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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Diabetic Neuropathies

Treatments: Drug: Placebo; Drug: [S,S]-Reboxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00625833

A6061037

Details and patient eligibility

About

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.

Enrollment: 330 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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330 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

2

Experimental group

Treatment:

Drug: [S,S]-Reboxetine