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

NCT00752505 | Completed Phase 2

• 1 other identifier: A6061061
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 7

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Computer based psychometric tests

  11 week

Secondary Outcomes (7)

• A questionnaire to evaluate the subjects cognitive status

  Once at randomisatoin

• A questionnaire to assess the subjects mood

  11 weeks

• A question to assess the subjects pain at visits

  11 weeks

• A daily diary to assess the subjects pain

  11 weeks

• A questionnaire to evaluate the impact the subject perceives fibromyalgia has on their cognitive ability

  Once at randomisation

Study Arms (2)

A

EXPERIMENTAL

Drug: Esreboxetine

B

EXPERIMENTAL

Drug: Esreboxetine

Interventions

Esreboxetine DRUG

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

A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (7)

Pfizer Investigational Site

Destin, Florida, 32541, United States

Location

Pfizer Investigational Site

Fort Walton Beach, Florida, 32547, United States

Location

Pfizer Investigational Site

Ann Arbor, Michigan, 48109, United States

Location

Pfizer Investigational Site

Bingham Farms, Michigan, 48025, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73103, United States

Location

Pfizer Investigational Site

Austin, Texas, 78756, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75231, United States

Location

Related Links

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

MeSH Terms

Conditions

Fibromyalgia

Interventions

esreboxetine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2008
• First Posted: September 15, 2008
• Study Start: August 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: December 4, 2018

Record last verified: 2018-11

Locations

US (7)