Painful Diabetic Polyneuropathy Trial With a New Centrally Acting Analgesic

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetic Polyneuropathy

Intervention / Treatment
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* Drug: GRT6005
* Drug: MS Continus®
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Dose 1, 40 µg | Drug: GRT6005<br>* liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days<br>|
| Experimental: B<br>Dose 2, 120 µg | Drug: GRT6005<br>* liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days<br>|
| Experimental: C<br>Dose 3 | Drug: GRT6005<br>* liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days<br>|
| Experimental: D<br>Dose 4 | Drug: GRT6005<br>* liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days<br>|
| Experimental: E<br>Dose 5 | Drug: GRT6005<br>* liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days<br>|
| Experimental: F<br>Dose 6 | Drug: GRT6005<br>* liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days<br>|
| Experimental: G<br>Dose 7 | Drug: GRT6005<br>* liquid formulation for oral application, 0,8 to 400 µg, single dose per day, five days<br>|
| Active Comparator: H<br>Morphin | Drug: MS Continus®<br>* 60 mg, capsule, once daily<br>|
| Placebo Comparator: I<br>Placebo | Drug: Placebo<br>* liquid formulation and capsule, once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average daily pain intensity |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life Neuropathic pain scale Amount and first time of Rescue medication Adverse events, ECG, Laboratory values |  | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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analgesic, diabetes mellitus, chronic neuropathic pain, painful polyneuropathy caused by diabetes mellitus type I or II