A Study For Pregabalin In Patients With Fibromyalgia - Full Text View

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:

MedlinePlus related topics: Fibromyalgia

Drug Information available for: Pregabalin

U.S. FDA Resources

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

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
Anhui Province Hospital	Recruiting
Hefei, Anhui, China, 230001
China, Beijing
Beijing Chaoyang Hospital, Capital University of Medical Science	Recruiting
Beijing, Beijing, China, 100020
China, Guangdong
The Third Affiliated Hospital Of Sun Yat-sen University	Recruiting
Guangzhou, Guangdong, China, 510630
Guangdong General Hospital	Recruiting
Guangzhou, Guangdong, China, 510080
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, 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
China-Japan Friendship Hospital/Rheumatology Department	Recruiting
Beijing, China, 100029
Peking Union Medical College Hospital	Recruiting
Beijing, China, 100032
Rheumatology and Immunology Dept., Renji Hospital Shanghai Jiao Tong University School of Medicine	Recruiting
Shanghai, China, 200001
Rheumatology and Immunology Department, Shanghai Changzheng Hospital	Recruiting
Shanghai, China, 200003

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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:	April 29, 2013
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

ClinicalTrials.gov processed this record on May 19, 2013