Diabetic Neuropathic Pain Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Placebo and Active Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-639 to Placebo in Subjects With Diabetic Neuropathic Pain
People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.
| Status | Completed |
| Enrollment | 193 |
| Est. completion date | October 2011 |
| Est. primary completion date | October 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Subject is between the ages of 18 to 75 years with a diagnosis of diabetes mellitus and must have a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months. - Subject must have an average score of greater than or equal to ( =) 4 on the 24 hour average pain score (0-10 numerical rating scale) collected over approximately 7 days prior to the Baseline Visit. Exclusion Criteria: - Subject has clinically symptomatic neuropathic pain conditions that can not be distinguished from Diabetic Neuropathic Pain (DNP) or interfere with the pain assessments of DNP. - A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with DNP assessments or other functions. - Subject has clinically significant abnormalities in clinical laboratory tests. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Czech Republic | Site Reference ID/Investigator# 51425 | Hradec Kralove | |
| Czech Republic | Site Reference ID/Investigator# 51426 | Mor Ostrava | |
| Czech Republic | Site Reference ID/Investigator# 51424 | Olomouc | |
| Czech Republic | Site Reference ID/Investigator# 51428 | Prague 10 | |
| Czech Republic | Site Reference ID/Investigator# 51423 | Prague 6 | |
| Czech Republic | Site Reference ID/Investigator# 51427 | Zlin | |
| France | Site Reference ID/Investigator# 51924 | Le Creusot | |
| France | Site Reference ID/Investigator# 51925 | Venissieux | |
| Germany | Site Reference ID/Investigator# 51503 | Berlin | |
| Germany | Site Reference ID/Investigator# 51642 | Duesseldorf | |
| Germany | Site Reference ID/Investigator# 51502 | Mainz | |
| Germany | Site Reference ID/Investigator# 52346 | Muenster | |
| Mexico | Site Reference ID/Investigator# 51505 | Guadalajara, Jal. | |
| Mexico | Site Reference ID/Investigator# 51504 | Mexico D.F. | |
| Mexico | Site Reference ID/Investigator# 51506 | Monterrey, N.L. | |
| Mexico | Site Reference ID/Investigator# 51522 | Monterrey, N.L. | |
| United States | Site Reference ID/Investigator# 51806 | Altoona | Pennsylvania |
| United States | Site Reference ID/Investigator# 51946 | Anaheim | California |
| United States | Site Reference ID/Investigator# 51804 | Brockton | Massachusetts |
| United States | Site Reference ID/Investigator# 51079 | Clearwater | Florida |
| United States | Site Reference ID/Investigator# 51548 | Dallas | Texas |
| United States | Site Reference ID/Investigator# 51271 | Flushing | New York |
| United States | Site Reference ID/Investigator# 51076 | Hialeah | Florida |
| United States | Site Reference ID/Investigator# 51945 | Hollywood | Florida |
| United States | Site Reference ID/Investigator# 51807 | Little Rock | Arkansas |
| United States | Site Reference ID/Investigator# 51468 | Long Beach | California |
| United States | Site Reference ID/Investigator# 51077 | Ocala | Florida |
| United States | Site Reference ID/Investigator# 51302 | Omaha | Nebraska |
| United States | Site Reference ID/Investigator# 51078 | Orlando | Florida |
| United States | Site Reference ID/Investigator# 52743 | Portland | Oregon |
| United States | Site Reference ID/Investigator# 51269 | Renton | Washington |
| United States | Site Reference ID/Investigator# 51263 | St. Louis | Missouri |
| United States | Site Reference ID/Investigator# 51268 | St. Louis | Missouri |
| United States | Site Reference ID/Investigator# 51265 | Tipton | Pennsylvania |
| United States | Site Reference ID/Investigator# 52744 | Walnut Creek | California |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie (prior sponsor, Abbott) |
United States, Czech Republic, France, Germany, Mexico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary | Daily questions asked on a hand held diary | Weekly started at Baseline, Week 1, Week 2, Week 4, and Week 6 (End of Study) | No |
| Secondary | Patient's Global Impression of Change | Paper questionnaire | Week 2, Week 4 and Week 6 (End of Study) | No |
| Secondary | Brief Pain Inventory (BPI) (short form) including Severity and Interference | Paper questionnaire | At each visit up to Week 6 (end of Study) | No |
| Secondary | Neuropathic Pain Symptom Inventory (NPSI) | Paper questionnaire | Baseline, Week 2, Week 4 and Week 6 (end of Study) | No |
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