Back to results

A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

Primary Purpose

Diabetic Neuropathic Pain

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

ABT-894

placebo

About this trial

This is an interventional treatment trial for Diabetic Neuropathic Pain

Eligibility Criteria

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

Inclusion Criteria:

Males and females, age 18 to 75
If female, must be of non-childbearing potential or practicing birth control
Has diabetes mellitus (Type 1 or 2) and a diagnosis of painful distal symmetric diabetic polyneuropathy
Has had pain from distal symmetric diabetic polyneuropathy for a minimum of 6 months
Must be willing to washout of all analgesic medications prior to entry into the study

Exclusion Criteria:

Has other conditions that may cause pain
Currently receiving analgesic medications for conditions other than diabetic neuropathic pain
Has a history of certain psychiatric diseases
Has a history of certain heart or cardiovascular conditions
Has any clinically significant recent infection, injury, or illness
Current participation in another clinical study or participation within the past 30 days
Is incapacitated, bedridden or confined to a wheelchair
Is pregnant and/or breastfeeding
Previous participation in this study or any other study with this investigational product.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Weekly mean of 24-hour average pain score

Secondary Outcome Measures

Pain improvement from Baseline to the final evaluation

Weekly mean of 24-hour worst pain severity; weekly average night pain and morning pain

Global assessments of study drug and pain status

Short-Form McGill Pain Questionnaire (SF-MPQ), Neuropathic Pain Scale (NPS)

Full Information

NCT ID

NCT00548925

First Posted

October 22, 2007

Last Updated

January 11, 2013

Sponsor

AbbVie (prior sponsor, Abbott)

1. Study Identification

Unique Protocol Identification Number

NCT00548925

Brief Title

A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

Official Title

A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ABT-894 Versus 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

November 2007 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of a 6 mg twice a day dose of an investigational product in subjects with diabetic neuropathy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Neuropathic Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

124 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

ABT-894

Intervention Description

6 mg BID tablets, 8 weeks of treatment

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

BID tablets, 8 weeks of treatment

Primary Outcome Measure Information:

Title

Weekly mean of 24-hour average pain score

Time Frame

Change from Baseline to final

Secondary Outcome Measure Information:

Title

Pain improvement from Baseline to the final evaluation

Time Frame

8-week

Title

Weekly mean of 24-hour worst pain severity; weekly average night pain and morning pain

Time Frame

8-week

Title

Global assessments of study drug and pain status

Time Frame

8-week

Title

Short-Form McGill Pain Questionnaire (SF-MPQ), Neuropathic Pain Scale (NPS)

Time Frame

8-week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males and females, age 18 to 75 If female, must be of non-childbearing potential or practicing birth control Has diabetes mellitus (Type 1 or 2) and a diagnosis of painful distal symmetric diabetic polyneuropathy Has had pain from distal symmetric diabetic polyneuropathy for a minimum of 6 months Must be willing to washout of all analgesic medications prior to entry into the study Exclusion Criteria: Has other conditions that may cause pain Currently receiving analgesic medications for conditions other than diabetic neuropathic pain Has a history of certain psychiatric diseases Has a history of certain heart or cardiovascular conditions Has any clinically significant recent infection, injury, or illness Current participation in another clinical study or participation within the past 30 days Is incapacitated, bedridden or confined to a wheelchair Is pregnant and/or breastfeeding Previous participation in this study or any other study with this investigational product.

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# 6614

City

Spring Valley

State/Province

California

ZIP/Postal Code

91978

Country

United States

Facility Name

Site Reference ID/Investigator# 6617

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Site Reference ID/Investigator# 6356

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

Site Reference ID/Investigator# 6615

City

Tampa

State/Province

Florida

ZIP/Postal Code

33603

Country

United States

Facility Name

Site Reference ID/Investigator# 6358

City

Wellington

State/Province

Florida

ZIP/Postal Code

33414

Country

United States

Facility Name

Site Reference ID/Investigator# 6609

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Site Reference ID/Investigator# 7229

City

New Hyde Park

State/Province

New York

ZIP/Postal Code

11042

Country

United States

Facility Name

Site Reference ID/Investigator# 6618

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28211

Country

United States

Facility Name

Site Reference ID/Investigator# 6607

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Site Reference ID/Investigator# 6575

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18103

Country

United States

Facility Name

Site Reference ID/Investigator# 8179

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229-4801

Country

United States

Facility Name

Site Reference ID/Investigator# 6616

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Site Reference ID/Investigator# 5552

City

Hradec Kralove

ZIP/Postal Code

500 03

Country

Czech Republic

Facility Name

Site Reference ID/Investigator# 5554

City

Olomouc

ZIP/Postal Code

77900

Country

Czech Republic

Facility Name

Site Reference ID/Investigator# 5553

City

Zlin

ZIP/Postal Code

760 01

Country

Czech Republic

Facility Name

Site Reference ID/Investigator# 9363

City

Corbeil Essonnes

ZIP/Postal Code

91106

Country

France

Facility Name

Site Reference ID/Investigator# 5557

City

Limoges

ZIP/Postal Code

87042

Country

France

Facility Name

Site Reference ID/Investigator# 6238

City

Nevers

ZIP/Postal Code

58033

Country

France

Facility Name

Site Reference ID/Investigator# 6564

City

Bad Mergentheim

ZIP/Postal Code

97980

Country

Germany

Facility Name

Site Reference ID/Investigator# 11201

City

Berlin

ZIP/Postal Code

10115

Country

Germany

Facility Name

Site Reference ID/Investigator# 6234

City

Duesseldorf

ZIP/Postal Code

40225

Country

Germany

Facility Name

Site Reference ID/Investigator# 11202

City

Mainz

ZIP/Postal Code

D - 55116

Country

Germany

Facility Name

Site Reference ID/Investigator# 7714

City

Munich

ZIP/Postal Code

80804

Country

Germany

Facility Name

Site Reference ID/Investigator# 5549

City

L'Aquila

ZIP/Postal Code

67100

Country

Italy

Facility Name

Site Reference ID/Investigator# 5558

City

Perugia

ZIP/Postal Code

06126

Country

Italy

Facility Name

Site Reference ID/Investigator# 6475

City

Granada

ZIP/Postal Code

18014

Country

Spain

Facility Name

Site Reference ID/Investigator# 7911

City

Sabadell, Barcelona

ZIP/Postal Code

8208

Country

Spain

Facility Name

Site Reference ID/Investigator# 5555

City

Birmingham

ZIP/Postal Code

B29 6JD

Country

United Kingdom

Facility Name

Site Reference ID/Investigator# 7133

City

Sheffield

ZIP/Postal Code

S5 7AU

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

We'll reach out to this number within 24 hrs

A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

Diabetic Neuropathic Pain

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial