Diabetic Neuropathic Pain Clinical Trial
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
| Verified date | January 2013 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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
| 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie (prior sponsor, Abbott) |
United States, Czech Republic, France, Germany, Italy, Spain, United Kingdom,
| 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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