Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin In Patients With Fibromyalgia. - Full Text View

Purpose

This study, will compare pregabalin with placebo for the duration of 14 weeks to evaluate the efficacy and safety of pregabalin in patients with fibromyalgia.

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 Primary Purpose: Treatment
Official Title:	A 14 Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily 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:

Change in Patient Assessment of Pain [ Time Frame: Baseline, 14 weeks (endpoint) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in Medical Outcomes Study (MOS) Sleep Disturbance Scale [ Time Frame: Baseline, 14 weeks (endpoint) ] [ Designated as safety issue: No ]
Change in Fibromyalgia Impact Questionnaire (FIQ) Total Scores [ Time Frame: Baseline, 14 weeks (endpoint) ] [ Designated as safety issue: No ]
Change in MOS Sleep Scale Scores-Other Sleep Scales [ Time Frame: Baseline, 14 weeks (endpoint) ] [ Designated as safety issue: No ]
Change in Mean Sleep Quality [ Time Frame: Baseline, 14 weeks (endpoint) ] [ Designated as safety issue: No ]
Change in Weekly Mean Sleep Quality [ Time Frame: Baseline, Week 1 through week 14 ] [ Designated as safety issue: No ]
Change in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores [ Time Frame: Baseline, 14 weeks (endpoint) ] [ Designated as safety issue: No ]
Change in Short Form-36 (SF-36) Health Survey [ Time Frame: Baseline, 14 weeks (endpoint) ] [ Designated as safety issue: No ]
Change in Multidimensional Assessment of Fatigue (MAF) [ Time Frame: Baseline, 14 weeks (endpoint) ] [ Designated as safety issue: No ]
Change in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline, 14 weeks (endpoint) ] [ Designated as safety issue: No ]
Change in Pain Visual Analogue Scale (VAS) Scores [ Time Frame: Baseline, 14 weeks (endpoint) ] [ Designated as safety issue: No ]
Change in Total Daily Acetaminophen Dose [ Time Frame: Baseline, 14 weeks (endpoint) ] [ Designated as safety issue: No ]

Enrollment:	747
Study Start Date:	July 2006
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: pregabalin 600mg/day
Experimental: 2	Drug: pregabalin 450mg/day
Experimental: 3	Drug: pregabalin 300mg/day
Placebo Comparator: 4	Drug: placebo placebo

Eligibility

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

Criteria

Inclusion Criteria:

ACR criteria for fibromyalgia
A score of more or equal to 40 mm on the Pain Visual Analog Scale (VAS) and a an average score more or equal to 4 on 4 daily pain diaries

Exclusion Criteria:

Patients with other severe pain conditions
Patients with severe depression
Patients taking excluded medications

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00333866

Show 74 Study Locations

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 by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pauer L, Winkelmann A, Arsenault P, Jespersen A, Whelan L, Atkinson G, Leon T, Zeiher B; A0081100 Investigators. An international, randomized, double-blind, placebo-controlled, phase III trial of pregabalin monotherapy in treatment of patients with fibromyalgia. J Rheumatol. 2011 Dec;38(12):2643-52. Epub 2011 Oct 1.

Straube S, Moore RA, Paine J, Derry S, Phillips CJ, Hallier E, McQuay HJ. Interference with work in fibromyalgia: effect of treatment with pregabalin and relation to pain response. BMC Musculoskelet Disord. 2011 Jun 3;12:125.

Bhadra P, Petersel D. Medical conditions in fibromyalgia patients and their relationship to pregabalin efficacy: pooled analysis of Phase III clinical trials. Expert Opin Pharmacother. 2010 Dec;11(17):2805-12. Epub 2010 Nov 2.

Bennett RM, Russell J, Cappelleri JC, Bushmakin AG, Zlateva G, Sadosky A. Identification of symptom and functional domains that fibromyalgia patients would like to see improved: a cluster analysis. BMC Musculoskelet Disord. 2010 Jun 28;11:134.

Responsible Party:	Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00333866 History of Changes
Other Study ID Numbers:	A0081100
Study First Received:	June 2, 2006
Results First Received:	November 20, 2008
Last Updated:	March 26, 2009
Health Authority:	United States: Food and Drug Administration

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 23, 2013