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

Phase 2

Terminated

• Conditions: Diabetic Neuropathies
• Interventions: Drug: Placebo; Drug: [S,S]-Reboxetine

• Registration Number: NCT00625833
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-02-14
• Study First Submitted QC: 2008-02-19
• Study First Posted: 2008-02-28
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Disposition First Submitted: 2011-06-07
• Status Verified: 2019-12
• Disposition First Submitted QC: 2019-12-11
• Last Update Submitted: 2019-12-11
• Disposition First Posted: 2019-12-13
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 330

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
2	[S,S]-Reboxetine	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in weekly average pain score	8 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇪🇸 Valencia, Spain