Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic

Diabetic Polyneuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00878293
• Other study ID #: 449723
• Status: Completed
• Phase: Phase 2
• Start date: April 2009
• Est. completion date: May 2010

Study information

• Verified date: July 2021
• Source: Tris Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Polyneuropathy
• Polyneuropathies

Intervention

Drug:
• GRT6005
liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days
• MS Continus®
60 mg, capsule, once daily
• Placebo
liquid formulation and capsule, once daily

Locations

Country	Name	City	State
Germany	Investigator 3	Bad Oeynhausen
Germany	Investigator 1	Mainz
Germany	Investigator 2	Münster
United Kingdom	Investigator 4	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Tris Pharma, Inc.

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average daily pain intensity		5 days
Secondary	Quality of life Neuropathic pain scale Amount and first time of Rescue medication Adverse events, ECG, Laboratory values		5 days