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

Tracking Information

First Received Date ^ICMJE

January 23, 2008

Last Updated Date

March 17, 2009

Start Date ^ICMJE

November 2007

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00607256 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Condition ^ICMJE

Fibromyalgia

Intervention ^ICMJE

Drug: [S,S]-reboxetine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

500

Estimated Completion Date

June 2009

Estimated Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, Canada, Czech Republic, France, Germany, Korea, Republic of, Netherlands, South Africa, Sweden, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00607256

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer Inc

Study ID Numbers ^ICMJE

A6061046

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP