A Multicenter Study Comparing the Analgesic Effects and Safety of ABT-639 Compared to Placebo in Subjects With Diabetic Neuropathic Pain

AbbVie

Status and phase: Completed; Phase 2

Conditions: Diabetic Neuropathic Pain

Treatments: Drug: pregabalin; Drug: Placebo; Drug: ABT-639

Study type: Interventional

Funder types: Industry

Identifiers

NCT01345045

2010-024359-99 (EudraCT Number)

M11-891

Details and patient eligibility

About

People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.

Enrollment: 193 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is between the ages of 18 to 75 years with a diagnosis of diabetes mellitus and must have a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months.
• Subject must have an average score of greater than or equal to ( ≥) 4 on the 24 hour average pain score (0-10 numerical rating scale) collected over approximately 7 days prior to the Baseline Visit.

Exclusion criteria

• Subject has clinically symptomatic neuropathic pain conditions that can not be distinguished from Diabetic Neuropathic Pain (DNP) or interfere with the pain assessments of DNP.
• A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with DNP assessments or other functions.
• Subject has clinically significant abnormalities in clinical laboratory tests.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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193 participants in 3 patient groups, including a placebo group

ABT-639

Experimental group

Description:

ABT-639 twice daily for 6 weeks

Treatment:

Drug: ABT-639

pregabalin

Active Comparator group

Description:

pregabalin starting dose twice daily for week one then titrated up to maintenance dose twice daily for duration of the study

Treatment:

Drug: pregabalin

Placebo

Placebo Comparator group

Description:

Placebo twice daily for 6 weeks

Treatment:

Drug: Placebo