A Study to Evaluate ONO-4474 in Patients With Pain Due to Osteoarthritis of the Knee (MOTION)

February 23, 2018 updated by: Ono Pharmaceutical Co. Ltd

A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of ONO-4474 in Patients With Pain Due to Osteoarthritis of the Knee

The purpose of this phase 2, randomised, double-blind, placebo controlled, parallel group, multicentre study is to investigate the efficacy, safety, tolerability and pharmacokinetics of a compound ONO-4474 in patients with moderate to severe pain due to osteoarthritis of the knee following 4 weeks of oral administration of ONO-4474.

Study Overview

Status

Status

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

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.
70

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 2

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

  • Denmark
      • Aalborg, Denmark
        • Investigational Site
      • Frederiksberg, Denmark
        • Investigational Site
      • Odense, Denmark
        • Investigational Site 4504
  • Hungary
      • Balatonfured, Hungary
        • Investigational Site
      • Budapest, Hungary
        • Investigational Site
      • Eger, Hungary
        • Investigational Site
      • Kistarcsa, Hungary
        • Investigational Site
      • Mezokovesd, Hungary
        • Investigational Site
      • Szolnok, Hungary
        • Investigational Site
  • Poland
      • Bialystok, Poland
        • Investigational Site 4808
      • Bialystok, Poland
        • Investigational Site 4818
      • Bialystok, Poland
        • Investigational Site 4819
      • Elblag, Poland
        • Investigational Site
      • Gdynia, Poland
        • Investigational Site
      • Katowice, Poland
        • Investigational Site
      • Kielce, Poland
        • Investigational Site
      • Krakow, Poland
        • Investigational Site 4810
      • Krakow, Poland
        • Investigational Site 4812
      • Lublin, Poland
        • Investigational Site
      • Nadarzyn, Poland
        • Investigational Site
      • Poznan, Poland
        • Investigational Site
      • Siedlce, Poland
        • Investigational Site
      • Staszow, Poland
        • Investigational Site
      • Warszawa, Poland
        • Investigational Site 4811
      • Warszawa, Poland
        • Investigational Site 4815
      • Wroclaw, Poland
        • Investigational Site
      • Zamosc, Poland
        • Investigational Site 4801
      • Zamosc, Poland
        • Investigational Site 4816
  • Spain
      • A Coruna, Spain
        • Investigational Site
      • Barcelona, Spain
        • Investigational Site 3406
      • Barcelona, Spain
        • Investigational Site 3407
      • Madrid, Spain
        • Investigational Site 3402
      • Madrid, Spain
        • Investigational Site 3410
      • Mostoles, Spain
        • Investigational Site
      • Sabadell, Spain
        • Investigational Site
      • Santiago de Compostela, Spain
        • Investigator Site
      • Sevilla, Spain
        • Investigational Site
      • Villajoyosa, Spain
        • Investigational Site
  • United Kingdom
      • Barnsley, United Kingdom
        • Investigational Site
      • Blackpool, United Kingdom
        • Investigational Site
      • Leeds, United Kingdom
        • Investigational Site 4401
      • Leeds, United Kingdom
        • Investigational Site 4410
      • Liverpool, United Kingdom
        • Investigational Site
      • Manchester, United Kingdom
        • Investigational Site
      • Middlesex, United Kingdom
        • Investigational Site
      • North Shields, United Kingdom
        • Investigational Site
      • Romford, United Kingdom
        • Investigational Site

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

36 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Symptomatic OA of the knee for ≥3 months diagnosed prior to screening as per American College of Rheumatology clinical criteria.
  • Radiographic evidence of tibiofemoral OA of index knee (Kellgren-Lawrence grade 2-3), as confirmed at screening.
  • Moderate to severe index knee pain due to OA requiring use of analgesic medication.
  • Willing to discontinue use of all analgesic medication (aside from rescue medication) during the study.

Exclusion Criteria:

  • Presence of, or history of,

    1. any inflammatory arthritis (e.g. gout, reactive arthritis, psoriatic arthritis, seronegative spondylarthropathy, septic arthritis, previous diagnosis of pseudogout in target joint with proven crystals on joint aspiration or elevated C-Reactive Protein (CRP) at time of knee arthritis flare),
    2. RPOA, osteonecrosis, osteoporotic fracture or any other painful joint disease other than OA,
    3. Secondary causes of OA; other rheumatologic or musculoskeletal conditions (e.g., rheumatoid arthritis, fibromyalgia, septic arthritis, congenital abnormality).
  • Orthopaedic surgery of a lower extremity or any major surgery within the previous 6 months prior to Visit 1 or has plans for surgical intervention during the study.
  • Symptomatic hip OA.
  • A history of partial or complete joint replacement surgery in the index knee at any time or anticipating knee surgery during the study period.
  • Significant knee injury or any knee surgery (including arthroscopy) in the index knee within 6 months prior to screening.
  • Uncontrolled diabetes.

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: Quadruple

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: Experimental arm 1
ONO-4474 low dose every day for 4 weeks
Drug: ONO-4474
Experimental: Experimental arm 2
ONO-4474 high dose every day for 4 weeks
Drug: ONO-4474
Placebo Comparator: Placebo arm
Placebo matching ONO-4474 every day for 4 weeks
Drug: Placebo matching ONO-4474

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
Time Frame
Change from baseline in mean daily average index knee pain while walking
Time Frame: Week 4
Week 4

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
Time Frame
Safety profile assessed by adverse events, vital signs, laboratory tests, 12-lead electrocardiograms (ECG), physical examination
Time Frame: From baseline to study completion, an average of 6 weeks
From baseline to study completion, an average of 6 weeks
Safety of ONO-4474 as assessed by C-SSRS (evaluation of suicidal ideation and behavior)
Time Frame: From baseline to study completion, an average of 6 weeks
From baseline to study completion, an average of 6 weeks
Safety of ONO-4474 as assessed by neurological examination
Time Frame: From baseline to study completion, an average of 6 weeks
From baseline to study completion, an average of 6 weeks
Change from baseline in mean daily average index knee pain while walking
Time Frame: Week 1, Week 2, Week 3 and Weeks 1-4
Week 1, Week 2, Week 3 and Weeks 1-4
Change from baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain, stiffness and physical function scores
Time Frame: Week 1, Week 2, Week 4 and Weeks 1-4
Week 1, Week 2, Week 4 and Weeks 1-4
Change from baseline in overall WOMAC score
Time Frame: Week 1, Week 2, Week 4 and Weeks 1-4
Week 1, Week 2, Week 4 and Weeks 1-4
Change from baseline in mean daily average index knee pain
Time Frame: Week 1, Week 2, Week 3, Week 4 and Weeks 1-4
Week 1, Week 2, Week 3, Week 4 and Weeks 1-4
Change from baseline in Patient Global Assessment
Time Frame: Week 1, Week 2, Week 4 and Weeks 1-4
Week 1, Week 2, Week 4 and Weeks 1-4
Improvement score in Clinical Global Impression
Time Frame: Week 1, Week 2, Week 4 and Weeks 1-4
Week 1, Week 2, Week 4 and Weeks 1-4
Change from baseline in: EuroQoL EQ-5D-5L
Time Frame: Week 4
Week 4
Use of rescue medication as total number of tablets taken
Time Frame: Week 1, Week 2, Week 3, Week 4
Week 1, Week 2, Week 3, Week 4
Time to first rescue medication use
Time Frame: Week 4
Week 4
Pharmacokinetics of ONO-4474 in plasma: Ctrough of ONO-4474
Time Frame: Week 1, Week 2 and Week 4
Week 1, Week 2 and Week 4

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Percentage of patients who meet Osteoarthritis Research Society International - Outcome Measures in Rheumatology (OMERACT-OARSI) responder criteria
Time Frame: Week 1, Week 2 and Week 4
Week 1, Week 2 and Week 4
Percentage of patients who report a ≥30%, ≥50% or ≥70% decrease versus baseline in mean daily average index knee pain while walking
Time Frame: Weeks 1, 2, 3 and 4, and Weeks 1-4
Weeks 1, 2, 3 and 4, and Weeks 1-4
Percentage of patients who report a ≥30%, ≥50% or ≥70% decrease versus baseline in WOMAC pain score
Time Frame: Weeks 1, 2 and 4, and Weeks 1-4
Weeks 1, 2 and 4, and Weeks 1-4
Percentage of patients who report a ≥30%, ≥50% or ≥70% decrease versus baseline in WOMAC physical function score
Time Frame: Weeks 1, 2 and 4, and Weeks 1-4
Weeks 1, 2 and 4, and Weeks 1-4
Change from baseline to study completion in mean daily average index knee pain while walking
Time Frame: From baseline to study completion, an average of 6 weeks
From baseline to study completion, an average of 6 weeks
Change from baseline to study completion in WOMAC pain score
Time Frame: From baseline to study completion, an average of 6 weeks
From baseline to study completion, an average of 6 weeks
Change from baseline to study completion in WOMAC physical function score
Time Frame: From baseline to study completion, an average of 6 weeks
From baseline to study completion, an average of 6 weeks
Change from baseline to study completion in PGA
Time Frame: From baseline to study completion, an average of 6 weeks
From baseline to study completion, an average of 6 weeks
Change of daily average index knee pain while walking versus daily physical activity
Time Frame: From baseline to study completion, an average of 6 weeks
From baseline to study completion, an average of 6 weeks
Change of average index knee pain versus daily physical activity
Time Frame: From baseline to study completion, an average of 6 weeks
From baseline to study completion, an average of 6 weeks
Ctrough versus change from baseline to Weeks 1, 2 and 4 in WOMAC pain score
Time Frame: Week 1, Week 2 and Week 4
Week 1, Week 2 and Week 4
Ctrough versus change from baseline to Weeks 1, 2 and 4 in WOMAC physical function score
Time Frame: Week 1, Week 2 and Week 4
Week 1, Week 2 and Week 4
Ctrough versus change from baseline to Weeks 1, 2 and 4 in PGA
Time Frame: Week 1, Week 2 and Week 4
Week 1, Week 2 and Week 4

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.
Ono Pharmaceutical Co. Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Philip Conaghan, MBBS PhD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, Chapel Allerton Hospital, Leeds, UK

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.
January 1, 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.
January 9, 2018

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.
January 9, 2018

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).
December 2, 2016

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.
December 15, 2016

First Posted (Estimate)

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.
December 20, 2016

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 26, 2018

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.
February 23, 2018

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.
February 1, 2018

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.
  • ONO-4474-02
  • 2016-002675-97 (EudraCT Number)

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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