Skip to main content
OpenTrials
Completed

NCT Number: NCT01345045

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetic Neuropathic Pain Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Mononeuropathies Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site Reference ID/Investigator# 51425, Hradec Králové, Czechia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABT-639

Drug

ABT-639 Twice Daily for six weeks.

Pregabalin

Drug

pregabalin starting dose twice daily for 1 week then titrated to maintenance dose twice daily for the remainder of the study.

Other names: Lyrica

Placebo

Drug

Placebo twice daily for 6 weeks.

Primary outcomes

  1. A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary

    Time frame: 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 outcomes

  1. Patient's Global Impression of Change

    Time frame: Week 2, Week 4 and Week 6 (End of Study)

    Paper questionnaire

  2. Brief Pain Inventory (BPI) (short form) including Severity and Interference

    Time frame: At each visit up to Week 6 (end of Study)

    Paper questionnaire

  3. Neuropathic Pain Symptom Inventory (NPSI)

    Time frame: Baseline, Week 2, Week 4 and Week 6 (end of Study)

    Paper questionnaire

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo and Active Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-639 to Placebo in Subjects With Diabetic Neuropathic Pain

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 29, 2011
Registry last updated
Jan 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.