Back to resultsA Study Comparing the Efficacy and Safety of ABT-652 to Placebo in Subjects With Diabetic Neuropathic Pain
Primary Purpose
Diabetic Neuropathic Pain
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ABT-652 6 mg
ABT-652 12 mg
ABT-652 12 mg - 18 mg
Placebo
Duloxetine
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathic Pain focused on measuring Diabetic neuropathic pain, Active controlled phase 2 study
Eligibility Criteria
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.
Sites / Locations
- Site Reference ID/Investigator# 62887
- Site Reference ID/Investigator# 62824
- Site Reference ID/Investigator# 63710
- Site Reference ID/Investigator# 62884
- Site Reference ID/Investigator# 62826
- Site Reference ID/Investigator# 63703
- Site Reference ID/Investigator# 73913
- Site Reference ID/Investigator# 62886
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Active Comparator
Arm Label
ABT-652 6 mg
ABT-652 12 mg
ABT-652 12 mg - 18 mg
Placebo
Duloxetine
Arm Description
ABT-652 capsules - twice daily
ABT-652 capsules twice daily
ABT-652 capsules twice daily
Placebo capsules twice daily
Duloxetine capsules once daily
Outcomes
Primary Outcome Measures
24-hour Average Pain Score
Weekly mean of 24-hour average pain score measured by a 11-point Numeric Rating Scale completed on subject's daily diary.
Secondary Outcome Measures
Neuropathic Pain Symptom Inventory
Measures severity of common neuropathic pain qualities (burning, pressure, squeezing)
Patient Global Impression of Change
Captures the subject's evaluation of his/her overall general impression of feeling since beginning study medication
Brief Pain Inventory
Capture the subject's severity of pain and interference
Neuropathic Pain Impact on Quality of Life Questionnaire
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
Capture's the subject's mobility, self-care, usual activity, pain/discomfort and anxiety/depression
Full Information
NCT ID
NCT01579279
First Posted
April 16, 2012
Last Updated
September 24, 2013
Sponsor
AbbVie (prior sponsor, Abbott)
1. Study Identification
Unique Protocol Identification Number
NCT01579279
Brief Title
A Study Comparing the Efficacy and Safety of ABT-652 to Placebo in Subjects With Diabetic Neuropathic Pain
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Why Stopped
Study Stopped
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
A double blind, randomized, active- and placebo-controlled 13-week study. Duloxetine is added to evaluate assay sensitivity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathic Pain
Keywords
Diabetic neuropathic pain, Active controlled phase 2 study
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABT-652 6 mg
Arm Type
Experimental
Arm Description
ABT-652 capsules - twice daily
Arm Title
ABT-652 12 mg
Arm Type
Experimental
Arm Description
ABT-652 capsules twice daily
Arm Title
ABT-652 12 mg - 18 mg
Arm Type
Experimental
Arm Description
ABT-652 capsules twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules twice daily
Arm Title
Duloxetine
Arm Type
Active Comparator
Arm Description
Duloxetine capsules once daily
Intervention Type
Drug
Intervention Name(s)
ABT-652 6 mg
Intervention Description
6 mg capsules
Intervention Type
Drug
Intervention Name(s)
ABT-652 12 mg
Intervention Description
12 mg capsules
Intervention Type
Drug
Intervention Name(s)
ABT-652 12 mg - 18 mg
Intervention Description
12 mg - 18 mg capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Intervention Description
Duloxetine capsules
Primary Outcome Measure Information:
Title
24-hour Average Pain Score
Description
Weekly mean of 24-hour average pain score measured by a 11-point Numeric Rating Scale completed on subject's daily diary.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Neuropathic Pain Symptom Inventory
Description
Measures severity of common neuropathic pain qualities (burning, pressure, squeezing)
Time Frame
12 weeks
Title
Patient Global Impression of Change
Description
Captures the subject's evaluation of his/her overall general impression of feeling since beginning study medication
Time Frame
12 weeks
Title
Brief Pain Inventory
Description
Capture the subject's severity of pain and interference
Time Frame
12 weeks
Title
Neuropathic Pain Impact on Quality of Life Questionnaire
Description
Captures the subject's assessment of neuropathic pain and the effect it has on the quality of daily life
Time Frame
12 weeks
Title
EuroQuality of Life - 5 Dimension -5 Level
Description
Capture's the subject's mobility, self-care, usual activity, pain/discomfort and anxiety/depression
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfram Nothaft, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 62887
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Site Reference ID/Investigator# 62824
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Site Reference ID/Investigator# 63710
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Facility Name
Site Reference ID/Investigator# 62884
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Site Reference ID/Investigator# 62826
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Site Reference ID/Investigator# 63703
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Site Reference ID/Investigator# 73913
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
Site Reference ID/Investigator# 62886
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
12. IPD Sharing Statement
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A Study Comparing the Efficacy and Safety of ABT-652 to Placebo in Subjects With Diabetic Neuropathic Pain
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