A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y

Study Overview
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Brief Summary
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This trial is assessing the analgesic efficacy and safety of a new central analgesic in subjects with pain due to diabetic peripheral neuropathy (DPN).

Official Title
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A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Trial to Assess the Analgesic Efficacy and Safety of a New Analgesic Compared to Placebo in Subjects With Painful Diabetic Peripheral Neuropathy

Conditions
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Painful Diabetic Neuropathy

Intervention / Treatment
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* Drug: GRT3938Y
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symmetrical painful diabetic peripheral neuropathy Exclusion Criteria: History of hypersensitivity, allergy or contraindication to opioids and acetaminophen Confounding painful conditions Significant vascular disease History or risk of seizure Chronic disease that might effect drug absorption, distribution, metabolism, or excretion Female subjects who are being pregnant or breastfeeding Evidence or history of alcohol, medication, or drug abuse

Ages Eligible for Study
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Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A GRT3983Y<br>Participants randomly assigned to receive GRT3983Y. | Drug: GRT3938Y<br>* Overencapsulated tablets of GRT3983Y, 100 to 300mg daily dose, 16 weeks treatment.<br>|
| Placebo Comparator: B Placebo<br>Participants randomly assigned to placebo. | Drug: Placebo<br>* Overencapsulated tablets of placebo, 16 weeks treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Pain Intensity | The primary efficacy endpoint is the change from baseline in the mean of the daily average pain intensity scores (on an 11-point NRS) over the last 7 days of the 12-week maintenance (Week 16). | Baseline; last 7 days of 12-week maintenance | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over the Entire 12-week Maintenance |  | Baseline, Daily scores over entire 12 week maintenance | 
| Proportion of Subjects Achieving Various Levels of Pain Improvement (Including 30% and 50%) Based on the Percent Change From Baseline to the Last 7 Days of the 12-week Maintenance on an 11-point NRS (Responder Analysis). |  | Baseline, Last 7 days of 12-week maintenance | 
| Change From Baseline in the Mean of the Daily Average Pain Intensity Scores (on an 11-point NRS) Over Each Week of Maintenance. |  | Baseline; daily scores over each week of maintenance | 
| Change From Baseline of the Weekly Mean of Night Pain Intensity (on an 11-point NRS). |  | Baseline; weekly mean | 
| Change From Baseline of the Weekly Mean of Current Pain Intensity (on an 11-point NRS) in the Evening and in the Morning, Respectively. |  | Baseline, weekly mean | 
| Brief Pain Inventory Scores: Changes From Baseline to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, and Day 113 (Final Visit). |  | Baseline, weekly mean | 
| Neuropathic Pain Symptoms Inventory: Changes From Baseline to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99 and Day 113 (Final Visit) |  | Baseline, weekly mean | 
| Patient Global Impression of Change Using a 7-point Verbal Rating Scale, on Day 29, Day 71 and Day 113 (Final Visit). |  | Day 29, Day 71 and Day 113. | 
| Short Form 36 Health Survey (SF-36®): Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit). |  | Baseline, Day 29, Day 71 and Day 113. | 
| EuroQol-5 Dimension Health Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit). |  | Baseline, Day 29, Day 71 and Day 113. | 
| Assessment of Each Item of the Leeds Sleep Evaluation Questionnaire: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit). |  | Baseline, Day 29, Day 71 and Day 113. | 
| Hospital Anxiety and Depression Scale: Changes From Baseline to Day 29, Day 71 and Day 113 (Final Visit). |  | Baseline, Day 29, Day 71 and Day 113. | 
| Time to Treatment Discontinuation Due to Lack of Efficacy. |  | Baseline to time to treatment discontinuation | 
| Assessment of Rescue Medication Usage During the 4-week Titration. |  | 4-week titration phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia, Diabetic Neuropathy, Neuropathic pain, Painful, Chronic pain