Safety and Efficacy of GRT6005 in Pain Due to Diabetic Polyneuropathy

Tris Pharma

Status and phase: Completed; Phase 2

Conditions: Diabetic Neuropathies; Pain

Treatments: Drug: GRT6005; Drug: Matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01347671

430409

2010-022557-42 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 189 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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189 participants in 4 patient groups, including a placebo group

25 µg GRT6005

Active Comparator group

Description:

Participants allocated to this treatment arm will receive a daily dose of 25 µg GRT6005 per day

Treatment:

Drug: GRT6005

Drug: GRT6005

Drug: GRT6005

75 µg GRT6005

Active Comparator group

Description:

Participants allocated to this treatment arm will receive a daily dose of 75 µg GRT6005 per day

Treatment:

Drug: GRT6005

Drug: GRT6005

Drug: GRT6005

200 µg GRT6005

Active Comparator group

Description:

Participants allocated to this treatment arm will receive a daily dose of 200 µg GRT6005 per day

Treatment:

Drug: GRT6005

Drug: GRT6005

Drug: GRT6005

Matching Placebo

Placebo Comparator group

Description:

Participants allocated to this treatment arm will receive a dose of matched placebo once a day.

Treatment:

Drug: Matching Placebo