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

Primary Purpose

Diabetic Neuropathic Pain

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ABT-639
pregabalin
Placebo
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathic Pain focused on measuring Diabetic Asymmetric Polyneuropathy, Symmetric Diabetic Proximal Motor Neuropathy, Diabetic Mononeuropathy Simplex,, Diabetic Autonomic Neuropathy,, Diabetic Amyotrophy, Mononeuropathy, Diabetic Neuropathy, Asymmetric Diabetic Proximal Motor Neuropathy, Diabetic Polyneuropathy, Painful, Diabetic Mononeuropathy, Neuralgia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site Reference ID/Investigator# 51807
  • Site Reference ID/Investigator# 51946
  • Site Reference ID/Investigator# 51468
  • Site Reference ID/Investigator# 52744
  • Site Reference ID/Investigator# 51079
  • Site Reference ID/Investigator# 51076
  • Site Reference ID/Investigator# 51945
  • Site Reference ID/Investigator# 51077
  • Site Reference ID/Investigator# 51078
  • Site Reference ID/Investigator# 51804
  • Site Reference ID/Investigator# 51263
  • Site Reference ID/Investigator# 51268
  • Site Reference ID/Investigator# 51302
  • Site Reference ID/Investigator# 51271
  • Site Reference ID/Investigator# 52743
  • Site Reference ID/Investigator# 51806
  • Site Reference ID/Investigator# 51265
  • Site Reference ID/Investigator# 51548
  • Site Reference ID/Investigator# 51269
  • Site Reference ID/Investigator# 51425
  • Site Reference ID/Investigator# 51426
  • Site Reference ID/Investigator# 51424
  • Site Reference ID/Investigator# 51428
  • Site Reference ID/Investigator# 51423
  • Site Reference ID/Investigator# 51427
  • Site Reference ID/Investigator# 51924
  • Site Reference ID/Investigator# 51925
  • Site Reference ID/Investigator# 51503
  • Site Reference ID/Investigator# 51642
  • Site Reference ID/Investigator# 51502
  • Site Reference ID/Investigator# 52346
  • Site Reference ID/Investigator# 51505
  • Site Reference ID/Investigator# 51504
  • Site Reference ID/Investigator# 51522
  • Site Reference ID/Investigator# 51506

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

ABT-639

pregabalin

Placebo

Arm Description

ABT-639 twice daily for 6 weeks

pregabalin starting dose twice daily for week one then titrated up to maintenance dose twice daily for duration of the study

Placebo twice daily for 6 weeks

Outcomes

Primary Outcome Measures

A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary
Daily questions asked on a hand held diary

Secondary Outcome Measures

Patient's Global Impression of Change
Paper questionnaire
Brief Pain Inventory (BPI) (short form) including Severity and Interference
Paper questionnaire
Neuropathic Pain Symptom Inventory (NPSI)
Paper questionnaire

Full Information

First Posted
April 28, 2011
Last Updated
January 3, 2013
Sponsor
AbbVie (prior sponsor, Abbott)
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1. Study Identification

Unique Protocol Identification Number
NCT01345045
Brief Title
A Multicenter Study Comparing the Analgesic Effects and Safety of ABT-639 Compared 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-639 to Placebo in Subjects With Diabetic Neuropathic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathic Pain
Keywords
Diabetic Asymmetric Polyneuropathy, Symmetric Diabetic Proximal Motor Neuropathy, Diabetic Mononeuropathy Simplex,, Diabetic Autonomic Neuropathy,, Diabetic Amyotrophy, Mononeuropathy, Diabetic Neuropathy, Asymmetric Diabetic Proximal Motor Neuropathy, Diabetic Polyneuropathy, Painful, Diabetic Mononeuropathy, Neuralgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
193 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABT-639
Arm Type
Experimental
Arm Description
ABT-639 twice daily for 6 weeks
Arm Title
pregabalin
Arm Type
Active Comparator
Arm Description
pregabalin starting dose twice daily for week one then titrated up to maintenance dose twice daily for duration of the study
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo twice daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
ABT-639
Intervention Description
ABT-639 Twice Daily for six weeks.
Intervention Type
Drug
Intervention Name(s)
pregabalin
Other Intervention Name(s)
Lyrica
Intervention Description
pregabalin starting dose twice daily for 1 week then titrated to maintenance dose twice daily for the remainder of the study.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo twice daily for 6 weeks.
Primary Outcome Measure Information:
Title
A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary
Description
Daily questions asked on a hand held diary
Time Frame
Weekly started at Baseline, Week 1, Week 2, Week 4, and Week 6 (End of Study)
Secondary Outcome Measure Information:
Title
Patient's Global Impression of Change
Description
Paper questionnaire
Time Frame
Week 2, Week 4 and Week 6 (End of Study)
Title
Brief Pain Inventory (BPI) (short form) including Severity and Interference
Description
Paper questionnaire
Time Frame
At each visit up to Week 6 (end of Study)
Title
Neuropathic Pain Symptom Inventory (NPSI)
Description
Paper questionnaire
Time Frame
Baseline, Week 2, Week 4 and Week 6 (end of Study)

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
26067585
Citation
Ziegler D, Duan WR, An G, Thomas JW, Nothaft W. A randomized double-blind, placebo-, and active-controlled study of T-type calcium channel blocker ABT-639 in patients with diabetic peripheral neuropathic pain. Pain. 2015 Oct;156(10):2013-2020. doi: 10.1097/j.pain.0000000000000263.
Results Reference
derived

Learn more about this trial

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

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