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

This study has been completed.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) ) Identifier:
First received: April 28, 2011
Last updated: January 3, 2013
Last verified: January 2013
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.

Condition Intervention Phase
Diabetic Neuropathic Pain
Drug: ABT-639
Drug: pregabalin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Patient's Global Impression of Change [ Time Frame: Week 2, Week 4 and Week 6 (End of Study) ]
    Paper questionnaire

  • Brief Pain Inventory (BPI) (short form) including Severity and Interference [ Time Frame: At each visit up to Week 6 (end of Study) ]
    Paper questionnaire

  • Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Baseline, Week 2, Week 4 and Week 6 (end of Study) ]
    Paper questionnaire

Enrollment: 193
Study Start Date: April 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-639
ABT-639 twice daily for 6 weeks
Drug: ABT-639
ABT-639 Twice Daily for six weeks.
Active Comparator: pregabalin
pregabalin starting dose twice daily for week one then titrated up to maintenance dose twice daily for duration of the study
Drug: pregabalin
pregabalin starting dose twice daily for 1 week then titrated to maintenance dose twice daily for the remainder of the study.
Other Name: Lyrica
Placebo Comparator: Placebo
Placebo twice daily for 6 weeks
Drug: Placebo
Placebo twice daily for 6 weeks.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01345045

  Show 35 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Study Director: Rachel Duan, MD AbbVie
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AbbVie (prior sponsor, Abbott) Identifier: NCT01345045     History of Changes
Other Study ID Numbers: M11-891
2010-024359-99 ( EudraCT Number )
Study First Received: April 28, 2011
Last Updated: January 3, 2013

Keywords provided by AbbVie:
Diabetic Asymmetric Polyneuropathy
Symmetric Diabetic Proximal Motor Neuropathy
Diabetic Mononeuropathy Simplex,
Diabetic Autonomic Neuropathy,
Diabetic Amyotrophy
Diabetic Neuropathy
Asymmetric Diabetic Proximal Motor Neuropathy
Diabetic Polyneuropathy
Diabetic Mononeuropathy

Additional relevant MeSH terms:
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs processed this record on May 24, 2017