Pain
Conditions
Brief summary
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
Interventions
DRUG[S,S]-Reboxetine
\[S,S\]-reboxetine
DRUGAny
Any standard of care treatment for DPN
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs | duration of study |
| Physical examination | duration of study |
| 12-lead ECG | duration of study |
| Hematology/Biochemistry | duration of study |
| Adverse events | duration of study |
Secondary
| Measure | Time frame |
|---|---|
| EQ-5D | duration of study |
| Pain Visual Analogue Scale | duration of study |
| Pain-related Medication Utilization | duration of study |
| Analgesic Treatment Satisfaction Scale | duration of study |
| Neuropathic Pain Symptom Inventory | duration of study |
| Modified Brief Pain Inventory-Short Form | duration of study |
| Patient Global Impression of Change | duration of study |
| SF-12 Health Survey | duration of study |
Countries
Argentina, Canada, Croatia, Estonia, Finland, Germany, India, Poland, Russia, South Africa, Sweden, Ukraine, United Kingdom, United States
Outcome results
None listed