A 14-Week, Multi-Center Study of [S,S]-Reboxetine in Patients With Fibromyalgia. - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00612170

Purpose

This is a study to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving the symptoms of Fibromyalgia in patients. A previous study demonstrated clinically meaningful treatment effects in fibromyalgia, based on pain and functional endpoints.

Condition	Intervention	Phase
Fibromyalgia	Drug: [S,S]-Reboxetine Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily (O.D.) in Patients With Fibromyalgia

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia

Drug Information available for: Reboxetine Reboxetine mesylate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline in the endpoint mean pain score [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Fibromyalgia Impact Questionnaire [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in the endpoint mean sleep interference score [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Patient Global Impression of Change [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Multidimensional Assessment of Fatigue [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Hospital Anxiety and Depression Scale [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Short Form 36 [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Sheehan Disability Score [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Pain Visual Analogue Scale [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Enrollment:	1129
Study Start Date:	December 2007
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
3: Experimental	Drug: [S,S]-Reboxetine 10 mg oral tablet once a day dosing
4: Sham Comparator	Drug: Placebo 0 mg oral tablet once a day dosing
1: Experimental	Drug: [S,S]-Reboxetine 4 mg oral tablet once a day dosing
2: Experimental	Drug: [S,S]-Reboxetine 8 mg oral tablet once a day dosing

Eligibility

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

Criteria

Inclusion Criteria:

Male or female of any race, at least 18 years of age
Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)

Exclusion Criteria:

Patients with other severe pain (eg, Diabetic Peripheral Neuropathy and PostHerpetic Neuralgia) that may confound assessment or self evaluation of the pain associated with fibromyalgia
Patients with any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), active infection, or untreated endocrine disorder
A current or recent diagnosis (last 6 months) or episode of major depressive disorder, dysthymia and/or uncontrolled depression
History of mania, hypomania, other psychotic disorder, or current mood disorder with psychotic features

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612170

Show 146 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

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6061043, A6061043
Study First Received:	January 29, 2008
Last Updated:	July 9, 2009
ClinicalTrials.gov Identifier:	NCT00612170 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Phase 3, safety and efficacy study, [S,S[-Reboxetine, Fibromyalgia

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Fibromyalgia
Myofascial Pain Syndromes
Physiological Effects of Drugs
Nervous System Diseases
Psychotropic Drugs

Rheumatic Diseases
Pharmacologic Actions
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Therapeutic Uses
Central Nervous System Agents
Antidepressive Agents
Reboxetine

ClinicalTrials.gov processed this record on February 08, 2010