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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00752505
• Other study ID #: A6061061
• Status: Completed
• Phase: Phase 2
• Start date: August 2008
• Est. completion date: June 2009

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Ann Arbor	Michigan
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Bingham Farms	Michigan
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Destin	Florida
United States	Pfizer Investigational Site	Fort Walton Beach	Florida
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Computer based psychometric tests		11 week
Secondary	A questionnaire to evaluate the subjects cognitive status		Once at randomisatoin
Secondary	A questionnaire to assess the subjects mood		11 weeks
Secondary	A question to assess the subjects pain at visits		11 weeks
Secondary	A daily diary to assess the subjects pain		11 weeks
Secondary	A questionnaire to evaluate the impact the subject perceives fibromyalgia has on their cognitive ability		Once at randomisation
Secondary	Two questionnaires to assess change in the subjects cognitive ability		11 weeks
Secondary	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

External Links

•   To obtain contact information for a study center near you, click here.