Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic
Phase 2
Completed
- Conditions
- Diabetic Polyneuropathy
- Interventions
- Registration Number
- NCT00878293
- Lead Sponsor
- Tris Pharma, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description I Placebo Placebo H MS Continus® Morphin D GRT6005 Dose 4 F GRT6005 Dose 6 G GRT6005 Dose 7 A GRT6005 Dose 1, 40 µg B GRT6005 Dose 2, 120 µg C GRT6005 Dose 3 E GRT6005 Dose 5
- Primary Outcome Measures
Name Time Method Average daily pain intensity 5 days
- Secondary Outcome Measures
Name Time Method Quality of life Neuropathic pain scale Amount and first time of Rescue medication Adverse events, ECG, Laboratory values 5 days
Trial Locations
- Locations (4)
Investigator 3
🇩🇪Bad Oeynhausen, Germany
Investigator 1
🇩🇪Mainz, Germany
Investigator 2
🇩🇪Münster, Germany
Investigator 4
🇬🇧Manchester, United Kingdom