Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic

Tris Pharma

Status and phase: Completed; Phase 2

Conditions: Diabetic Polyneuropathy

Treatments: Drug: Placebo; Drug: GRT6005; Drug: MS Continus®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00878293

449723

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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90 participants in 9 patient groups, including a placebo group

A

Experimental group

Description:

Dose 1, 40 µg

Treatment:

Drug: GRT6005

B

Experimental group

Description:

Dose 2, 120 µg

Treatment:

Drug: GRT6005

C

Experimental group

Description:

Dose 3

Treatment:

Drug: GRT6005

D

Experimental group

Description:

Dose 4

Treatment:

Drug: GRT6005

E

Experimental group

Description:

Dose 5

Treatment:

Drug: GRT6005

F

Experimental group

Description:

Dose 6

Treatment:

Drug: GRT6005

G

Experimental group

Description:

Dose 7

Treatment:

Drug: GRT6005

H

Active Comparator group

Description:

Morphin

Treatment:

Drug: MS Continus®

I

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo