A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y

Grünenthal

Status and phase: Terminated; Phase 2

Conditions: Painful Diabetic Neuropathy

Treatments: Drug: Placebo; Drug: GRT3938Y

Study type: Interventional

Funder types: Industry

Identifiers

NCT01056315

131885

Details and patient eligibility

About

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

Enrollment: 553 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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553 participants in 2 patient groups, including a placebo group

A GRT3983Y

Experimental group

Description:

Participants randomly assigned to receive GRT3983Y.

Treatment:

Drug: GRT3938Y

B Placebo

Placebo Comparator group

Description:

Participants randomly assigned to placebo.

Treatment:

Drug: Placebo