Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN)
NCT ID: NCT04146896
Last Updated: 2023-04-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
228 participants
INTERVENTIONAL
2019-11-12
2022-02-23
Brief Summary
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Detailed Description
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The study will be a 13- to 16-week study, including a 1- to 4-week Screening Period, followed by a 12- week double-blind, randomized, placebo-controlled Treatment Period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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NYX-2925
NYX-2925 50 mg
NYX-2925 50 mg
NYX-2925 administered orally
Placebo
Placebo
Placebo
Placebo administered orally
Interventions
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NYX-2925 50 mg
NYX-2925 administered orally
Placebo
Placebo administered orally
Eligibility Criteria
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Inclusion Criteria
* Subject has diabetic peripheral neuropathy of symmetrical nature in lower extremities for ≥4 years and reports at least moderate pain over the last week
* Stable diabetic and protocol allowed medication during the study
* Agrees to use highly effective birth control during the study
* Has not participated in an interventional study for at least 30 days and agrees not to participate in another interventional study during the study
Exclusion Criteria
* Current or historical serious medical conditions
* Prior participation in NYX-2925 clinical trial
18 Years
75 Years
ALL
No
Sponsors
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Worldwide Clinical Trials
OTHER
Aptinyx
INDUSTRY
Responsible Party
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Locations
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Aptinyx Clinical Site
Fresno, California, United States
Aptinyx Clinical Site
Irvine, California, United States
Aptinyx Clinical Site
Lomita, California, United States
Aptinyx Clinical Site
Los Angeles, California, United States
Aptinyx Clinical Site
Norco, California, United States
Aptinyx Clinical Site
Pomona, California, United States
Aptinyx Clinical Site
Santa Ana, California, United States
Aptinyx Clinical Site
Tustin, California, United States
Aptinyx Clinical Site
Brandon, Florida, United States
Aptinyx Clinical Site
Clearwater, Florida, United States
Aptinyx Clinical Site
Greenacres City, Florida, United States
Aptinyx Clinical Site
Miami, Florida, United States
Aptinyx Clinical Site
Miami, Florida, United States
Aptinyx Clinical Site
New Port Richey, Florida, United States
Aptinyx Clinical Site
Tampa, Florida, United States
Aptinyx Clinical Site
Tampa, Florida, United States
Aptinyx Clinical Site
Winter Haven, Florida, United States
Aptinyx Clinical Site
Winter Park, Florida, United States
Aptinyx Clinical Site
Decatur, Georgia, United States
Aptinyx Clinical Site
Marietta, Georgia, United States
Aptinyx Clinical Site
Blackfoot, Idaho, United States
Aptinyx Clinical Site
Flossmoor, Illinois, United States
Aptinyx Clinical Site
Rochester, Michigan, United States
Aptinyx Clinical Site
Hazelwood, Missouri, United States
Aptinyx Clinical Site
Las Vegas, Nevada, United States
Aptinyx Clinical Site
Brooklyn, New York, United States
Aptinyx Clinical Site
New York, New York, United States
Aptinyx Clinical Site
Rochester, New York, United States
Aptinyx Clinical Site
Greenville, North Carolina, United States
Aptinyx Clinical Site
Winston-Salem, North Carolina, United States
Aptinyx Clinical Site
Duncansville, Pennsylvania, United States
Aptinyx Clinical Site
Houston, Texas, United States
Aptinyx Clinical Site
Mesquite, Texas, United States
Aptinyx Clinical Site
Plano, Texas, United States
Aptinyx Clinical Site
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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NYX-2925-2008
Identifier Type: -
Identifier Source: org_study_id
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