[S,S]-Reboxetine Long Term Safety Study In Chronic Painful Diabetic Peripheral Neuropathy.
TerminatedPhase 2NCT00348894
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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)
| Facility | City | Province |
|---|---|---|
| Pfizer Investigational Site | Winnipeg | Manitoba |
| Pfizer Investigational Site | Ottawa | Ontario |
| Pfizer Investigational Site | Toronto | Ontario |
| Pfizer Investigational Site | Toronto | Ontario |
| Pfizer Investigational Site | Laval | Quebec |
| Pfizer Investigational Site | Montreal | Quebec |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00348894