A Study To Assess Esreboxetine's Effect On Concentration, Memory, Decision Making And Problem Solving In Patients With Fibromyalgia.

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00752505

First received: September 12, 2008

Last updated: June 7, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2008

Last Updated Date

June 7, 2011

Start Date ^ICMJE

August 2008

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Computer based psychometric tests [ Time Frame: 11 week ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00752505 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

A questionnaire to evaluate the subjects cognitive status [ Time Frame: Once at randomisatoin ] [ Designated as safety issue: No ]
A questionnaire to assess the subjects mood [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
A question to assess the subjects pain at visits [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
A daily diary to assess the subjects pain [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
A questionnaire to evaluate the impact the subject perceives fibromyalgia has on their cognitive ability [ Time Frame: Once at randomisation ] [ Designated as safety issue: No ]
Two questionnaires to assess change in the subjects cognitive ability [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
Safety evaluations: medical history, physical and neurological exam, heart rate and blood pressure lying and standing, laboratory tests, electrical heart trace (ECG), adverse event collection, assessment of suicidal risk [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Safety evaluations: medical history, physical and neurological exam, heart rate and blood pressure lying and standing, laboratory tests, electrical heart trace (ECG), adverse event collection, assessment of suicidal risk [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Questionnaires to assess psychometric characteristics of fibromyalgia [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
A questionnaire to assess the subjects mood [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
A questionnaire to assess the subjects pain at visits [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
A daily diary to assess the subjects pain [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study To Assess Esreboxetine's Effect On Concentration, Memory, Decision Making And Problem Solving In Patients With Fibromyalgia.

Official Title ^ICMJE

A Phase 2 Randomized Double-Blind Placebo-Controlled Crossover Study Assessing The Ability Of Esreboxetine (PNU-165442g) To Improve Cognitive Function In Fibromyalgia Patients.

Brief Summary

The study is designed to assess if esreboxetine can improve the cognitive function of patients with fibromyalgia. Cognitive function is defined as the ability to concentrate, remember things and make decisions or problem solve. The study is also designed to assess if there is a difference in cognitive function between fibromyalgia patients and matched control subjects.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Fibromyalgia

Intervention ^ICMJE

Drug: Esreboxetine

Tablet once daily either placebo, 4mg or 8mg per day. Subjects will be on active treatment for 4 weeks out of a total of 11 weeks in a crossover dosing

Study Arm (s)

Experimental: A
Intervention: Drug: Esreboxetine
Experimental: B
Intervention: Drug: Esreboxetine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2009

Primary Completion Date

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

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subjects who have a recognised diagnosis of fibromyalgia, with defined minimum pain criteria. Control subjects must not have a fibromyalgia diagnosis or symptoms and must match fibromyalgia subjects for age, length of education and gender

Exclusion Criteria:

Other confounding pain, cognitive disease or impairment, disease that could put the subject at risk or subjects who are on prohibited medications that cannot be washed out.
Any subjects with a diagnosis of certain psychiatric disorders in particular major depression or suicidal risk. Matched control subjects have similar exclusions.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00752505

Other Study ID Numbers ^ICMJE

A6061061

Has Data Monitoring Committee

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

June 2011

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

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