A Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Diabetic Neuropathies

In brief

This is a trial to investigate the effectiveness and safety of \[S,S\]-Reboxetine in relieving chronic peripheral pain suffered by patients with diabetes. Some evidence for the effectiveness of \[S,S\]- Reboxetine in relieving chronic pain has been seen in 3 completed trials.

Key facts

Study ID

NCT00625833

Run by

Pfizer

People needed

330

Starts

2007-12-01

Expected to finish

2008-11-01

Last updated by the study team

2019-12-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female of any race at least 18 years of age
• Diagnosis of painful, distal, symmetrical, sensory-motor polyneuropathy, which is due to diabetes, for at least 1 year
• Patients at Visit 1 must have a score ≥40 mm on the Pain Visual Analogue Scale

You may not qualify if…

• Patients with significant hepatic impairment
• Neurological disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathic pain
• Any pain or other condition that may confound assessment or self-evaluation of the pain due to diabetic neuropathy
• Amputations other than toes
• A current or recent diagnosis (past 6 months) or episode of major depressive disorder and/or uncontrolled depression
• History of transient ischemic attack or stroke
• Myocardial infarction or unstable angina within the past three months

Where it is running

• Pfizer Investigational Site — Birmingham, Alabama, United States
• Pfizer Investigational Site — Mission Viejo, California, United States
• Pfizer Investigational Site — Denver, Colorado, United States
• Pfizer Investigational Site — New Britain, Connecticut, United States
• Pfizer Investigational Site — Waterbury, Connecticut, United States
• Pfizer Investigational Site — Tampa, Florida, United States
• Pfizer Investigational Site — Winter Haven, Florida, United States
• Pfizer Investigational Site — Lexington, Kentucky, United States
• Pfizer Investigational Site — Louisville, Kentucky, United States
• Pfizer Investigational Site — North Dartmouth, Massachusetts, United States
• Pfizer Investigational Site — Jackson, Mississippi, United States
• Pfizer Investigational Site — Tupelo, Mississippi, United States
• Pfizer Investigational Site — Marionville, Missouri, United States
• Pfizer Investigational Site — Springfield, Missouri, United States
• Pfizer Investigational Site — Elizabeth, New Jersey, United States
• Pfizer Investigational Site — Hamilton, New Jersey, United States
• Pfizer Investigational Site — Buffalo, New York, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Cranston, Rhode Island, United States
• Pfizer Investigational Site — Cumberland, Rhode Island, United States
• Pfizer Investigational Site — Myrtle Beach, South Carolina, United States
• Pfizer Investigational Site — Bartlett, Tennessee, United States
• Pfizer Investigational Site — Beaumont, Texas, United States
• Pfizer Investigational Site — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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