Maintenance of Efficacy - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00796601

Purpose

The hypothesis of Study A6061054 is to demonstrate superiority of efficacy of esreboxetine at 3 and 6 months compared to placebo.

Condition	Intervention	Phase
Fibromyalgia	Drug: Esreboxetine Drug: Placebo	Phase III

MedlinePlus related topics: Fibromyalgia

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A 6-Month, Double-Blind, Placebo-Controlled, Multi-Center, Parallel Group, Maintenance Of Effect Study Of Esreboxetine (PNU-165442g) Administered Once Daily (QD) In Patients With Fibromyalgia.

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline to 3 and 6 months in the mean daily pain rating score measured by the 11 point pain intensity Numerical Rating Scale (NRS). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change from baseline to 3 and 6 months in the FIQ-Total score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pain (including other measures of daily pain and responder analyses); [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Function (including sub-scales of the FIQ, responder analyses of FIQ and SF-36); [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Global efficacy measures PGIC); [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Sleep (MOS); [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Work productivity; [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Depression (HADS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Safety (vital signs, ECG, laboratory, suicidal ideation) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	650
Study Start Date:	May 2009
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Esreboxetine: Experimental	Drug: Esreboxetine Film coated tablets (2, 6, 8, 10 mg esreboxetine), once daily for 6 months
Placebo: Placebo Comparator	Drug: Placebo Film coated tablets (0 mg esreboxetine), once daily for 6 months

Eligibility

Criteria

Inclusion Criteria:

Subjects must meet the American College of Rheumatology (ACR) criteria for fibromyalgia
Pain score greater than or equal to 4 on an 11-point NRS
FIQ-Total score greater than or equal to 45 points

Exclusion Criteria:

Other severe pain that may confound assessment or self evaluation of the pain associated with fibromyalgia
Any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), clinically significant active infection, or untreated endocrine disorder
Uncontrolled hypertension Pending Worker's Compensation; Current or recent diagnosis or episode of major depressive disorder, dysthymia and/or uncontrolled depression; Subjects to be at risk of suicide;

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796601

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6061054, A6061054
Study First Received:	November 20, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00796601
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

double-blind placebo-controlled maintenance of efficacy

Study placed in the following topic categories:

Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes

Fibromyalgia
Pain
Rheumatic Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009