TerminatedPhase 2

A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y

Stopped: Trial was stopped due to difficult enrolment

United States553 participantsStarted 2009-11

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Average Pain Intensity

Timeframe: Baseline; last 7 days of 12-week maintenance

Trial details

NCT IDNCT01056315

SponsorGrünenthal GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-01

Results submitted2012-04-05

View on ClinicalTrials.gov More Painful Diabetic Neuropathy trials