A Randomized, Double-Blind Placebo Controlled Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.

Pfizer1 site in 1 country330 target enrollmentDecember 2007

ConditionsDiabetic Neuropathies

Interventions[S,S]-Reboxetine Placebo

DrugsPlacebo [S,S]-Reboxetine

Overview

Phase: Phase 2
Intervention: [S,S]-Reboxetine
Conditions: Diabetic Neuropathies
Sponsor: Pfizer
Enrollment: 330
Locations: 1
Primary Endpoint: Change from baseline in weekly average pain score
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2007

End Date

November 2008

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

2

Intervention: [S,S]-Reboxetine

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Change from baseline in weekly average pain score

Time Frame: 8 weeks

Secondary Outcomes

Change from baseline in weekly average sleep interference scale(8 weeks)
Change from baseline in the total score and each dimension of the Neuropathic Pain Symptom Inventory(8 weeks)
Responder rates (patients with a 30% reduction from baseline in weekly average pain score and patients with a 50% reduction from baseline in weekly average pain score)(8 weeks)
Modified Brief Pain Inventory-Short Form(8 weeks)