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)

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Neuropathy, Painful

In brief

The purpose of this study is to evaluate the efficacy and safety of PF-05089771 as a monotherapy and as an add-on to pregabalin for the treatment of painful diabetic peripheral neuropathy (DPN)

Key facts

Study ID

NCT02215252

Run by

Pfizer

People needed

141

Starts

2014-11-10

Expected to finish

2015-09-28

Last updated by the study team

2017-05-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Research Consortium Arizona — Phoenix, Arizona, United States
• Arizona Research Center — Phoenix, Arizona, United States
• Neuro-Pain Medical Center — Fresno, California, United States
• Meridien Research — Bradenton, Florida, United States
• PAB Clinical Research — Brandon, Florida, United States
• Pulmonary Associates of Brandon (PAB) — Brandon, Florida, United States
• Meridien Research — Brooksville, Florida, United States
• Clinical Physiology Associates — Fort Myers, Florida, United States
• MD Clinical — Hallandale, Florida, United States
• Meridien Research — Lakeland, Florida, United States
• Family Care Specialists — Ocala, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Oviedo Medical Research, LLC — Oviedo, Florida, United States
• Meridien Research — St. Petersburg, Florida, United States
• Meridien Research — Tampa, Florida, United States
• Metabolic Research Institute, Inc — West Palm Beach, Florida, United States
• Columbus Regional Research Institute — Columbus, Georgia, United States
• Clinical Research Advantage, Inc — Evansville, Indiana, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Novex Clinical Research, LLC — New Bedford, Massachusetts, United States
• Beacon Clinical Research, LLC — Quincy, Massachusetts, United States
• Michigan Head Pain and Neurological Institute — Ann Arbor, Michigan, United States
• Clinical Research Consortium — Las Vegas, Nevada, United States
• The Medical Research Network, LLC — New York, New York, United States
• New Phase Research and Development — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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