A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

AbbVie

Status and phase: Completed; Phase 2

Conditions: Diabetic Neuropathic Pain

Treatments: Drug: placebo; Drug: ABT-894

Study type: Interventional

Funder types: Industry

Identifiers

NCT00548925

M10-014

2007-001140-47 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of a 6 mg twice a day dose of an investigational product in subjects with diabetic neuropathy

Enrollment: 124 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females, age 18 to 75
• If female, must be of non-childbearing potential or practicing birth control
• Has diabetes mellitus (Type 1 or 2) and a diagnosis of painful distal symmetric diabetic polyneuropathy
• Has had pain from distal symmetric diabetic polyneuropathy for a minimum of 6 months
• Must be willing to washout of all analgesic medications prior to entry into the study

Exclusion criteria

• Has other conditions that may cause pain
• Currently receiving analgesic medications for conditions other than diabetic neuropathic pain
• Has a history of certain psychiatric diseases
• Has a history of certain heart or cardiovascular conditions
• Has any clinically significant recent infection, injury, or illness
• Current participation in another clinical study or participation within the past 30 days
• Is incapacitated, bedridden or confined to a wheelchair
• Is pregnant and/or breastfeeding
• Previous participation in this study or any other study with this investigational product.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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124 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: ABT-894

2

Placebo Comparator group

Treatment:

Drug: placebo