Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy

CompletedPhase 2NCT01347671

View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

The purpose of this trial is to investigate the efficacy and safety of GRT6005 in patients with painful diabetic neuropathy.

Study details

Official title: A Randomized 4-week Phase IIa Trial Evaluating the Efficacy, Safety, and Tolerability of GRT6005, a New Centrally Acting Analgesic, in Subjects With Pain Due to Diabetic Polyneuropathy.
Conditions: Pain
Diabetic Neuropathies
Interventions: Drug: GRT6005
Drug: GRT6005
Drug: GRT6005
Drug: Matching Placebo
Sponsor: Tris Pharma, Inc.
Collaborators: Forest Laboratories
Start date: 2011-05
Primary completion: 2012-01
Sex: All
Age range: from 18 Years to 75 Years
Results posted: No results posted in this snapshot
Countries: Bulgaria, Germany, Romania
Total sites listed: 22

Eligibility criteria

Show eligibility criteria (verbatim from the registry)

Inclusion Criteria: * Men and women, 18 to 75 years old. * Type 1 or type 2 diabetes. * Painful DPN symptoms and signs for at least 3 months. * Blood glucose controlled with medication. * Glycosylated hemoglobin not greater than 9.5 or 11%, country dependent. * Prior analgesic medication. * Average score of 4 or greater on the 11 point NRS during the last 3 days prior to randomization. Exclusion Criteria: * Impaired liver, cardiac or renal function. * Breastfeeding and pregnancy. * History of substance abuse, alcohol or medication. * Chronic gastrointestinal disease. * History of seizures and or epilepsy. * History or presence of malignancy. * Presence of painful medical conditions that are not due to diabetic neuropathy, e.g. rheumatoid arthritis. * Allergies to opioids, acetaminophen or excipients of the medications.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01347671