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

Conditions: Diabetic Neuropathic Pain
MedDRA version: 13.1Level: LLTClassification code 10067547Term: Diabetic peripheral neuropathic painSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2010-024359-99-DE

Lead Sponsor: Abbott GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

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 = 4 on the 24 hour average pain score (0-10 numerical rating scale) collected over approximately 7 days prior to the Baseline Visit.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

• Subject has clinically symptomatic neuropathic pain conditions that can not be distinguished from 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the analgesic efficacy and the safety of ABT-639 (100 mg capsules) administered twice daily to placebo in the treatment of diabetic neuropathic pain (DNP). Pregabalin 150 mg administered twice daily will be assessed for assay sensitivity.;Secondary Objective: To explore the pharmacokinetic and pharmacogenetic characteristics of ABT-639 in the DNP population.;Primary end point(s): The weekly mean of the 24-hour average pain score measured by the 11-point numeric rating Scale and calculated from subject's daily diary. ;Timepoint(s) of evaluation of this end point: Weekly

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Patient’s Global Impression of Change.<br>• Brief Pain Inventory (BPI) (short form) including Severity and Interference <br>• Neuropathic Pain Symptom Inventory (NPSI)<br>• Neuropathic Pain Impact on Quality of Life Questionnaire<br>• Euro-Qol-5D<br>• Quality of Sleep Score from the Daily Sleep Diary<br>• Rescue medication<br>;Timepoint(s) of evaluation of this end point: Each Study visit