Status:
COMPLETED
Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic
Lead Sponsor:
Tris Pharma, Inc.
Conditions:
Diabetic Polyneuropathy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- Subjects with pain at least NRS \>4 due to painful diabetic polyneuropaty.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00878293
Start Date
April 1 2009
End Date
May 1 2010
Last Update
July 15 2021
Active Locations (4)
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1
Investigator 3
Bad Oeynhausen, Germany
2
Investigator 1
Mainz, Germany
3
Investigator 2
Münster, Germany
4
Investigator 4
Manchester, United Kingdom