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

NCT ID: NCT01579279

Last Updated: 2013-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-05-31

Brief Summary

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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

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

Conditions

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Diabetic Neuropathic Pain

Keywords

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Diabetic neuropathic pain Active controlled phase 2 study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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ABT-652 6 mg

ABT-652 capsules - twice daily

Group Type EXPERIMENTAL

ABT-652 6 mg

Intervention Type DRUG

6 mg capsules

ABT-652 12 mg

ABT-652 capsules twice daily

Group Type EXPERIMENTAL

ABT-652 12 mg

Intervention Type DRUG

12 mg capsules

ABT-652 12 mg - 18 mg

ABT-652 capsules twice daily

Group Type EXPERIMENTAL

ABT-652 12 mg - 18 mg

Intervention Type DRUG

12 mg - 18 mg capsules

Placebo

Placebo capsules twice daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsules

Duloxetine

Duloxetine capsules once daily

Group Type ACTIVE_COMPARATOR

Duloxetine

Intervention Type DRUG

Duloxetine capsules

Interventions

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ABT-652 6 mg

6 mg capsules

Intervention Type DRUG

ABT-652 12 mg

12 mg capsules

Intervention Type DRUG

ABT-652 12 mg - 18 mg

12 mg - 18 mg capsules

Intervention Type DRUG

Placebo

Placebo capsules

Intervention Type DRUG

Duloxetine

Duloxetine capsules

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wolfram Nothaft, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

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Site Reference ID/Investigator# 62887

Anaheim, California, United States

Site Status

Site Reference ID/Investigator# 62824

Walnut Creek, California, United States

Site Status

Site Reference ID/Investigator# 63710

Milford, Connecticut, United States

Site Status

Site Reference ID/Investigator# 62884

DeLand, Florida, United States

Site Status

Site Reference ID/Investigator# 62826

Orlando, Florida, United States

Site Status

Site Reference ID/Investigator# 63703

Brockton, Massachusetts, United States

Site Status

Site Reference ID/Investigator# 73913

Olive Branch, Mississippi, United States

Site Status

Site Reference ID/Investigator# 62886

Dallas, Texas, United States

Site Status

Countries

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Puerto Rico United States

Other Identifiers

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2011-003939-56

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M11-210

Identifier Type: -

Identifier Source: org_study_id