tolerability of pregabalin compared with placebo for management of fibromyalgia in adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2012
Longer than P75 for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2011
CompletedFirst Posted
Study publicly available on registry
July 4, 2011
CompletedStudy Start
First participant enrolled
February 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2016
CompletedResults Posted
Study results publicly available
July 30, 2018
CompletedJanuary 28, 2021
September 1, 2017
4.7 years
June 30, 2011
October 10, 2017
January 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Endpoint Mean Pain Score During the Double-blind Treatment Period at Week 14
Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. The endpoint mean pain score was defined as the mean of the Week 14 pain diary entries in the double-blind treatment phase. Baseline was defined as the mean of last 7 pain diary entries up to and including Day 1.
Baseline, Week 14
Secondary Outcomes (23)
Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14
Week 14
Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at Week 14
Baseline, Week 14
Percentage of Participants With at Least 30% Reduction in Weekly Mean Pain Score From Baseline to Week 14
Baseline, Week 14
Percentage of Participants With at Least 50% Reduction in Weekly Mean Pain Score From Baseline to Week 14
Baseline, Week 14
Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Disturbance Subscale Score
Baseline, Week 14
- +18 more secondary outcomes
Study Arms (2)
Pregabalin
EXPERIMENTALPlacebo
PLACEBO COMPARATORMatched placebo
Interventions
Eligibility Criteria
You may qualify if:
- Male or female patients, at least 18 years of age
- Meeting the ACR (America College of Rheumatology) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
- At screening (V1) and randomization (V2), patients must have a score of no less than 40 mm on the Pain Visual Analog Scale (VAS)
- At randomization (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be no less than 4
You may not qualify if:
- Patients with no less than 30% decrease on the Pain Visual Analog Scale (VAS) at randomization (V2) as compared to screening (V1)
- 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
- Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders
- CLcr less than 60 mL/min (estimated from serum creatinine)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Department of Rheumatism And Immunity, The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233000, China
Anhui Province Hospital
Hefei, Anhui, 230001, China
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, 100020, China
Southwest Hospital of the Third Military Medical University,PLA
Chongqing, Chongqing Municipality, 400038, China
Department of Neurology,General Hospital of Guangzhou Military Command of PLA
Guangzhou, Guangdong, 510010, China
Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
Department of Neurology,The First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
The Third Affiliated Hospital Of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
Rheumatology Department, The first Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
Rheumatology Department, The second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086, China
Xiangya Hospital of Centre-south University
Changsha, Kaifu District, Hunan, 410008, China
The Second Affiliated Hospital to Nanchang University
Nanchang, Jiangxi, 330006, China
Zhongshan Hospital Fudan University, Rheumatology Department
Shanghai, Shanghai Municipality, 200032, China
Xijing Hospital, The Fourth Military Medical University
Xi’an, Shanxi, 710032, China
Si Chuan Huaxi Hospital/Rheumatology Department
Chengdu, Sichuan, 610041, China
The First Affiliated Hospital of Kunming Medical University/ Rheumatology and Immunology Department
Kunming, Yunnan, 650032, China
The First Affiliated Hospital of Wenzhou Medical University/Neurology Department
Wenzhou, Zhejiang, 325000, China
China-Japan Friendship Hospital/Rheumatology Department
Beijing, 100029, China
Peking Union Medical College Hospital/Rheumatology Department
Beijing, 100032, China
PLA. The Military General Hospital of Beijing
Beijing, 100700, China
Rheumatology and Immunology Dept., Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, 200001, China
Rheumatology and Immunology Department, Shanghai Changzheng Hospital
Shanghai, 200003, China
Related Publications (1)
Zhang X, Xu H, Zhang Z, Li Y, Pauer L, Liao S, Zhang F. Efficacy and Safety of Pregabalin for Fibromyalgia in a Population of Chinese Subjects. J Pain Res. 2021 Feb 25;14:537-548. doi: 10.2147/JPR.S281483. eCollection 2021.
PMID: 33658841DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2011
First Posted
July 4, 2011
Study Start
February 6, 2012
Primary Completion
October 31, 2016
Study Completion
October 31, 2016
Last Updated
January 28, 2021
Results First Posted
July 30, 2018
Record last verified: 2017-09