A Multicenter Study Comparing the Analgesic Effects and Safety of ABT-639 Compared to Placebo in Subjects With Diabetic Neuropathic Pain

January 3, 2013 updated by: AbbVie (prior sponsor, Abbott)

A Multicenter, Randomized, Double-Blind, Placebo and Active Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-639 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
193

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Hradec Kralove, Czech Republic, 500 03
        • Site Reference ID/Investigator# 51425
      • Mor Ostrava, Czech Republic, 702 00
        • Site Reference ID/Investigator# 51426
      • Olomouc, Czech Republic, 77900
        • Site Reference ID/Investigator# 51424
      • Prague 10, Czech Republic, 100 00
        • Site Reference ID/Investigator# 51428
      • Prague 6, Czech Republic, 160 00
        • Site Reference ID/Investigator# 51423
      • Zlin, Czech Republic, 760 01
        • Site Reference ID/Investigator# 51427
  • France
      • Le Creusot, France, 71200
        • Site Reference ID/Investigator# 51924
      • Venissieux, France, 69200
        • Site Reference ID/Investigator# 51925
  • Germany
      • Berlin, Germany, 10115
        • Site Reference ID/Investigator# 51503
      • Duesseldorf, Germany, 40225
        • Site Reference ID/Investigator# 51642
      • Mainz, Germany, D - 55116
        • Site Reference ID/Investigator# 51502
      • Muenster, Germany, 48145
        • Site Reference ID/Investigator# 52346
  • Mexico
      • Guadalajara, Jal., Mexico, C.P. 44130
        • Site Reference ID/Investigator# 51505
      • Mexico D.F., Mexico, C.P. 11650
        • Site Reference ID/Investigator# 51504
      • Monterrey, N.L., Mexico, C.P. 64000
        • Site Reference ID/Investigator# 51522
      • Monterrey, N.L., Mexico, C.P. 64460
        • Site Reference ID/Investigator# 51506
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Site Reference ID/Investigator# 51807
    • California
      • Anaheim, California, United States, 92801
        • Site Reference ID/Investigator# 51946
      • Long Beach, California, United States, 90806
        • Site Reference ID/Investigator# 51468
      • Walnut Creek, California, United States, 94598
        • Site Reference ID/Investigator# 52744
    • Florida
      • Clearwater, Florida, United States, 33765
        • Site Reference ID/Investigator# 51079
      • Hialeah, Florida, United States, 33012
        • Site Reference ID/Investigator# 51076
      • Hollywood, Florida, United States, 33021
        • Site Reference ID/Investigator# 51945
      • Ocala, Florida, United States, 34471
        • Site Reference ID/Investigator# 51077
      • Orlando, Florida, United States, 32806
        • Site Reference ID/Investigator# 51078
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Site Reference ID/Investigator# 51804
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Site Reference ID/Investigator# 51263
      • St. Louis, Missouri, United States, 63141
        • Site Reference ID/Investigator# 51268
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Site Reference ID/Investigator# 51302
    • New York
      • Flushing, New York, United States, 11365
        • Site Reference ID/Investigator# 51271
    • Oregon
      • Portland, Oregon, United States, 97239
        • Site Reference ID/Investigator# 52743
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Site Reference ID/Investigator# 51806
      • Tipton, Pennsylvania, United States, 16684
        • Site Reference ID/Investigator# 51265
    • Texas
      • Dallas, Texas, United States, 75231
        • Site Reference ID/Investigator# 51548
    • Washington
      • Renton, Washington, United States, 98055
        • Site Reference ID/Investigator# 51269

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is between the ages of 18 to 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 an average score of greater than or equal to ( ≥) 4 on the 24 hour average pain score (0-10 numerical rating scale) collected over approximately 7 days prior to the Baseline Visit.

Exclusion Criteria:

  • Subject has clinically symptomatic neuropathic pain conditions that can not be distinguished from Diabetic Neuropathic Pain (DNP) or interfere with the pain assessments of DNP.
  • A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with DNP assessments or other functions.
  • Subject has clinically significant abnormalities in clinical laboratory tests.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ABT-639
ABT-639 twice daily for 6 weeks
Drug: ABT-639
ABT-639 Twice Daily for six weeks.
Active Comparator: pregabalin
pregabalin starting dose twice daily for week one then titrated up to maintenance dose twice daily for duration of the study
Drug: pregabalin
pregabalin starting dose twice daily for 1 week then titrated to maintenance dose twice daily for the remainder of the study.
Other Names:
  • Lyrica
Placebo Comparator: Placebo
Placebo twice daily for 6 weeks
Drug: Placebo
Placebo twice daily for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary
Time Frame: Weekly started at Baseline, Week 1, Week 2, Week 4, and Week 6 (End of Study)
Daily questions asked on a hand held diary
Weekly started at Baseline, Week 1, Week 2, Week 4, and Week 6 (End of Study)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient's Global Impression of Change
Time Frame: Week 2, Week 4 and Week 6 (End of Study)
Paper questionnaire
Week 2, Week 4 and Week 6 (End of Study)
Brief Pain Inventory (BPI) (short form) including Severity and Interference
Time Frame: At each visit up to Week 6 (end of Study)
Paper questionnaire
At each visit up to Week 6 (end of Study)
Neuropathic Pain Symptom Inventory (NPSI)
Time Frame: Baseline, Week 2, Week 4 and Week 6 (end of Study)
Paper questionnaire
Baseline, Week 2, Week 4 and Week 6 (end of Study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie (prior sponsor, Abbott)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M11-891
  • 2010-024359-99 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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