Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy (NCT01347671) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy
Bulgaria, Germany189 participantsStarted 2011-05
Plain-language summary
The purpose of this trial is to investigate the efficacy and safety of GRT6005 in patients with painful diabetic neuropathy.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.