Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip (FACT OA2)

January 30, 2023 updated by: Regeneron Pharmaceuticals

Phase 3 Randomized, Double-Blind, Multi-Dose, Placebo And NSAID Controlled Study To Evaluate The Efficacy And Safety Of Fasinumab In Patients With Pain Due To Osteoarthritis Of The Knee Or Hip

The primary objective of the study is to evaluate the efficacy of fasinumab compared to placebo, when administered for up to 24 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip.

The secondary objectives of the study are:

  • To evaluate the efficacy of fasinumab compared to non-steroidal anti-inflammatory drugs (NSAID)s, when administered for up to 24 weeks in patients with pain due to OA of the knee or hip
  • To assess the safety and tolerability of fasinumab compared to placebo and compared to NSAIDs, when administered for up to 24 weeks in patients with pain due to OA of the knee or hip

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1650

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group, LLC
      • Mobile, Alabama, United States, 36608
        • Horizon Research Partners
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Clinical Research Advantage, Inc./Warner Family Practice, PC
      • Phoenix, Arizona, United States, 85020
        • Synexus Central Phoenix Medical Clinic
      • Tempe, Arizona, United States, 85283
        • Clinical Research Consortium Arizona
    • California
      • Anaheim, California, United States, 92805
        • Advance Research Center
      • El Cajon, California, United States, 92020
        • TriWest Research Associates, LLC
      • Garden Grove, California, United States, 92840
        • Paragon Rx Clinical Research, Inc.
      • Montclair, California, United States, 91763
        • Catalina Research Institute, LLC
      • Roseville, California, United States, 95661
        • Sierra Clinical Research
      • Sacramento, California, United States, 95817
        • UC Davis Center for Musculoskeletal Health
      • San Diego, California, United States, 92123
        • California Research Foundation
      • San Diego, California, United States, 92103
        • Advanced Research Center, Inc
      • Santa Ana, California, United States, 92703
        • Paragon Rx Clinical Research, Inc
      • Spring Valley, California, United States, 91978
        • Encompass Clinical Research
      • Thousand Oaks, California, United States, 91360
        • Westlake Medical Research
      • Vista, California, United States, 92083
        • Synexus Clinical Research US, Inc.
    • Colorado
      • Denver, Colorado, United States, 80209
        • Mountain View Clinical Research
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • New England Research Associates, LLC
      • Hamden, Connecticut, United States, 06157
        • CRM of Greater New Haven, LLC
      • Stamford, Connecticut, United States, 06905
        • Stamford Therapeutics Consortium
    • Florida
      • DeLand, Florida, United States, 32720
        • Avail Clinical Research, LLC
      • Miami, Florida, United States, 33144
        • AMB Research Center, Inc
      • Miami, Florida, United States, 33155
        • Allied Biomedical Research Institute
      • Miami Lakes, Florida, United States, 33014
        • Lakes Research, LLC
      • Orlando, Florida, United States, 32806
        • Bioclinica Research
      • Pensacola, Florida, United States, 32514
        • Gulf Region Clinical Research Institute
      • Plantation, Florida, United States, 33324
        • Integral Rheumatology & Immunology Specialists (IRIS)
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Drug Studies America
      • Marietta, Georgia, United States, 30060
        • Georgia Institute For Clinical Research Llc
      • Woodstock, Georgia, United States, 30189
        • North Georgia Clinical Research
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Chicago Clinical Research Institute, Inc
      • Oak Lawn, Illinois, United States, 60453
        • Affinity Clinical Research Institute
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Medisphere Medical Research Center, Llc
      • Evansville, Indiana, United States, 47714
        • Clinical Research Advantage, Inc.
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • L-MARC Research Center
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Tandem Clinical Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center, Inc.
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Great Lakes Research Group, Inc.
      • Caro, Michigan, United States, 48723
        • Onyx Clinical Research
    • Minnesota
      • Richfield, Minnesota, United States, 55423
        • Synexus Clinical Research US, Inc.
    • Nebraska
      • Elkhorn, Nebraska, United States, 68022
        • Skyline Medical Center /Radiant Research, Inc.
      • Omaha, Nebraska, United States, 68134
        • Meridian Clinical Research Associates, LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Robert Kaplan, D.O.
    • New Jersey
      • Raritan, New Jersey, United States, 08869
        • Amici Clinical Research, LLC
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clinical Trials, Inc.
    • New York
      • Brooklyn, New York, United States, 11230
        • Drug Trial Brooklyn
      • Great Neck, New York, United States, 11021
        • Northwell Health
      • Hartsdale, New York, United States, 10530
        • Drug Trials America
      • Williamsville, New York, United States, 14221
        • Upstate Clinical Research Associates, LLC
    • North Carolina
      • Shelby, North Carolina, United States, 28150
        • Carolina Research Center
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington LLC
      • Winston-Salem, North Carolina, United States, 27103
        • The Center for Clinical Research
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • New Horizons Clinical Research
      • Columbus, Ohio, United States, 43213
        • Aventiv Research Inc
      • Dayton, Ohio, United States, 45432
        • DOC Clinical Research
    • Pennsylvania
      • Indiana, Pennsylvania, United States, 15701
        • Center for Orthopaedics and Sports Medicine
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Radiant Research, Inc.
      • Greenville, South Carolina, United States, 29601
        • Piedmont Comprehensive Pain Management Group
      • Greer, South Carolina, United States, 29651
        • Radiant Research, Inc.
      • Indian Land, South Carolina, United States, 29707
        • Piedmont Research Partners, LLC
      • North Charleston, South Carolina, United States, 29406
        • Coastal Carolina Research Center at LowCountry Orthopaedics
      • Orangeburg, South Carolina, United States, 29118
        • Acme Research, Llc
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Office of Dr.Ramesh C. Gupta MD
    • Texas
      • Lubbock, Texas, United States, 79410
        • West Texas Clinical Research
      • Plano, Texas, United States, 75075
        • Clinical Investigations of Texas
      • Plano, Texas, United States, 75093
        • Synexus USA
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Charlottesville Medical Research Center LLC
      • Newport News, Virginia, United States, 23606
        • Health Research of Hampton Roads, Inc
    • Washington
      • Spokane, Washington, United States, 99218
        • Spokane Joint Replacement Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria (additional criteria may apply at screening):

  1. A clinical diagnosis of osteoarthritis (OA) of the knee or hip based on the American College of Rheumatology criteria with radiologic evidence of OA (K-L score ≥2 for the index joint) at the screening visit.
  2. Willing to discontinue current pain medications and to adhere to study requirements for rescue treatments (acetaminophen/paracetamol to be taken as needed with a maximum daily dose of 2500 mg [countries where 500 mg strength tablets/capsules are available] or 2600 mg [countries where 325 mg strength tablets/capsules are available])
  3. A history of at least 12 weeks of inadequate pain relief or intolerance to analgesics used for pain due to OA of the knee or hip
  4. Currently using a stable dose of NSAID
  5. Willing to discontinue glucosamine sulfate and chondroitin sulfate treatments during the 24 weeks of treatment

Key Exclusion Criteria (additional criteria may apply at screening):

  1. Non-compliance with the numeric rating scale (NRS) recording during the pre-randomization period
  2. History or presence at the screening visit of non-OA inflammatory joint disease, Paget's disease of the spine, pelvis or femur, neuropathic disorders, multiple sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal osteodystrophy
  3. History or presence on imaging of arthropathy, hip or knee dislocation, extensive subchondral cysts, evidence of severe structural damage, bone collapse, or primary metastatic tumor with the exception of chondromas or pathologic fractures
  4. Trauma to the index joint within 3 months prior to the screening visit
  5. Signs or symptoms of carpal tunnel syndrome within 6 months of screening
  6. Patient is not a candidate for magnetic resonance imaging (MRI)
  7. Is scheduled for a JR surgery to be performed during the study period or who would be unwilling or unable to undergo JR surgery if needed
  8. History or presence at the screening visit of autonomic or diabetic neuropathy, or other peripheral neuropathy, including reflex sympathetic dystrophy
  9. Evidence of autonomic neuropathy as defined in the schedule of assessments (SoAs)
  10. History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy
  11. Use of systemic corticosteroids within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks prior to the screening visit, or to any other joint within 30 days prior to the screening visit
  12. Exposure to an anti-NGF antibody prior to the screening visit or known sensitivity or intolerance to anti-NGF antibodies
  13. Women of childbearing potential who are unwilling to practice highly effective contraception prior to the start of the first treatment, during the study, and for at least 20 weeks after the last dose

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dosing regimen 1
Drug: Fasinumab
Solution for injection in pre-filled syringe
Other Names:
  • REGN475
  • MT-5547
Drug: Matching placebo
Fasinumab-matching placebo (solution for injection in pre-filled syringe); NSAID-matching placebo (capsule)
Experimental: Dosing regimen 2
Drug: Matching placebo
Fasinumab-matching placebo (solution for injection in pre-filled syringe); NSAID-matching placebo (capsule)
Other: Diclofenac
NSAID active comparator (capsule)
Other Names:
  • ZORVOLEX
Experimental: Dosing regimen 3
Drug: Matching placebo
Fasinumab-matching placebo (solution for injection in pre-filled syringe); NSAID-matching placebo (capsule)
Other: Celecoxib
NSAID active comparator (capsule)
Other Names:
  • CELEBREX
Experimental: Dosing regimen 4
Drug: Matching placebo
Fasinumab-matching placebo (solution for injection in pre-filled syringe); NSAID-matching placebo (capsule)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo
Time Frame: Baseline up to Week 24
WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in past 48 hours. It was calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (higher pain), where higher scores indicated higher pain.
Baseline up to Week 24
Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo
Time Frame: Baseline up to Week 24
Physical function referred to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty.
Baseline up to Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Greater Than or Equal to (≥) 30 Percent (%) Reduction From Baseline up to Week 24 in WOMAC Pain Subscale Score in Participants Treated With Fasinumab Compared to Placebo
Time Frame: Baseline up to Week 24
WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.
Baseline up to Week 24
Change From Baseline in Patient Global Assessment (PGA) Score up to Week 24 in Participants Treated With Fasinumab Compared to Placebo
Time Frame: Baseline up to Week 24
The PGA was a patient-rated assessment of current disease state on a 5-point Likert scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which were intolerable and inability to carry out all normal activities). Higher score indicated severe condition.
Baseline up to Week 24
Change From Baseline in WOMAC Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs
Time Frame: Baseline up to Week 24
WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a NRS of 0 (no pain) to 10 (higher pain), where higher scores indicated higher pain.
Baseline up to Week 24
Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs
Time Frame: Baseline up to Week 24
Physical function referred to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty.
Baseline up to Week 24
Change From Baseline in PGA Score up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs
Time Frame: Baseline up to Week 24
The PGA was a patient-rated assessment of current disease state on a 5-point Likert scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which were intolerable and inability to carry out all normal activities). Higher score indicated severe condition.
Baseline up to Week 24
Change From Baseline in Weekly Average Walking Index Joint Pain Score up to Week 24 by Using the Numeric Rating Scale (NRS) Pain Scale
Time Frame: Baseline up to Week 24
Participants reported weekly average walking index joint pain based on NRS. The NRS was nationally recognized numeric scale from 0 to 10, where 0 would demonstrate no pain, 1 to 3 would demonstrate mild pain, 4 to 6 would be moderate pain, 7 to 9 would be severe pain and 10 would be the worst pain possible. Higher score indicated greater pain.
Baseline up to Week 24
Number of Participants With Adjudicated Arthropathy (AA) Events
Time Frame: Baseline up to follow-up period (Week 44)
AA was a composite term that encompasses the following conditions: Rapidly progressive Osteoarthritis (OA) type 1 and 2, Subchondral insufficiency fractures, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee. AAs were also evaluated to determine if they met Destructive Arthropathy criteria.
Baseline up to follow-up period (Week 44)
Number of Participants With AA Events Meeting Destructive Arthropathy (DA) Criteria
Time Frame: Baseline up to follow-up period (Week 44)
DA is a unique clinical form of rapidly destructive arthropathy over and above that seen in the normal progression of OA. DA criteria can be associated with Rapidly Progressive OA type 2, Subchondral Insufficiency fracture, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee.
Baseline up to follow-up period (Week 44)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: Baseline up to follow-up period (Week 44)
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. TEAE was defined as an AE with an onset that occurs after receiving study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious TEAEs.
Baseline up to follow-up period (Week 44)
Number of Participants With Sympathetic Nervous System (SNS) Dysfunction Events
Time Frame: Baseline up to follow-up period (Week 44)
Potential events of SNS dysfunction were monitored throughout the study through physical examination, AE reporting, assessment of orthostatic hypotension, and the Survey of Autonomic Symptoms. Sympathetic nervous system dysfunction was diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist.
Baseline up to follow-up period (Week 44)
Number of Participants With At-least One Peripheral Sensory Adverse Events (AEs)
Time Frame: Baseline up to Week 44
Any participants with a peripheral sensory event that persisted for 2 months was referred for a neurology or other specialty consultation and reported as an Adverse Events of Special Interest (AESI).
Baseline up to Week 44
Number of Participants Who Underwent a Joint Replacements (JR) Surgery From Baseline up to Week 24
Time Frame: Baseline up to Week 24
Number of participants who underwent a JR surgery from baseline up to Week 24 were reported.
Baseline up to Week 24
Number of Participants Who Underwent a Joint Replacements (JR) Surgery From Baseline up to Week 44
Time Frame: Baseline up to Week 44
Number of participants who underwent a JR surgery from baseline up to follow-up period (Week 44) were reported.
Baseline up to Week 44
Number of Participants With Joint Replacement (JR) Surgery Reported at End of Study (EOS) (Week 72)
Time Frame: At Week 72
An EOS phone contact was conducted at Week 72 following the last dose of study drug (Week 24) to evaluate the number of participants who had undergone or were scheduled for JR surgery.
At Week 72
Serum Concentrations of Functional Fasinumab
Time Frame: At Weeks 0, 4, 8, 16, 24 and 44
At Weeks 0, 4, 8, 16, 24 and 44
Number of Participants With At-least One Positive Anti-Drug Antibody (ADA) Development
Time Frame: Baseline up to Week 44
Immunogenicity was characterized by ADA responses & titers. Responses categories: Pre-existing immunoreactivity - ADA positive response at baseline with all post first dose negative results or positive response at baseline with all post first dose ADA responses < 9-fold over baseline titer levels; Treatment-boosted response - positive response in the assay post first dose, >= 9-fold over baseline titer levels, when baseline results are positive; Treatment-emergent response - ADA positive response post first dose when baseline results = negative or missing.
Baseline up to Week 44

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regeneron Pharmaceuticals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Teva Pharmaceutical Industries, Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 13, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 9, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R475-OA-1688
  • 2017-001702-15 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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