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A Study Comparing the Efficacy and Safety of ABT-652 to Placebo in Subjects With Diabetic Neuropathic Pain

This study has been terminated.
(Study Stopped)
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01579279
First received: April 16, 2012
Last updated: September 24, 2013
Last verified: August 2013

April 16, 2012
September 24, 2013
April 2012
May 2012   (final data collection date for primary outcome measure)
24-hour Average Pain Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Weekly mean of 24-hour average pain score measured by a 11-point Numeric Rating Scale completed on subject's daily diary.
Same as current
Complete list of historical versions of study NCT01579279 on ClinicalTrials.gov Archive Site
  • Neuropathic Pain Symptom Inventory [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measures severity of common neuropathic pain qualities (burning, pressure, squeezing)
  • Patient Global Impression of Change [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Captures the subject's evaluation of his/her overall general impression of feeling since beginning study medication
  • Brief Pain Inventory [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Capture the subject's severity of pain and interference
  • Neuropathic Pain Impact on Quality of Life Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Captures the subject's assessment of neuropathic pain and the effect it has on the quality of daily life
  • EuroQuality of Life - 5 Dimension -5 Level [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Capture's the subject's mobility, self-care, usual activity, pain/discomfort and anxiety/depression
Same as current
Not Provided
Not Provided
 
A Study Comparing the Efficacy and Safety of ABT-652 to Placebo in Subjects With Diabetic Neuropathic Pain
A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-652 to Placebo in Subjects With Diabetic Neuropathic Pain

To evaluate the safety and efficacy of ABT-652 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.

A double blind, randomized, active- and placebo-controlled 13-week study. Duloxetine is added to evaluate assay sensitivity.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Diabetic Neuropathic Pain
  • Drug: ABT-652 6 mg
    6 mg capsules
  • Drug: ABT-652 12 mg
    12 mg capsules
  • Drug: ABT-652 12 mg - 18 mg
    12 mg - 18 mg capsules
  • Drug: Placebo
    Placebo capsules
  • Drug: Duloxetine
    Duloxetine capsules
  • Experimental: ABT-652 6 mg
    ABT-652 capsules - twice daily
    Intervention: Drug: ABT-652 6 mg
  • Experimental: ABT-652 12 mg
    ABT-652 capsules twice daily
    Intervention: Drug: ABT-652 12 mg
  • Experimental: ABT-652 12 mg - 18 mg
    ABT-652 capsules twice daily
    Intervention: Drug: ABT-652 12 mg - 18 mg
  • Placebo Comparator: Placebo
    Placebo capsules twice daily
    Intervention: Drug: Placebo
  • Active Comparator: Duloxetine
    Duloxetine capsules once daily
    Intervention: Drug: Duloxetine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject is between the ages of 18-75 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 a mean average score of greater than 4 on the 24 hour average pain score (0-10 numerical rating scale) prior to the Baseline Visit.
  • Subject has been on a medication for diabetic neuropathic pain for the past 3 months.

Exclusion Criteria:

  • Subject has clinically symptomatic neuropathic pain conditions that cannot be distinguished from Diabetic Neuropathic Pain or interfere with the pain assessments of Diabetic Neuropathic Pain.
  • A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with Diabetic Neuropathic Pain assessments or other functions.
  • Subject has clinically significant abnormalities in clinical laboratory tests.
  • Subject has taken an opioid chronically, excluding tramadol within the last 3 months prior to Screening.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01579279
M11-210, 2011-003939-56
Yes
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Wolfram Nothaft, MD AbbVie
AbbVie
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP