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.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01345045
First received: April 28, 2011
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Paper questionnaire

  • Brief Pain Inventory (BPI) (short form) including Severity and Interference [ Time Frame: At each visit up to Week 6 (end of Study) ] [ Designated as safety issue: No ]
    Paper questionnaire

  • Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Baseline, Week 2, Week 4 and Week 6 (end of Study) ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345045

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

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01345045     History of Changes
Other Study ID Numbers: M11-891, 2010-024359-99
Study First Received: April 28, 2011
Last Updated: January 3, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Czech Republic: State Institute for Drug Control
Mexico: Federal Commission for Protection Against Health Risks
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Analgesics
Pregabalin
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on July 28, 2014