Clinical trial NCT00752505: A Study To Assess Esreboxetine's Effect On Concentration, Memory, Decision Making And Problem Solving In Patients With Fibromyalgia.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-15
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Computer based psychometric tests
timeFrame: 11 week
Secondary outcomes:
measure: A questionnaire to evaluate the subjects cognitive status
timeFrame: Once at randomisatoin
measure: A questionnaire to assess the subjects mood
timeFrame: 11 weeks
measure: A question to assess the subjects pain at visits
timeFrame: 11 weeks
measure: A daily diary to assess the subjects pain
timeFrame: 11 weeks
measure: A questionnaire to evaluate the impact the subject perceives fibromyalgia has on their cognitive ability
timeFrame: Once at randomisation
measure: Two questionnaires to assess change in the subjects cognitive ability
timeFrame: 11 weeks
measure: 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
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Destin
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Fort Walton Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Bingham Farms
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: