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

Phase 2

Completed

• Conditions: Diabetic Neuropathic Pain
• Interventions: Drug: Placebo; Drug: pregabalin; Drug: ABT-639

• Registration Number: NCT01345045
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-28
• Study First Submitted QC: 2011-04-28
• Study First Posted: 2011-04-29
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Disposition First Submitted: 2012-10-26
• Disposition First Submitted QC: 2012-10-26
• Disposition First Posted: 2012-10-31
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-03
• Last Update Posted: 2013-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo twice daily for 6 weeks
pregabalin	pregabalin	pregabalin starting dose twice daily for week one then titrated up to maintenance dose twice daily for duration of the study
ABT-639	ABT-639	ABT-639 twice daily for 6 weeks

Primary Outcome Measures

Name	Time	Method
A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary	Weekly started at Baseline, Week 1, Week 2, Week 4, and Week 6 (End of Study)	Daily questions asked on a hand held diary

Secondary Outcome Measures

Name	Time	Method
Patient's Global Impression of Change	Week 2, Week 4 and Week 6 (End of Study)	Paper questionnaire
Brief Pain Inventory (BPI) (short form) including Severity and Interference	At each visit up to Week 6 (end of Study)	Paper questionnaire
Neuropathic Pain Symptom Inventory (NPSI)	Baseline, Week 2, Week 4 and Week 6 (end of Study)	Paper questionnaire

Trial Locations

Locations (35)

Site Reference ID/Investigator# 51548; 🇺🇸 Dallas, Texas, United States

Site Reference ID/Investigator# 51302; 🇺🇸 Omaha, Nebraska, United States

Site Reference ID/Investigator# 52743; 🇺🇸 Portland, Oregon, United States

Site Reference ID/Investigator# 51424; 🇨🇿 Olomouc, Czech Republic

Site Reference ID/Investigator# 51924; 🇫🇷 Le Creusot, France

Site Reference ID/Investigator# 51807; 🇺🇸 Little Rock, Arkansas, United States

Site Reference ID/Investigator# 51946; 🇺🇸 Anaheim, California, United States

Site Reference ID/Investigator# 51468; 🇺🇸 Long Beach, California, United States

Site Reference ID/Investigator# 52744; 🇺🇸 Walnut Creek, California, United States

Site Reference ID/Investigator# 51079; 🇺🇸 Clearwater, Florida, United States

Site Reference ID/Investigator# 51076; 🇺🇸 Hialeah, Florida, United States

Site Reference ID/Investigator# 51945; 🇺🇸 Hollywood, Florida, United States

Site Reference ID/Investigator# 51077; 🇺🇸 Ocala, Florida, United States

Site Reference ID/Investigator# 51804; 🇺🇸 Brockton, Massachusetts, United States

Site Reference ID/Investigator# 51263; 🇺🇸 St. Louis, Missouri, United States

Site Reference ID/Investigator# 51268; 🇺🇸 St. Louis, Missouri, United States

Site Reference ID/Investigator# 51271; 🇺🇸 Flushing, New York, United States

Site Reference ID/Investigator# 51425; 🇨🇿 Hradec Kralove, Czech Republic

Site Reference ID/Investigator# 51426; 🇨🇿 Mor Ostrava, Czech Republic

Site Reference ID/Investigator# 51269; 🇺🇸 Renton, Washington, United States

Site Reference ID/Investigator# 51806; 🇺🇸 Altoona, Pennsylvania, United States

Site Reference ID/Investigator# 51265; 🇺🇸 Tipton, Pennsylvania, United States

Site Reference ID/Investigator# 51428; 🇨🇿 Prague 10, Czech Republic

Site Reference ID/Investigator# 51427; 🇨🇿 Zlin, Czech Republic

Site Reference ID/Investigator# 51423; 🇨🇿 Prague 6, Czech Republic

Site Reference ID/Investigator# 51503; 🇩🇪 Berlin, Germany

Site Reference ID/Investigator# 51925; 🇫🇷 Venissieux, France

Site Reference ID/Investigator# 51502; 🇩🇪 Mainz, Germany

Site Reference ID/Investigator# 51642; 🇩🇪 Duesseldorf, Germany

Site Reference ID/Investigator# 51505; 🇲🇽 Guadalajara, Jal., Mexico

Site Reference ID/Investigator# 51522; 🇲🇽 Monterrey, N.L., Mexico

Site Reference ID/Investigator# 52346; 🇩🇪 Muenster, Germany

Site Reference ID/Investigator# 51504; 🇲🇽 Mexico D.F., Mexico

Site Reference ID/Investigator# 51506; 🇲🇽 Monterrey, N.L., Mexico

Site Reference ID/Investigator# 51078; 🇺🇸 Orlando, Florida, United States