[S,S]-Reboxetine Long Term Safety Study In Chronic Painful Diabetic Peripheral Neuropathy.

Overview

The purpose of this study is to assess the long-term safety and tolerability of [S,S]-Reboxetine in patients with chronic painful diabetic peripheral neuropathy

Full Title of Study: “A Phase 2b Long-Term, Randomized, Open-Label, Safety And Tolerability Trial Comparing [S,S]-Reboxetine (PNU-165442g) With Routine Care In Patients With Chronic Painful Diabetic Peripheral Neuropathy (DPN).”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2007

Interventions

  • Drug: [S,S]-Reboxetine
    • [S,S]-reboxetine
  • Drug: Any
    • Any standard of care treatment for DPN

Arms, Groups and Cohorts

  • Experimental: Open Treatment
    • [S,S]-reboxetine
  • Other: Standard Care
    • Standard Care

Clinical Trial Outcome Measures

Primary Measures

  • Vital signs
    • Time Frame: duration of study
  • Physical examination
    • Time Frame: duration of study
  • 12-lead ECG
    • Time Frame: duration of study
  • Hematology/Biochemistry
    • Time Frame: duration of study
  • Adverse events
    • Time Frame: duration of study

Secondary Measures

  • Pain Visual Analogue Scale
    • Time Frame: duration of study
  • Neuropathic Pain Symptom Inventory
    • Time Frame: duration of study
  • Modified Brief Pain Inventory-Short Form
    • Time Frame: duration of study
  • Patient Global Impression of Change
    • Time Frame: duration of study
  • SF-12 Health Survey
    • Time Frame: duration of study
  • EQ-5D
    • Time Frame: duration of study
  • Analgesic Treatment Satisfaction Scale
    • Time Frame: duration of study
  • Pain-related Medication Utilization
    • Time Frame: duration of study

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of type 1 or 2 diabetes mellitus, with painful, distal, symmetrical, sensorimotor polyneuropathy – Patients at screening must have a score >/=40 mm on the pain visual analogue scale Exclusion Criteria:

  • Patients with significant hepatic impairment – Patients with other severe pain, that may impair the self-assessment of the pain due to DPN

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Director, Clinical Trial Disclosure Group, Pfizer Inc
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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