Clinical trial NCT01579279: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetic Neuropathic Pain
Keywords: Diabetic neuropathic pain
Active controlled phase 2 study
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-04-17
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 24-hour Average Pain Score
timeFrame: 12 weeks
Secondary outcomes:
measure: Neuropathic Pain Symptom Inventory
timeFrame: 12 weeks
measure: Patient Global Impression of Change
timeFrame: 12 weeks
measure: Brief Pain Inventory
timeFrame: 12 weeks
measure: Neuropathic Pain Impact on Quality of Life Questionnaire
timeFrame: 12 weeks
measure: EuroQuality of Life - 5 Dimension -5 Level
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Site Reference ID/Investigator# 62887
state: California
city: Walnut Creek
country: United States
facility: Site Reference ID/Investigator# 62824
state: California
city: Milford
country: United States
facility: Site Reference ID/Investigator# 63710
state: Connecticut
city: DeLand
country: United States
facility: Site Reference ID/Investigator# 62884
state: Florida
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 62826
state: Florida
city: Brockton
country: United States
facility: Site Reference ID/Investigator# 63703
state: Massachusetts
city: Olive Branch
country: United States
facility: Site Reference ID/Investigator# 73913
state: Mississippi
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 62886
state: Texas
Study officials:
affiliation: AbbVie
name: Wolfram Nothaft, MD
role: STUDY_DIRECTOR
References: