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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00548925
Other study ID # M10-014
Secondary ID 2007-001140-47
Status Completed
Phase Phase 2
First received October 22, 2007
Last updated January 11, 2013
Start date November 2007
Est. completion date December 2008

Study information

Verified date January 2013
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
ABT-894
6 mg BID tablets, 8 weeks of treatment
placebo
BID tablets, 8 weeks of treatment

Locations

Country Name City State
Czech Republic Site Reference ID/Investigator# 5552 Hradec Kralove
Czech Republic Site Reference ID/Investigator# 5554 Olomouc
Czech Republic Site Reference ID/Investigator# 5553 Zlin
France Site Reference ID/Investigator# 9363 Corbeil Essonnes
France Site Reference ID/Investigator# 5557 Limoges
France Site Reference ID/Investigator# 6238 Nevers
Germany Site Reference ID/Investigator# 6564 Bad Mergentheim
Germany Site Reference ID/Investigator# 11201 Berlin
Germany Site Reference ID/Investigator# 6234 Duesseldorf
Germany Site Reference ID/Investigator# 11202 Mainz
Germany Site Reference ID/Investigator# 7714 Munich
Italy Site Reference ID/Investigator# 5549 L'Aquila
Italy Site Reference ID/Investigator# 5558 Perugia
Spain Site Reference ID/Investigator# 6475 Granada
Spain Site Reference ID/Investigator# 7911 Sabadell, Barcelona
United Kingdom Site Reference ID/Investigator# 5555 Birmingham
United Kingdom Site Reference ID/Investigator# 7133 Sheffield
United States Site Reference ID/Investigator# 6575 Allentown Pennsylvania
United States Site Reference ID/Investigator# 6618 Charlotte North Carolina
United States Site Reference ID/Investigator# 6356 Hollywood Florida
United States Site Reference ID/Investigator# 7229 New Hyde Park New York
United States Site Reference ID/Investigator# 6607 Oklahoma City Oklahoma
United States Site Reference ID/Investigator# 6616 San Antonio Texas
United States Site Reference ID/Investigator# 8179 San Antonio Texas
United States Site Reference ID/Investigator# 6614 Spring Valley California
United States Site Reference ID/Investigator# 6609 St. Louis Missouri
United States Site Reference ID/Investigator# 6615 Tampa Florida
United States Site Reference ID/Investigator# 6617 Walnut Creek California
United States Site Reference ID/Investigator# 6358 Wellington Florida

Sponsors (1)

Lead Sponsor Collaborator
AbbVie (prior sponsor, Abbott)

Countries where clinical trial is conducted

United States,  Czech Republic,  France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weekly mean of 24-hour average pain score Change from Baseline to final No
Secondary Pain improvement from Baseline to the final evaluation 8-week No
Secondary Weekly mean of 24-hour worst pain severity; weekly average night pain and morning pain 8-week No
Secondary Global assessments of study drug and pain status 8-week No
Secondary Short-Form McGill Pain Questionnaire (SF-MPQ), Neuropathic Pain Scale (NPS) 8-week No
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