Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy

Tris Pharma, Inc.189 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

189

Conditions

Pain Diabetic Neuropathies

Interventions

GRT6005DRUG

25µg/day once daily

GRT6005DRUG

75 µg/day once daily

GRT6005DRUG

200 µg/day once daily

Matching Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (22)

Site 4502

Sofia, Bulgaria

Site 4112

Aschaffenburg, Germany

Site 4109

Outcomes

Primary Outcomes

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".

Time frame: Baseline to Week 4

Secondary Outcomes

Response measured in percentage change of pain intensity from baseline

Time frame: End of 4 Weeks

Changes in Quantitative Sensory Testing from baseline

Time frame: Baseline, week 1 and week 4

Neuropathic Pain Scale, changes from baseline

Time frame: End of 4 weeks

Short Form of the Brief Pain Inventory, changes from baseline

Time frame: End of 4 weeks

Leeds Sleep Evaluation Questionnaire

Time frame: End of treatment

Quality of Life Index -Short-Form-12®, from baseline

Time frame: End of treatment

Patient's Global Impression of Change

Time frame: End of treatment

Quality of Life EuroQoL-5 Dimension score, change from baseline

Time frame: End of 4 weeks

Rescue medication use

Time frame: End of 4 weeks

Data from ClinicalTrials.gov

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