Osteoarthritis, KneePhase 2MOTIONNCT02997696
A Study to Evaluate ONO-4474 in Patients With Pain Due to Osteoarthritis of the Knee
A Phase 2 study testing ONO-4474 in people with Osteoarthritis, Knee and Pain, run by Ono Pharmaceutical Co., Ltd. at 47 sites in 5 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee, Pain
- What is being tested?
- ONO-4474
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 47 sitesin 5 countries
- Study dates
- Jan 2017to 9 Jan 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Presence of, or history of,
- 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),
- RPOA, osteonecrosis, osteoporotic fracture or any other painful joint disease other than OA,
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
47 sites in 5 countries.
47 sites in 5 countries
Poland19 sites
Investigational Site 4808
Bialystok
Investigational Site 4818
Bialystok
Investigational Site 4819
Bialystok
Investigational Site
Elblag
Investigational Site
Gdynia
Investigational Site
Katowice
Investigational Site
Kielce
Investigational Site 4810
Krakow
Investigational Site 4812
Krakow
Investigational Site
Lublin
Investigational Site
Nadarzyn
Investigational Site
Poznan
Investigational Site
Siedlce
Investigational Site
Staszów
Investigational Site 4811
Warsaw
Investigational Site 4815
Warsaw
Investigational Site
Wroclaw
Investigational Site 4801
Zamość
Investigational Site 4816
Zamość
Spain10 sites
Investigational Site
A Coruña
Investigational Site 3406
Barcelona
Investigational Site 3407
Barcelona
Investigational Site 3402
Madrid
Investigational Site 3410
Madrid
Investigational Site
Móstoles
Investigational Site
Sabadell
Investigator Site
Santiago de Compostela
Investigational Site
Seville
Investigational site
Villajoyosa
United Kingdom9 sites
Investigational Site
Barnsley
Investigational Site
Blackpool
Investigational Site 4401
Leeds
Investigational Site 4410
Leeds
Investigational Site
Liverpool
Investigational Site
Manchester
Investigational Site
Middlesex
Investigational Site
North Shields
Investigational Site
Romford
Hungary6 sites
Investigational Site
Balatonfüred
Investigational Site
Budapest
Investigational Site
Eger
Investigational Site
Kistarcsa
Investigational Site
Mezőkövesd
Investigational Site
Szolnok
Denmark3 sites
Investigational Site
Aalborg
Investigational Site
Frederiksberg
Investigational Site 4504
Odense
About this study
Official title: 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.
- Conditions
- Osteoarthritis, Knee, Pain
- Being tested
- ONO-4474, Placebo matching ONO-4474
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-4474Drug
Placebo matching ONO-4474Drug
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm 1 | Experimental | ONO-4474 low dose every day for 4 weeks Receives: Drug: ONO-4474 |
| Experimental arm 2 | Experimental | ONO-4474 high dose every day for 4 weeks Receives: Drug: ONO-4474 |
| Placebo arm | Placebo comparator | Placebo matching ONO-4474 every day for 4 weeks Receives: Drug: Placebo matching ONO-4474 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean daily average index knee pain while walking
Measured: Week 4
Secondary outcomes (13)
Safety profile assessed by adverse events, vital signs, laboratory tests, 12-lead electrocardiograms (ECG), physical examination
Measured: 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)
Measured: From baseline to study completion, an average of 6 weeks
Safety of ONO-4474 as assessed by neurological examination
Measured: From baseline to study completion, an average of 6 weeks
Change from baseline in mean daily average index knee pain while walking
Measured: 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
Measured: Week 1, Week 2, Week 4 and Weeks 1-4
Change from baseline in overall WOMAC score
Measured: Week 1, Week 2, Week 4 and Weeks 1-4
Change from baseline in mean daily average index knee pain
Measured: Week 1, Week 2, Week 3, Week 4 and Weeks 1-4
Change from baseline in Patient Global Assessment
Measured: Week 1, Week 2, Week 4 and Weeks 1-4
Improvement score in Clinical Global Impression
Measured: Week 1, Week 2, Week 4 and Weeks 1-4
Change from baseline in: EuroQoL EQ-5D-5L
Measured: Week 4
Use of rescue medication as total number of tablets taken
Measured: Week 1, Week 2, Week 3, Week 4
Time to first rescue medication use
Measured: Week 4
Pharmacokinetics of ONO-4474 in plasma: Ctrough of ONO-4474
Measured: Week 1, Week 2 and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startJan 2017
- Primary completion9 Jan 2018
- Study completion9 Jan 2018
Why it stopped: The study was stopped for business reasons. No safety issues were reported.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Conaghan, MBBS PhD, Principal investigator, Leeds Institute of Rheumatic and Musculoskeletal Medicine, Chapel Allerton Hospital, Leeds, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997696
- Sponsor's protocol ID
- ONO-4474-02
- Other IDs
- 2016-002675-97, 2016
- Acronym
- MOTION
- Status last verified
- Feb 2018
- First submitted
- 2 Dec 2016
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02997696
- Acronym / sponsor ID
- MOTION / ONO-4474-02
- Conditions
- Osteoarthritis, Knee, Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped for business reasons. No safety issues were reported.
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2017 (actual)
- Primary completion
- 9 Jan 2018 (actual)
- Study completion
- 9 Jan 2018 (actual)
- First posted
- 20 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental arm 1 | Experimental | Drug: ONO-4474ONO-4474 low dose every day for 4 weeks |
| Experimental arm 2 | Experimental | Drug: ONO-4474ONO-4474 high dose every day for 4 weeks |
| Placebo arm | Placebo comparator | Drug: Placebo matching ONO-4474Placebo matching ONO-4474 every day for 4 weeks |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- Presence of, or history of,
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-4474 | Drug | Experimental arm 1, Experimental arm 2 |
| Placebo matching ONO-4474 | Drug | Placebo arm |
Primary outcome
Change from baseline in mean daily average index knee pain while walking
Time frame: Week 4
13 secondary outcomes
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
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
Safety of ONO-4474 as assessed by neurological examination
Time frame: 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
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
Change from baseline in overall WOMAC score
Time frame: 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
Change from baseline in Patient Global Assessment
Time frame: 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
Change from baseline in: EuroQoL EQ-5D-5L
Time frame: Week 4
Use of rescue medication as total number of tablets taken
Time frame: Week 1, Week 2, Week 3, Week 4
Time to first rescue medication use
Time frame: Week 4
Pharmacokinetics of ONO-4474 in plasma: Ctrough of ONO-4474
Time frame: Week 1, Week 2 and Week 4
Results and safety
The study was stopped early (reason given: The study was stopped for business reasons. No safety issues were reported.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Conaghan, MBBS PhD principal investigator
Leeds Institute of Rheumatic and Musculoskeletal Medicine, Chapel Allerton Hospital, Leeds, UK
47 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ONO-4474 in people with Osteoarthritis, Knee and Pain, run by Ono Pharmaceutical Co., Ltd. at 47 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Poland, Spain, United Kingdom, Hungary, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was stopped for business reasons. No safety issues were reported.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in mean daily average index knee pain while walking (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018.