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A Study For Pregabalin In Patients With Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01387607
Recruitment Status : Completed
First Posted : July 4, 2011
Last Update Posted : March 3, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: pregabalin Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 343 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 14-week, Randomized, Double-blind Placebo-controlled Study For Pregabalin In Subjects With Fibromyalgia
Study Start Date : February 2012
Primary Completion Date : October 2016
Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Pregabalin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Pregabalin Drug: pregabalin
Pregabalin capsule, 300-450mg/day, twice daily
Placebo Comparator: Placebo
Matched placebo
Drug: placebo
Placebo, twice daily

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387607

China, Anhui
Department of Rheumatism And Immunity, The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 233000
Anhui Province Hospital
Hefei, Anhui, China, 230001
China, Beijing
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing, China, 100020
China, Chongqing
Southwest Hospital of the Third Military Medical University,PLA
Chongqing, Chongqing, China, 400038
China, Guangdong
Department of Neurology,General Hospital of Guangzhou Military Command of PLA
Guangzhou, Guangdong, China, 510010
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
Department of Neurology,The First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong, China, 510120
China, Heilongjiang
Rheumatology Department, The first Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001
Rheumatology Department, The second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150086
China, Hunan
Xiangya Hospital of Centre-south University
Changsha, Kaifu District, Hunan, China, 410008
China, Jiangxi
The Second Affiliated Hospital to Nanchang University
Nanchang, Jiangxi, China, 330006
China, Shanghai
Zhongshan Hospital Fudan University, Rheumatology Department
Shanghai, Shanghai, China, 200032
China, Shanxi
Xijing Hospital, The Fourth Military Medical University
Xi'an, Shanxi, China, 710032
China, Sichuan
Si Chuan Huaxi Hospital/Rheumatology Department
Chengdu, Sichuan, China, 610041
China, Yunnan
The First Affiliated Hospital of Kunming Medical University/ Rheumatology and Immunology Department
Kunming, Yunnan, China, 650032
China, Zhejiang
The First Affiliated Hospital of Wenzhou Medical University/Neurology Department
Wenzhou, Zhejiang, China, 325000
China-Japan Friendship Hospital/Rheumatology Department
Beijing, China, 100029
Peking Union Medical College Hospital/Rheumatology Department
Beijing, China, 100032
PLA. The Military General Hospital of Beijing
Beijing, China, 100700
Rheumatology and Immunology Dept., Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200001
Rheumatology and Immunology Department, Shanghai Changzheng Hospital
Shanghai, China, 200003
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01387607     History of Changes
Other Study ID Numbers: A0081241
First Posted: July 4, 2011    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017

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