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

Phase 2

Terminated

• Conditions: Pain
• Interventions: Drug: [S,S]-Reboxetine; Drug: Any

• Registration Number: NCT00348894
• Lead Sponsor: Pfizer

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-04
• Study First Submitted QC: 2006-07-04
• Study First Posted: 2006-07-06
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-31
• Last Update Posted: 2011-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 136

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open Treatment	[S,S]-Reboxetine	\[S,S\]-reboxetine
Standard Care	Any	Standard Care

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Manchester, United Kingdom