Diabetic Polyneuropathy
Conditions
Keywords
analgesic, diabetes mellitus, chronic neuropathic pain, painful polyneuropathy caused by diabetes mellitus type I or II
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.
Interventions
DRUGGRT6005
liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
DRUGMS Continus®
60 mg, capsule, once daily
DRUGPlacebo
liquid formulation and capsule, once daily
Sponsors
Tris Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average daily pain intensity | 5 days |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life Neuropathic pain scale Amount and first time of Rescue medication Adverse events, ECG, Laboratory values | 5 days |
Countries
Germany, United Kingdom
Outcome results
None listed