A Clinical Trial To Evaluate PF-05089771 On Its Own And As An Add-On Therapy To Pregabalin (Lyrica) For The Treatment Of Pain Due To Diabetic Peripheral Neuropathy (DPN)
Launched by PFIZER · Aug 11, 2014
Trial Information
Current as of June 14, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Men and women aged 18 years to 80 years.
- • Diagnosis of Type 2 diabetes mellitlus (T2DM) with current glycosylated hemoglobin A1c (HbA1c) levels of ≤ 11% at Screening and on a stable antidiabetic medication regimen for at least 30 days prior to randomization.
- • Presence of ongoing pain due to DPN for at least 6 months.
- • Willing to discontinue protocol-specified prohibited pain medications for DPN throughout the duration of the study.
- Exclusion Criteria:
- • Painful neuropathies or painful conditions other than DPN that may confound evaluation of pain due to DPN during the study.
- • Subjects who have failed previously on pregabalin (at the recommended label dose and for adequate duration) due to lack of efficacy.
- • Subjects with any clinically significant medical or psychiatric conditions or clinically significant laboratory test abnormalities.
- • Pregnant women, lactating mothers, men with partners currently pregnant, women suspected of being pregnant, and women who wish to be pregnant during the course of the clinical study.
About Pfizer
Pfizer Inc. is a global leader in biopharmaceutical innovation, dedicated to discovering, developing, and delivering advanced therapies that enhance patient outcomes across a wide range of medical conditions. With a rich history of scientific research and a commitment to quality, Pfizer focuses on areas such as oncology, immunology, cardiology, and rare diseases. The company leverages cutting-edge technology and collaborates with healthcare professionals, regulatory bodies, and academic institutions to conduct rigorous clinical trials that ensure the safety and efficacy of its products. Pfizer's mission is to bring breakthroughs that change patients' lives, exemplifying its commitment to health and wellness worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Phoenix, Arizona, United States
Ocala, Florida, United States
Brandon, Florida, United States
St. Petersburg, Florida, United States
Norfolk, Virginia, United States
Ann Arbor, Michigan, United States
Fresno, California, United States
Fort Myers, Florida, United States
New Bedford, Massachusetts, United States
Houston, Texas, United States
Renton, Washington, United States
Brooksville, Florida, United States
Las Vegas, Nevada, United States
New York, New York, United States
Bradenton, Florida, United States
Tullahoma, Tennessee, United States
Arlington, Texas, United States
Ocala, Florida, United States
Columbus, Georgia, United States
Knoxville, Tennessee, United States
Lakeland, Florida, United States
Tampa, Florida, United States
Norfolk, Virginia, United States
Quincy, Massachusetts, United States
Oviedo, Florida, United States
Phoenix, Arizona, United States
Brandon, Florida, United States
Hallandale, Florida, United States
West Palm Beach, Florida, United States
Evansville, Indiana, United States
Tullahoma, Tennessee, United States
Patients applied
Trial Officials
Pfizer CT.gov Call Center
Study Director
Pfizer
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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