Study Stopped
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
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
1
1 country
8
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2012
Actual (reported)Study Completion
May 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
April 16, 2012
Actual (reported)April 17, 2012
Actual (reported)May 2012
Actual (reported)May 2012
Actual (reported)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.
12 weeks
Neuropathic Pain Symptom Inventory
12 weeks
Patient Global Impression of Change
12 weeks
Brief Pain Inventory
12 weeks
Neuropathic Pain Impact on Quality of Life Questionnaire
12 weeks
EuroQuality of Life - 5 Dimension -5 Level
12 weeks
ABT-652 capsules - twice daily
ABT-652 capsules twice daily
ABT-652 capsules twice daily
6 mg capsules
12 mg capsules
Site Reference ID/Investigator# 62887
Anaheim, California, 92801, United States
Site Reference ID/Investigator# 62824
Walnut Creek, California, 94598, United States
Site Reference ID/Investigator# 63710
Milford, Connecticut, 06460, United States
Site Reference ID/Investigator# 62884
DeLand, Florida, 32720, United States
Site Reference ID/Investigator# 62826
Orlando, Florida, 32806, United States
Site Reference ID/Investigator# 63703
Brockton, Massachusetts, 02301, United States
Site Reference ID/Investigator# 73913
Wolfram Nothaft, MD
AbbVie
1 participants (actual enrollment reported by the registry).
First Submitted
April 16, 2012
First Posted
April 17, 2012
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
Placebo capsules twice daily
Duloxetine capsules once daily
12 mg - 18 mg capsules
Placebo capsules
Duloxetine capsules
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Olive Branch, Mississippi, 38654, United States
Site Reference ID/Investigator# 62886
Dallas, Texas, 75231, United States
Primary Completion
May 2012
Actual (reported)Study Completion
May 2012
Actual (reported)Last Updated
September 26, 2013
Record last verified: 2013-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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