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A Study For Pregabalin In Patients With Fibromyalgia

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by Pfizer
Information provided by (Responsible Party):
Pfizer Identifier:
First received: June 30, 2011
Last updated: January 13, 2017
Last verified: December 2016
The purpose of this study is to evaluate the efficacy and tolerability of pregabalin compared with placebo for management of fibromyalgia in adults.

Condition Intervention Phase
Drug: pregabalin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 14-week, Randomized, Double-blind Placebo-controlled Study For Pregabalin In Subjects With Fibromyalgia

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Relief of pain associated with fibromyalgia by comparing with the baseline, the difference for endpoint mean pain score ( the mean of the last 7 pain diary entries) in the double-blind treatment period between pregabalin and placebo groups [ Time Frame: 14-week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability measures include evaluating the nature, frequency and intensity of adverse events and subject discontinuations. The Suicidality assessment (STS) is also included. [ Time Frame: 14-week ] [ Designated as safety issue: Yes ]
  • Secondary efficacy endpoints include sleep, fatigue, health-related quality of life, functioning, pain, and mood disturbance will be assessed using MOS-S, Daily Sleep Diary and Subjective Sleep Questionnaire(SSQ), MAF, SF-36, VAS, HADS. [ Time Frame: 14-week ] [ Designated as safety issue: No ]

Estimated Enrollment: 343
Study Start Date: February 2012
Estimated Study Completion Date: January 2017
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregabalin Drug: pregabalin
Pregabalin capsule, 300-450mg/day, twice daily
Placebo Comparator: Placebo
Matched placebo
Drug: placebo
Placebo, twice daily


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01387607

Contact: Pfizer Call Center 1-800-718-1021

China, Anhui
Department of Rheumatism And Immunity, The First Affiliated Hospital of Bengbu Medical College Recruiting
Bengbu, Anhui, China, 233000
Anhui Province Hospital Recruiting
Hefei, Anhui, China, 230001
China, Beijing
Beijing Chao-Yang Hospital, Capital Medical University Active, not recruiting
Beijing, Beijing, China, 100020
China, Chongqing
Southwest Hospital of the Third Military Medical University,PLA Active, not recruiting
Chongqing, Chongqing, China, 400038
China, Guangdong
Department of Neurology,General Hospital of Guangzhou Military Command of PLA Recruiting
Guangzhou, Guangdong, China, 510010
Guangdong General Hospital Active, not recruiting
Guangzhou, Guangdong, China, 510080
Department of Neurology,The First Affiliated Hospital Of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510120
China, Heilongjiang
Rheumatology Department, The first Affiliated Hospital of Harbin Medical University Active, not recruiting
Harbin, Heilongjiang, China, 150001
Rheumatology Department, The second Affiliated Hospital of Harbin Medical University Active, not recruiting
Harbin, Heilongjiang, China, 150086
China, Hunan
Xiangya Hospital of Centre-south University Recruiting
Changsha, Kaifu District, Hunan, China, 410008
China, Jiangxi
The Second Affiliated Hospital to Nanchang University Active, not recruiting
Nanchang, Jiangxi, China, 330006
China, Shanghai
Zhongshan Hospital Fudan University, Rheumatology Department Recruiting
Shanghai, Shanghai, China, 200032
China, Shanxi
Xijing Hospital, The Fourth Military Medical University Active, not recruiting
Xi'an, Shanxi, China, 710032
China, Sichuan
Si Chuan Huaxi Hospital/Rheumatology Department Recruiting
Chengdu, Sichuan, China, 610041
China, Yunnan
The First Affiliated Hospital of Kunming Medical University/ Rheumatology and Immunology Department Recruiting
Kunming, Yunnan, China, 650032
China, Zhejiang
The First Affiliated Hospital of Wenzhou Medical University/Neurology Department Recruiting
Wenzhou, Zhejiang, China, 325000
China-Japan Friendship Hospital/Rheumatology Department Active, not recruiting
Beijing, China, 100029
Peking Union Medical College Hospital/Rheumatology Department Active, not recruiting
Beijing, China, 100032
PLA. The Military General Hospital of Beijing Active, not recruiting
Beijing, China, 100700
Rheumatology and Immunology Dept., Renji Hospital Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, China, 200001
Rheumatology and Immunology Department, Shanghai Changzheng Hospital Active, not recruiting
Shanghai, China, 200003
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT01387607     History of Changes
Other Study ID Numbers: A0081241 
Study First Received: June 30, 2011
Last Updated: January 13, 2017
Health Authority: China: State Food and Drug Administration (SFDA)

Keywords provided by Pfizer:

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs processed this record on January 18, 2017