Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic

Tris Pharma, Inc.90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Diabetic Polyneuropathy

Interventions

GRT6005DRUG

liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days

MS Continus®DRUG

60 mg, capsule, once daily

PlaceboDRUG

liquid formulation and capsule, once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (4)

Investigator 3

Bad Oeynhausen, Germany

Investigator 1

Mainz, Germany

Investigator 2

Münster, Germany

Investigator 4

Manchester, United Kingdom

Outcomes

Primary Outcomes

Average daily pain intensity

Time frame: 5 days

Secondary Outcomes

Quality of life Neuropathic pain scale Amount and first time of Rescue medication Adverse events, ECG, Laboratory values

Time frame: 5 days

Data from ClinicalTrials.gov

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