A Study For Pregabalin In Patients With Fibromyalgia

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01387607
First received: June 30, 2011
Last updated: August 22, 2014
Last verified: August 2014
  Purpose

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
Fibromyalgia
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 Patients 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: 324
Study Start Date: February 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01387607

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
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 Terminated
Beijing, Beijing, China, 100020
China, Guangdong
Department of Neurology,The First Affiliated Hospital Of Guangzhou Medical University Not yet recruiting
Guangzhou, Guangdong, China, 510120
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510080
The Third Affiliated Hospital Of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510630
China, Heilongjiang
Rheumatology Department, The second Affiliated Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150086
Rheumatology Department, The first Affiliated Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150001
China, Hunan
Xiangya Hospital of Centre-south University Recruiting
Changsha, Hunan, China, 410008
China, Jiangxi
The Second Affiliate Hospital to Nanchang University Not yet recruiting
Nanchang, Jiangxi, China, 330006
China, Shanxi
Xijing Hospital, The Fourth Military Medical University 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 Not yet recruiting
Wenzhou, Zhejiang, China, 325000
China
China-Japan Friendship Hospital/Rheumatology Department Recruiting
Beijing, China, 100029
Peking Union Medical College Hospital/Rheumatology Department Recruiting
Beijing, China, 100032
PLA. The Military General Hospital of Beijing Recruiting
Beijing, China, 100700
Rheumatology and Immunology Department, Shanghai Changzheng Hospital Recruiting
Shanghai, China, 200003
Rheumatology and Immunology Dept., Renji Hospital Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, China, 200001
Zhongshan Hospital Fudan University, Rheumatology Department Not yet recruiting
Shanghai, China, 200032
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01387607     History of Changes
Other Study ID Numbers: A0081241
Study First Received: June 30, 2011
Last Updated: August 22, 2014
Health Authority: China: State Food and Drug Administration (SFDA)

Keywords provided by Pfizer:
Pregabalin
fibromyalgia

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 26, 2014