Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy
Launched by TRIS PHARMA, INC. · May 3, 2011
Trial Information
Current as of May 07, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- 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.
About Tris Pharma, Inc.
Tris Pharma, Inc. is a biopharmaceutical company dedicated to the development and commercialization of innovative drug formulations, particularly in the areas of central nervous system disorders and pediatric medicine. With a robust portfolio of products and a strong focus on addressing unmet medical needs, Tris leverages advanced drug delivery technologies to enhance the efficacy and safety of its therapies. Committed to scientific excellence and patient-centric solutions, Tris Pharma collaborates with healthcare professionals and regulatory bodies to ensure the highest standards of quality and compliance in its clinical trials, ultimately aiming to improve the lives of patients across diverse therapeutic areas.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sofia, , Bulgaria
Aschaffenburg, , Germany
Bad Oeynhausen, , Germany
Berlin, , Germany
Berlin, , Germany
Dresden, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hannover, , Germany
Hannover, , Germany
Heidelberg, , Germany
Kiel, , Germany
Lübeck, , Germany
Mainz, , Germany
Münster, , Germany
Schwerin, , Germany
Wangen, , Germany
Bucuresti, , Romania
Bucuresti, , Romania
Sibiu, , Romania
Timisoara, , Romania
Târgu Mureş, , Romania
Patients applied
Trial Officials
Thomas Forst, Prof. Dr.
Principal Investigator
ikfe GmbH, Institut for Klinische Forschung und Entwicklung, Parcusstr. 8, 55116 Mainz, Germany
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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