Clinical trial NCT00548925: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Neuropathic Pain
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2007-10-24
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Weekly mean of 24-hour average pain score
timeFrame: Change from Baseline to final
Secondary outcomes:
measure: Pain improvement from Baseline to the final evaluation
timeFrame: 8-week
measure: Weekly mean of 24-hour worst pain severity; weekly average night pain and morning pain
timeFrame: 8-week
measure: Global assessments of study drug and pain status
timeFrame: 8-week
measure: Short-Form McGill Pain Questionnaire (SF-MPQ), Neuropathic Pain Scale (NPS)
timeFrame: 8-week
Other outcomes:
Locations:
city: Spring Valley
country: United States
facility: Site Reference ID/Investigator# 6614
state: California
city: Walnut Creek
country: United States
facility: Site Reference ID/Investigator# 6617
state: California
city: Hollywood
country: United States
facility: Site Reference ID/Investigator# 6356
state: Florida
city: Tampa
country: United States
facility: Site Reference ID/Investigator# 6615
state: Florida
city: Wellington
country: United States
facility: Site Reference ID/Investigator# 6358
state: Florida
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 6609
state: Missouri
city: New Hyde Park
country: United States
facility: Site Reference ID/Investigator# 7229
state: New York
city: Charlotte
country: United States
facility: Site Reference ID/Investigator# 6618
state: North Carolina
city: Oklahoma City
country: United States
facility: Site Reference ID/Investigator# 6607
state: Oklahoma
city: Allentown
country: United States
facility: Site Reference ID/Investigator# 6575
state: Pennsylvania
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 8179
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 6616
state: Texas
city: Hradec Kralove
country: Czech Republic
facility: Site Reference ID/Investigator# 5552
city: Olomouc
country: Czech Republic
facility: Site Reference ID/Investigator# 5554
city: Zlin
country: Czech Republic
facility: Site Reference ID/Investigator# 5553
city: Corbeil Essonnes
country: France
facility: Site Reference ID/Investigator# 9363
city: Limoges
country: France
facility: Site Reference ID/Investigator# 5557
city: Nevers
country: France
facility: Site Reference ID/Investigator# 6238
city: Bad Mergentheim
country: Germany
facility: Site Reference ID/Investigator# 6564
city: Berlin
country: Germany
facility: Site Reference ID/Investigator# 11201
city: Duesseldorf
country: Germany
facility: Site Reference ID/Investigator# 6234
city: Mainz
country: Germany
facility: Site Reference ID/Investigator# 11202
city: Munich
country: Germany
facility: Site Reference ID/Investigator# 7714
city: L'Aquila
country: Italy
facility: Site Reference ID/Investigator# 5549
city: Perugia
country: Italy
facility: Site Reference ID/Investigator# 5558
city: Granada
country: Spain
facility: Site Reference ID/Investigator# 6475
city: Sabadell, Barcelona
country: Spain
facility: Site Reference ID/Investigator# 7911
city: Birmingham
country: United Kingdom
facility: Site Reference ID/Investigator# 5555
city: Sheffield
country: United Kingdom
facility: Site Reference ID/Investigator# 7133
Study officials:
affiliation: AbbVie
name: Rachel Duan, MD
role: STUDY_DIRECTOR
References: