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

Phase 2

Completed

• Conditions: Fibromyalgia
• Interventions: Drug: Esreboxetine

• Registration Number: NCT00752505
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-09-12
• Study First Submitted QC: 2008-09-12
• Study First Posted: 2008-09-15
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Disposition First Submitted: 2011-06-07
• Disposition First Submitted QC: 2011-06-07
• Disposition First Posted: 2011-06-21
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-30
• Last Update Posted: 2018-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Esreboxetine	-
B	Esreboxetine	-

Primary Outcome Measures

Name	Time	Method
Computer based psychometric tests	11 week

Secondary Outcome Measures

Name	Time	Method
A questionnaire to evaluate the subjects cognitive status	Once at randomisatoin
A question to assess the subjects pain at visits	11 weeks
A questionnaire to assess the subjects mood	11 weeks
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	12 weeks
A daily diary to assess the subjects pain	11 weeks
Two questionnaires to assess change in the subjects cognitive ability	11 weeks
A questionnaire to evaluate the impact the subject perceives fibromyalgia has on their cognitive ability	Once at randomisation

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Dallas, Texas, United States