A Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

NCT00548925 | Completed Phase 2

• 2 other identifiers: M10-0142007-001140-47
• Study Type: interventional
• Target: 124
• Locations: 7 countries
• Sites: 29

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

Conditions

Diabetic Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Weekly mean of 24-hour average pain score

  Change from Baseline to final

Secondary Outcomes (4)

• Pain improvement from Baseline to the final evaluation

  8-week

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

  8-week

• Global assessments of study drug and pain status

  8-week

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

  8-week

Study Arms (2)

1

EXPERIMENTAL

Drug: ABT-894

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

ABT-894 DRUG

6 mg BID tablets, 8 weeks of treatment

1

placebo DRUG

BID tablets, 8 weeks of treatment

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (29)

Site Reference ID/Investigator# 6614

Spring Valley, California, 91978, United States

Location

Site Reference ID/Investigator# 6617

Walnut Creek, California, 94598, United States

Location

Site Reference ID/Investigator# 6356

Hollywood, Florida, 33021, United States

Location

Site Reference ID/Investigator# 6615

Tampa, Florida, 33603, United States

Location

Site Reference ID/Investigator# 6358

Wellington, Florida, 33414, United States

Location

Site Reference ID/Investigator# 6609

St Louis, Missouri, 63141, United States

Location

Site Reference ID/Investigator# 7229

New Hyde Park, New York, 11042, United States

Location

Site Reference ID/Investigator# 6618

Charlotte, North Carolina, 28211, United States

Location

Site Reference ID/Investigator# 6607

Oklahoma City, Oklahoma, 73103, United States

Location

Site Reference ID/Investigator# 6575

Allentown, Pennsylvania, 18103, United States

Location

Site Reference ID/Investigator# 8179

San Antonio, Texas, 78229-4801, United States

Location

Site Reference ID/Investigator# 6616

San Antonio, Texas, 78229, United States

Location

Site Reference ID/Investigator# 5552

Hradec Králové, 500 03, Czechia

Location

Site Reference ID/Investigator# 5554

Olomouc, 77900, Czechia

Location

Site Reference ID/Investigator# 5553

Zlín, 760 01, Czechia

Location

Site Reference ID/Investigator# 9363

Corbeil-Essonnes, 91106, France

Location

Site Reference ID/Investigator# 5557

Limoges, 87042, France

Location

Site Reference ID/Investigator# 6238

Nevers, 58033, France

Location

Site Reference ID/Investigator# 6564

Bad Mergentheim, 97980, Germany

Location

Site Reference ID/Investigator# 11201

Berlin, 10115, Germany

Location

Site Reference ID/Investigator# 6234

Düsseldorf, 40225, Germany

Location

Site Reference ID/Investigator# 11202

Mainz, D - 55116, Germany

Location

Site Reference ID/Investigator# 7714

Munich, 80804, Germany

Location

Site Reference ID/Investigator# 5549

L’Aquila, 67100, Italy

Location

Site Reference ID/Investigator# 5558

Perugia, 06126, Italy

Location

Site Reference ID/Investigator# 6475

Granada, 18014, Spain

Location

Site Reference ID/Investigator# 7911

Sabadell, Barcelona, 8208, Spain

Location

Site Reference ID/Investigator# 5555

Birmingham, B29 6JD, United Kingdom

Location

Site Reference ID/Investigator# 7133

Sheffield, S5 7AU, United Kingdom

Location

MeSH Terms

Interventions

3-(5,6-dichloropyridin-3-yl)-3,6-diazabicyclo(3.2.0)heptane

Study Officials

• Rachel Duan, MD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2007
• First Posted: October 24, 2007
• Study Start: November 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 21, 2013

Record last verified: 2013-01

Locations

CZ (3); ES (2); FR (3); US (12); IT (2); GB (2); DE (5)