A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Painful Diabetic Neuropathy

In brief

This trial is assessing the analgesic efficacy and safety of a new central analgesic in subjects with pain due to diabetic peripheral neuropathy (DPN).

Key facts

Study ID

NCT01056315

Run by

Grünenthal GmbH

People needed

553

Starts

2009-11-01

Expected to finish

2011-01-01

Last updated by the study team

2019-10-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Symmetrical painful diabetic peripheral neuropathy

You may not qualify if…

• 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

Where it is running

• Site 130 — Homewood, Alabama, United States
• Site 112 — Tucson, Arizona, United States
• Site 129 — Escondido, California, United States
• Site 209 — Fullerton, California, United States
• Site 135 — Long Beach, California, United States
• Site 202 — Northridge, California, United States
• Site 208 — Northridge, California, United States
• Site 219 — Northridge, California, United States
• Site 203 — San Francisco, California, United States
• Site 116 — Santa Ana, California, United States
• Site 118 — Santa Ana, California, United States
• Site 121 — Santa Ana, California, United States
• Site 133 — Santa Ana, California, United States
• Site 126 — Vista, California, United States
• Site 214 — Vista, California, United States
• Site 201 — Waterbury, Connecticut, United States
• Site 136 — Deerfield Beach, Florida, United States
• Site 137 — Deerfield Beach, Florida, United States
• Site 140 — Deerfield Beach, Florida, United States
• Site 216 — Deerfield Beach, Florida, United States
• Site 217 — Deerfield Beach, Florida, United States
• Site 218 — Deerfield Beach, Florida, United States
• Site 117 — Fort Myers, Florida, United States
• Site 124 — Jacksonville, Florida, United States
• Site 127 — Fairhope, Alabama, United States

Full record on ClinicalTrials.gov

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