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

This study has been terminated.

( This study has been terminated early as the esreboxetine development program is being discontinued. There are no safety or efficacy concerns. )

First Received: January 23, 2008 Last Updated: March 17, 2009 History of Changes

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

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

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

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:

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:	June 2009
Estimated Primary Completion Date:	June 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

Show 79 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:	A6061046
Study First Received:	January 23, 2008
Last Updated:	March 17, 2009
ClinicalTrials.gov Identifier:	NCT00607256 History of Changes
Health Authority:	United States: Food and Drug Administration

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 November 27, 2009