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

Primary Purpose

Osteoarthritis, Knee, Pain

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ONO-4474
Placebo matching ONO-4474
Sponsored by
Ono Pharmaceutical Co. Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site
  • Investigational Site
  • Investigational Site 4504
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site 4808
  • Investigational Site 4818
  • Investigational Site 4819
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site 4810
  • Investigational Site 4812
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site 4811
  • Investigational Site 4815
  • Investigational Site
  • Investigational Site 4801
  • Investigational Site 4816
  • Investigational Site
  • Investigational Site 3406
  • Investigational Site 3407
  • Investigational Site 3402
  • Investigational Site 3410
  • Investigational Site
  • Investigational Site
  • Investigator Site
  • Investigational Site
  • Investigational site
  • Investigational Site
  • Investigational Site
  • Investigational Site 4401
  • Investigational Site 4410
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Experimental arm 1

Experimental arm 2

Placebo arm

Arm Description

ONO-4474 low dose every day for 4 weeks

ONO-4474 high dose every day for 4 weeks

Placebo matching ONO-4474 every day for 4 weeks

Outcomes

Primary Outcome Measures

Change from baseline in mean daily average index knee pain while walking

Secondary Outcome Measures

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

Full Information

First Posted
December 2, 2016
Last Updated
February 23, 2018
Sponsor
Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02997696
Brief Title
A Study to Evaluate ONO-4474 in Patients With Pain Due to Osteoarthritis of the Knee
Acronym
MOTION
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped for business reasons. No safety issues were reported.
Study Start Date
January 2017 (Actual)
Primary Completion Date
January 9, 2018 (Actual)
Study Completion Date
January 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 administration of ONO-4474.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental arm 1
Arm Type
Experimental
Arm Description
ONO-4474 low dose every day for 4 weeks
Arm Title
Experimental arm 2
Arm Type
Experimental
Arm Description
ONO-4474 high dose every day for 4 weeks
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Placebo matching ONO-4474 every day for 4 weeks
Intervention Type
Drug
Intervention Name(s)
ONO-4474
Intervention Type
Drug
Intervention Name(s)
Placebo matching ONO-4474
Primary Outcome Measure Information:
Title
Change from baseline in mean daily average index knee pain while walking
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Safety of ONO-4474 as assessed by neurological examination
Time Frame
From baseline to study completion, an average of 6 weeks
Title
Change from baseline in mean daily average index knee pain while walking
Time Frame
Week 1, Week 2, Week 3 and Weeks 1-4
Title
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
Title
Change from baseline in overall WOMAC score
Time Frame
Week 1, Week 2, Week 4 and Weeks 1-4
Title
Change from baseline in mean daily average index knee pain
Time Frame
Week 1, Week 2, Week 3, Week 4 and Weeks 1-4
Title
Change from baseline in Patient Global Assessment
Time Frame
Week 1, Week 2, Week 4 and Weeks 1-4
Title
Improvement score in Clinical Global Impression
Time Frame
Week 1, Week 2, Week 4 and Weeks 1-4
Title
Change from baseline in: EuroQoL EQ-5D-5L
Time Frame
Week 4
Title
Use of rescue medication as total number of tablets taken
Time Frame
Week 1, Week 2, Week 3, Week 4
Title
Time to first rescue medication use
Time Frame
Week 4
Title
Pharmacokinetics of ONO-4474 in plasma: Ctrough of ONO-4474
Time Frame
Week 1, Week 2 and Week 4
Other Pre-specified Outcome Measures:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Change from baseline to study completion in WOMAC pain score
Time Frame
From baseline to study completion, an average of 6 weeks
Title
Change from baseline to study completion in WOMAC physical function score
Time Frame
From baseline to study completion, an average of 6 weeks
Title
Change from baseline to study completion in PGA
Time Frame
From baseline to study completion, an average of 6 weeks
Title
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
Title
Change of average index knee pain versus daily physical activity
Time Frame
From baseline to study completion, an average of 6 weeks
Title
Ctrough versus change from baseline to Weeks 1, 2 and 4 in WOMAC pain score
Time Frame
Week 1, Week 2 and Week 4
Title
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
Title
Ctrough versus change from baseline to Weeks 1, 2 and 4 in PGA
Time Frame
Week 1, Week 2 and Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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, 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Conaghan, MBBS PhD
Organizational Affiliation
Leeds Institute of Rheumatic and Musculoskeletal Medicine, Chapel Allerton Hospital, Leeds, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Investigational Site
City
Aalborg
Country
Denmark
Facility Name
Investigational Site
City
Frederiksberg
Country
Denmark
Facility Name
Investigational Site 4504
City
Odense
Country
Denmark
Facility Name
Investigational Site
City
Balatonfured
Country
Hungary
Facility Name
Investigational Site
City
Budapest
Country
Hungary
Facility Name
Investigational Site
City
Eger
Country
Hungary
Facility Name
Investigational Site
City
Kistarcsa
Country
Hungary
Facility Name
Investigational Site
City
Mezokovesd
Country
Hungary
Facility Name
Investigational Site
City
Szolnok
Country
Hungary
Facility Name
Investigational Site 4808
City
Bialystok
Country
Poland
Facility Name
Investigational Site 4818
City
Bialystok
Country
Poland
Facility Name
Investigational Site 4819
City
Bialystok
Country
Poland
Facility Name
Investigational Site
City
Elblag
Country
Poland
Facility Name
Investigational Site
City
Gdynia
Country
Poland
Facility Name
Investigational Site
City
Katowice
Country
Poland
Facility Name
Investigational Site
City
Kielce
Country
Poland
Facility Name
Investigational Site 4810
City
Krakow
Country
Poland
Facility Name
Investigational Site 4812
City
Krakow
Country
Poland
Facility Name
Investigational Site
City
Lublin
Country
Poland
Facility Name
Investigational Site
City
Nadarzyn
Country
Poland
Facility Name
Investigational Site
City
Poznan
Country
Poland
Facility Name
Investigational Site
City
Siedlce
Country
Poland
Facility Name
Investigational Site
City
Staszow
Country
Poland
Facility Name
Investigational Site 4811
City
Warszawa
Country
Poland
Facility Name
Investigational Site 4815
City
Warszawa
Country
Poland
Facility Name
Investigational Site
City
Wroclaw
Country
Poland
Facility Name
Investigational Site 4801
City
Zamosc
Country
Poland
Facility Name
Investigational Site 4816
City
Zamosc
Country
Poland
Facility Name
Investigational Site
City
A Coruna
Country
Spain
Facility Name
Investigational Site 3406
City
Barcelona
Country
Spain
Facility Name
Investigational Site 3407
City
Barcelona
Country
Spain
Facility Name
Investigational Site 3402
City
Madrid
Country
Spain
Facility Name
Investigational Site 3410
City
Madrid
Country
Spain
Facility Name
Investigational Site
City
Mostoles
Country
Spain
Facility Name
Investigational Site
City
Sabadell
Country
Spain
Facility Name
Investigator Site
City
Santiago de Compostela
Country
Spain
Facility Name
Investigational Site
City
Sevilla
Country
Spain
Facility Name
Investigational site
City
Villajoyosa
Country
Spain
Facility Name
Investigational Site
City
Barnsley
Country
United Kingdom
Facility Name
Investigational Site
City
Blackpool
Country
United Kingdom
Facility Name
Investigational Site 4401
City
Leeds
Country
United Kingdom
Facility Name
Investigational Site 4410
City
Leeds
Country
United Kingdom
Facility Name
Investigational Site
City
Liverpool
Country
United Kingdom
Facility Name
Investigational Site
City
Manchester
Country
United Kingdom
Facility Name
Investigational Site
City
Middlesex
Country
United Kingdom
Facility Name
Investigational Site
City
North Shields
Country
United Kingdom
Facility Name
Investigational Site
City
Romford
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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