NCT00348894
Terminated
Phase 2
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).
Overview
- Phase
- Phase 2
- Intervention
- [S,S]-Reboxetine
- Conditions
- Pain
- Sponsor
- Pfizer
- Enrollment
- 136
- Locations
- 1
- Primary Endpoint
- Vital signs
- Status
- Terminated
- Last Updated
- 14 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Open Treatment
\[S,S\]-reboxetine
Intervention: [S,S]-Reboxetine
Standard Care
Standard Care
Intervention: Any
Outcomes
Primary Outcomes
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 Outcomes
- Pain Visual Analogue 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)
- EQ-5D(duration of study)
- Analgesic Treatment Satisfaction Scale(duration of study)
- Pain-related Medication Utilization(duration of study)
Study Sites (1)
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