Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy
- Registration Number
- NCT01347671
- Lead Sponsor
- Tris Pharma, Inc.
- Brief Summary
The purpose of this trial is to investigate the efficacy and safety of GRT6005 in patients with painful diabetic neuropathy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 189
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 25 µg GRT6005 GRT6005 Participants allocated to this treatment arm will receive a daily dose of 25 µg GRT6005 per day Matching Placebo Matching Placebo Participants allocated to this treatment arm will receive a dose of matched placebo once a day. 75 µg GRT6005 GRT6005 Participants allocated to this treatment arm will receive a daily dose of 75 µg GRT6005 per day 200 µg GRT6005 GRT6005 Participants allocated to this treatment arm will receive a daily dose of 200 µg GRT6005 per day
- Primary Outcome Measures
Name Time Method Change in mean daily pain intensity score Baseline to Week 4 Participants will be selected based on their medical history and clinical examination.
Efficacy of the treatment (i.e., reduction of pain) will be evaluated with the 11-point numeric rating scale (NRS), where 0 represents no pain and 10 represents "pain as bad as you can imagine".
- Secondary Outcome Measures
Name Time Method Neuropathic Pain Scale, changes from baseline End of 4 weeks Response measured in percentage change of pain intensity from baseline End of 4 Weeks Changes in Quantitative Sensory Testing from baseline Baseline, week 1 and week 4 Leeds Sleep Evaluation Questionnaire End of treatment Quality of Life Index -Short-Form-12®, from baseline End of treatment Patient's Global Impression of Change End of treatment Quality of Life EuroQoL-5 Dimension score, change from baseline End of 4 weeks Short Form of the Brief Pain Inventory, changes from baseline End of 4 weeks Rescue medication use End of 4 weeks Clinical Opioid Withdrawal Scale End of 4 weeks Plasma concentration End of 4 weeks
Trial Locations
- Locations (22)
Site 4112
🇩🇪Aschaffenburg, Germany
Site 4109
🇩🇪Bad Oeynhausen, Germany
Site 4101
🇩🇪Berlin, Germany
Site 4111
🇩🇪Dresden, Germany
Site 4110
🇩🇪Berlin, Germany
Site 4117
🇩🇪Hamburg, Germany
Site 4108
🇩🇪Hannover, Germany
Site 4104
🇩🇪Hannover, Germany
Site 4115
🇩🇪Heidelberg, Germany
Site 4103
🇩🇪Mainz, Germany
Site 4106
🇩🇪Kiel, Germany
Site 4102
🇩🇪Lübeck, Germany
Site 4113
🇩🇪Schwerin, Germany
Site 4116
🇩🇪Wangen, Germany
Site 4405
🇷🇴Bucuresti, Romania
Site 4407
🇷🇴Sibiu, Romania
Site 4402
🇷🇴Bucuresti, Romania
Site 4406
🇷🇴Timisoara, Romania
Site 4502
🇧🇬Sofia, Bulgaria
Site 4107
🇩🇪Hamburg, Germany
Site 4105
🇩🇪Münster, Germany
Site 4401
🇷🇴Târgu-Mureş, Romania