A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip
Public ClinicalTrials.gov record NCT03161093. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Randomized, Double-blind, Multi-dose, Placebo and Naproxen-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients With Pain Due to Osteoarthritis of the Knee or Hip
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of the study is to evaluate the efficacy of fasinumab compared with placebo, when administered for up to 16 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip. The secondary objectives of the study are: 1. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip 2. To evaluate the efficacy of fasinumab compared with placebo, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip 3. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip 4. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 52 weeks in patients with pain due to OA of the knee or hip 5. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 104 weeks in patients with pain due to OA of the knee or hip 6. To evaluate the pharmacokinetic (PK) profile of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks 7. To evaluate the PK profile of fasimumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks 8. To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks 9. To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks 10. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip
Study identification
- NCT ID
- NCT03161093
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 3,307 participants
Conditions and interventions
Conditions
Interventions
- Fasinumab Drug
- Naproxen Drug
- Fasinumab-matching placebo Drug
- Naproxen-matching placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 17, 2017 (Actual)
- Primary completion
- Sep 9, 2019 (Actual)
- Completion
- Aug 27, 2021 (Actual)
- Last update posted
- Nov 14, 2022
2017 – 2021
United States locations
- U.S. sites
- 58
- U.S. states
- 24
- U.S. cities
- 53
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Arthritis & Rheumatology Research, PLLC | Mesa | Arizona | 85210 | — |
| Arizona Research Center | Phoenix | Arizona | 85053 | — |
| Tucson Orthopaedic Research Center | Tucson | Arizona | 85712 | — |
| Baptist Health Center for Clinical Research | Little Rock | Arkansas | 72205 | — |
| Medvin Clinical Research | Covina | California | 91722 | — |
| TriWest Research Associates, LLC | El Cajon | California | 92020 | — |
| BioSolutions Clinical Research | La Mesa | California | 91942 | — |
| Pacific Arthritis Care Center | Los Angeles | California | 90045 | — |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | — |
| Artemis Clinical Research | San Marcos | California | 92078 | — |
| Lynn Institute of Denver | Aurora | Colorado | 80012 | — |
| Lynn Institute of the Rockies | Colorado Springs | Colorado | 80920 | — |
| Panorama Orthopedics & Spine Center | Golden | Colorado | 80401 | — |
| Arthritis and Rheumatic Disease Specialties | Aventura | Florida | 33180 | — |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | — |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | — |
| Sensible Healthcare | Ocoee | Florida | 34761 | — |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | — |
| Jewett Orthopaedic Clinic | Orlando | Florida | 32825 | — |
| Lovelace Scientific Resources | Venice | Florida | 34292 | — |
| Meridian Clinical Research | Savannah | Georgia | 31406 | — |
| Advanced Clinical Research | Meridian | Idaho | 83642 | — |
| Medex Healthcare Research, Inc. | Chicago | Illinois | 60602 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Healthcare Research Network II, LLC | Flossmoor | Illinois | 60422 | — |
| Integrated Clinical Trial Services, Inc. | West Des Moines | Iowa | 50265 | — |
| Klein & Associates, MD PA | Cumberland | Maryland | 21502 | — |
| Klein & Associates, MD, PA | Hagerstown | Maryland | 21740 | — |
| The Center for Rheumatology and Bone Research | Wheaton | Maryland | 20902 | — |
| Clinical Pharmacology Study Group | Worcester | Massachusetts | 01605 | — |
| The Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | — |
| Medex Healthcare Research, Inc. | St Louis | Missouri | 63117 | — |
| Sundance Clinical Research, LLC | St Louis | Missouri | 63141 | — |
| Physician Research Collaboration, LLC | Lincoln | Nebraska | 68516 | — |
| Lovelace Scientific Resources, Inc. | Albuquerque | New Mexico | 87108 | — |
| United Medical Associates | Binghamton | New York | 13901 | — |
| Regional Clinical Research, Inc. | Endwell | New York | 13760 | — |
| Medex Healthcare Research | New York | New York | 10036 | — |
| Buffalo Rheumatology and Medicine, PLLC | Orchard Park | New York | 14127 | — |
| Orchard Park Family Practice | Orchard Park | New York | 14127 | — |
| PMG Research of Raleigh, LLC d/b/a PMG Research of Cary | Cary | North Carolina | 27518 | — |
| DJL Clinical Research, PLLC | Charlotte | North Carolina | 28210 | — |
| Hickory Family Practice Associates | Hickory | North Carolina | 28601 | — |
| Peters Medical Research LLC | High Point | North Carolina | 27262 | — |
| PMG Research of Salisbury, LLC | Salisbury | North Carolina | 28144 | — |
| PMG Research of Winston-Salem, LLC | Winston-Salem | North Carolina | 27103 | — |
| Sterling Research Group, Ltd. | Cincinnati | Ohio | 45219 | — |
| Hillcrest Clinical Research | Oklahoma City | Oklahoma | 73119 | — |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| Low Country Rheumatology, PA | Charleston | South Carolina | 29406 | — |
| PMG Research of Charleston, LLC | Mt. Pleasant | South Carolina | 29464 | — |
| Clinical Research Solutions | Franklin | Tennessee | 37067 | — |
| PMG Research of Knoxville | Knoxville | Tennessee | 37912 | — |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | — |
| Pioneer Research Solutions, Inc. | Cypress | Texas | 77429 | — |
| Southwest Rheumatology Research, LLC | Mesquite | Texas | 75150 | — |
| Center for Arthritis and Rheumatic Diseases | Chesapeake | Virginia | 23320 | — |
| Rheumatology & Pulmonary Clinic | Beckley | West Virginia | 25801 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 81 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03161093, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 14, 2022 · Synced Nov 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03161093 live on ClinicalTrials.gov.