Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic
CompletedPhase 2NCT00878293
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 determine whether the new centrally active analgesic and MS Continus® are effective in the treatment of painful diabetic polyneuropathy.
Study details
- Official title
- A Randomized Phase IIa Trial Evaluating the Safety and Efficacy of a New Centrally Acting Analgesic in Subjects With Pain Due to Diabetic Polyneuropathy
- Conditions
- Diabetic Polyneuropathy
- Interventions
- Drug: GRT6005
- Drug: MS Continus®
- Drug: Placebo
- Sponsor
- Tris Pharma, Inc.
- Start date
- 2009-04
- Primary completion
- 2010-05
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- Germany, United Kingdom
- Total sites listed
- 4
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Subjects with pain at least NRS \>4 due to painful diabetic polyneuropaty. Exclusion Criteria: * Contraindications to, or history of allergy or hypersensitivity to morphine, fentanyl, hydrocodone, acetaminophen, heparin, polyethylene glycol 400 USP-NF or any compound planned to be used during the anesthesia, or their excipients. * non Caucasian or Hispanic. * Concomitant painful disease. * Life-long history of seizure disorder or epilepsy. * Subjects with clinical relevant cardiac and vascular diseases. * Subjects with impaired renal function * Subjects with impaired hepatic function * Female subjects who are pregnant or breastfeeding.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00878293