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)
NCT ID: NCT02215252
Last Updated: 2017-05-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
141 participants
INTERVENTIONAL
2014-11-10
2015-09-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PF-05089771
PF-05089771 150 mg
PF-05089771 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
Placebo
Matched placebo for PF-05089771 150 mg and pregabalin 300 mg
Matched placebo for PF-05089771 150 mg twice daily and pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
Pregabalin
Pregabalin 300 mg
Pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
PF-05089771 + Pregabalin
PF-05089771 150 mg + Pregabalin 300 mg
PF-05089771 150 mg twice daily oral capsules with pregabalin 150 mg twice daily oral capsules. Treatment period = 4 weeks.
Interventions
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PF-05089771 150 mg
PF-05089771 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
Matched placebo for PF-05089771 150 mg and pregabalin 300 mg
Matched placebo for PF-05089771 150 mg twice daily and pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
Pregabalin 300 mg
Pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
PF-05089771 150 mg + Pregabalin 300 mg
PF-05089771 150 mg twice daily oral capsules with pregabalin 150 mg twice daily oral capsules. Treatment period = 4 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Internal Medicine Associates
Tullahoma, Tennessee, United States
Trinity Clinical Research, LLC
Tullahoma, Tennessee, United States
KRK Medical Research
Arlington, Texas, United States
Nerve and Muscle Center of Texas
Houston, Texas, United States
National Clinical Research - Norfolk, Inc
Norfolk, Virginia, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Rainier Clinical Research Center, Inc
Renton, Washington, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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DPN NAV1.7
Identifier Type: OTHER
Identifier Source: secondary_id
B3291026
Identifier Type: -
Identifier Source: org_study_id
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