Conditions: Painful Diabetic Neuropathy
Keywords: Analgesia Diabetic Neuropathy Neuropathic pain Painful Chronic pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 553
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: Participants randomly assigned to receive GRT3983Y. arm 2: Participants randomly assigned to placebo.

Interventions: intervention 1: GRT3938Y intervention 2: Placebo
Intervention descriptions: intervention 1: Overencapsulated tablets of GRT3983Y, 100 to 300mg daily dose, 16 weeks treatment. intervention 2: Overencapsulated tablets of placebo, 16 weeks treatment.

Protocol document: