Long-Term OL Study of [S,S]-RBX in Patients With Fibromyalgia - Full Text View

Purpose

To evaluate the lon-term safety and tolerability of [S,S]-reboxetine in patients with fibromyalgia

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

MedlinePlus related topics:

Fibromyalgia

Drug Information available for:

Reboxetine Reboxetine mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Official Title:	A Multi-Center, Long-Term, Open-Label Study of [S,S]-Reboxetine (PNU-165442G) Administered Once Daily in Patients With Fibromyalgia

Further study details as provided by Pfizer:

Primary Outcome Measures:

12-lead ECG [ Time Frame: 68 weeks ] [ Designated as safety issue: No ]
Hematology/Biochemistry [ Time Frame: 68 weeks ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: 68 weeks ] [ Designated as safety issue: No ]
Physical examination [ Time Frame: 68 weeks ] [ Designated as safety issue: No ]
Vital signs [ Time Frame: 68 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient Global Impression of Change [ Time Frame: 68 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	November 2007
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Open Label: Experimental	Drug: [S,S]-reboxetine S_S reboxetine dosed daily.

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosis of patients meeting the ACR criteria for fibromyalgia (i.e. 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 (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607256

Contacts


Contact: www.FibrolsReal.com	1-877-29-FIBRO

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

Show 79 Study Locations

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6061046
First Received:	January 23, 2008
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00607256
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Muscular Diseases

Neuromuscular Diseases

Musculoskeletal Diseases

Myofascial Pain Syndromes

Fibromyalgia

Pain

Rheumatic Diseases

Reboxetine

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Adrenergic Uptake Inhibitors

Therapeutic Uses

Physiological Effects of Drugs

Nervous System Diseases

Psychotropic Drugs

Central Nervous System Agents

Pharmacologic Actions

Antidepressive Agents

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00607256