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

Pfizer logo

Pfizer

Status and phase

Completed
Phase 2

Conditions

Fibromyalgia

Treatments

Drug: Esreboxetine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00752505
A6061061

Details and patient eligibility

About

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.

Enrollment

89 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

89 participants in 2 patient groups

A
Experimental group
Treatment:
Drug: Esreboxetine
Drug: Esreboxetine
B
Experimental group
Treatment:
Drug: Esreboxetine
Drug: Esreboxetine

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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