Overview

A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y

Status:
Terminated
Trial end date:
2011-01-01
Target enrollment:
0
Participant gender:
All
Summary
This trial is assessing the analgesic efficacy and safety of a new central analgesic in subjects with pain due to diabetic peripheral neuropathy (DPN).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GrĂ¼nenthal GmbH
Criteria
Inclusion Criteria:

- Symmetrical painful diabetic peripheral neuropathy

Exclusion Criteria:

- History of hypersensitivity, allergy or contraindication to opioids and acetaminophen

- Confounding painful conditions

- Significant vascular disease

- History or risk of seizure

- Chronic disease that might effect drug absorption, distribution, metabolism, or
excretion

- Female subjects who are being pregnant or breastfeeding

- Evidence or history of alcohol, medication, or drug abuse