NCT01056315

A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y

A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Trial to Assess the Analgesic Efficacy and Safety of a New Analgesic Compared to Placebo in Subjects With Painful Diabetic Peripheral Neuropathy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 553 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Painful Diabetic Neuropathy

Interventions

Type	Name	Description
DRUG	GRT3938Y	Overencapsulated tablets of GRT3983Y, 100 to 300mg daily dose, 16 weeks treatment.
DRUG	Placebo	Overencapsulated tablets of placebo, 16 weeks treatment.

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-01-26
• Last updated: 2019-10-28
• Results posted: 2012-05-03

Locations

61 sites across 1 country: United States