Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic (NCT00878293) | Clinical Trial Compass
CompletedPhase 2
Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic
Germany, United Kingdom90 participantsStarted 2009-04
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.