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

TerminatedPhase 2NCT00348894
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

Brief summary (from the registry)

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

Study details

Official title
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).
Conditions
Interventions
  • Drug: [S,S]-Reboxetine
  • Drug: Any
Sponsor
Pfizer
Start date
2006-07
Primary completion
2007-10
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
Argentina, Canada, Croatia, Estonia, Finland, Germany, India, Poland, Russia, South Africa, Sweden, Ukraine, United Kingdom, United States
Total sites listed
93

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Canadian sites (6)

FacilityCityProvince
Pfizer Investigational SiteWinnipegManitoba
Pfizer Investigational SiteOttawaOntario
Pfizer Investigational SiteTorontoOntario
Pfizer Investigational SiteTorontoOntario
Pfizer Investigational SiteLavalQuebec
Pfizer Investigational SiteMontrealQuebec
Canadian sites for NCT00348894WinnipegOttawaTorontoLavalMontreal
Canadian sites for NCT00348894. 5 mapped locations with coordinates in the registry. Schematic plot, not to scale.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00348894