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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Pain

Treatments: Drug: [S,S]-Reboxetine; Drug: Any

Study type: Interventional

Funder types: Industry

Identifiers

NCT00348894

A6061031

Details and patient eligibility

About

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

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Open Treatment

Experimental group

Description:

\[S,S\]-reboxetine

Treatment:

Drug: [S,S]-Reboxetine

Standard Care

Other group

Description:

Standard Care

Treatment:

Drug: Any