A Randomized Phase IIa Trial Evaluating the Safety and Efficacy of a New Centrally Acting Analgesic in Subjects With Pain Due to Diabetic Polyneuropathy

Tris Pharma, Inc.4 sites in 2 countries90 target enrollmentApril 2009

ConditionsDiabetic Polyneuropathy

InterventionsMS Continus®GRT6005 Placebo

DrugsGRT6005 MS Continus®Placebo

Overview

Phase: Phase 2
Intervention: MS Continus®
Conditions: Diabetic Polyneuropathy
Sponsor: Tris Pharma, Inc.
Enrollment: 90
Locations: 4
Primary Endpoint: Average daily pain intensity
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2009

End Date

May 2010

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Tris Pharma, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.