Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy

Study Overview
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Brief Summary
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The purpose of this trial is to investigate the efficacy and safety of GRT6005 in patients with painful diabetic neuropathy.

Official Title
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A Randomized 4-week Phase IIa Trial Evaluating the Efficacy, Safety, and Tolerability of GRT6005, a New Centrally Acting Analgesic, in Subjects With Pain Due to Diabetic Polyneuropathy.

Conditions
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Pain, Diabetic Neuropathies

Intervention / Treatment
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* Drug: GRT6005
* Drug: GRT6005
* Drug: GRT6005
* Drug: Matching Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, 18 to 75 years old. Type 1 or type 2 diabetes. Painful DPN symptoms and signs for at least 3 months. Blood glucose controlled with medication. Glycosylated hemoglobin not greater than 9.5 or 11%, country dependent. Prior analgesic medication. Average score of 4 or greater on the 11 point NRS during the last 3 days prior to randomization. Exclusion Criteria: Impaired liver, cardiac or renal function. Breastfeeding and pregnancy. History of substance abuse, alcohol or medication. Chronic gastrointestinal disease. History of seizures and or epilepsy. History or presence of malignancy. Presence of painful medical conditions that are not due to diabetic neuropathy, e.g. rheumatoid arthritis. Allergies to opioids, acetaminophen or excipients of the medications.

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 25 µg GRT6005<br>Participants allocated to this treatment arm will receive a daily dose of 25 µg GRT6005 per day | Drug: GRT6005<br>* 25µg/day once daily<br>|
| Active Comparator: 75 µg GRT6005<br>Participants allocated to this treatment arm will receive a daily dose of 75 µg GRT6005 per day | Drug: GRT6005<br>* 75 µg/day once daily<br>|
| Active Comparator: 200 µg GRT6005<br>Participants allocated to this treatment arm will receive a daily dose of 200 µg GRT6005 per day | Drug: GRT6005<br>* 200 µg/day once daily<br>|
| Placebo Comparator: Matching Placebo<br>Participants allocated to this treatment arm will receive a dose of matched placebo once a day. | Drug: Matching Placebo<br>* Once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean daily pain intensity score | Participants will be selected based on their medical history and clinical examination. Efficacy of the treatment (i.e., reduction of pain) will be evaluated with the 11-point numeric rating scale (NRS), where 0 represents no pain and 10 represents pain as bad as you can imagine. | Baseline to Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response measured in percentage change of pain intensity from baseline |  | End of 4 Weeks | 
| Changes in Quantitative Sensory Testing from baseline |  | Baseline, week 1 and week 4 | 
| Neuropathic Pain Scale, changes from baseline |  | End of 4 weeks | 
| Short Form of the Brief Pain Inventory, changes from baseline |  | End of 4 weeks | 
| Leeds Sleep Evaluation Questionnaire |  | End of treatment | 
| Quality of Life Index -Short-Form-12®, from baseline |  | End of treatment | 
| Patient's Global Impression of Change |  | End of treatment | 
| Quality of Life EuroQoL-5 Dimension score, change from baseline |  | End of 4 weeks | 
| Rescue medication use |  | End of 4 weeks | 
| Clinical Opioid Withdrawal Scale |  | End of 4 weeks | 
| Plasma concentration |  | End of 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic pain, analgesia, analgesics, pain, neuropathic pain