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

ID: NCT02997696
Status: Terminated
Phase: Phase 2
Start Date: January 01, 2017
First Submitted: December 02, 2016
Last Updated: February 23, 2018
Results: N/A
Sponsors & Collaborators: Ono Pharmaceutical Co. Ltd
Location: Denmark, Hungary, Poland, Spain, United Kingdom
Conditions: Osteoarthritis, Knee, Pain
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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.

Detailed Description

Condition or disease Intervention/treatment Phase

Osteoarthritis, Knee

Pain

Drug: ONO-4474
Other Names
Drug: Placebo matching ONO-4474
Other Names
Phase 2

Tracking Information

First Submitted DateDecember 02, 2016
Last Update Posted DateFebruary 23, 2018
Actual Start DateJanuary 01, 2017
Actual Completion DateJanuary 09, 2018
Actual Primary Completion DateJanuary 09, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

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

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • 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]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleA Study to Evaluate ONO-4474 in Patients With Pain Due to Osteoarthritis of the Knee
Official TitleA 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
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.

Detailed Description

Study TypeInterventional
Study PhasePhase 2
Estimated Enrollment
70
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Quadruple
Primary Purpose
Treatment
Conditions
Osteoarthritis, Knee
Pain
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: ONO-4474

Other Names
Drug: Placebo matching ONO-4474

Other Names
Study Groups/Cohorts
Experimental arm 1
ONO-4474 low dose every day for 4 weeks

Experimental arm 2
ONO-4474 high dose every day for 4 weeks

Placebo arm
Placebo matching ONO-4474 every day for 4 weeks

Study Arms
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

Arm Intervention/Treatment
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

Recruitment Information

Recruitment Status:Terminated
Enrollment70
Completion DateJanuary 09, 2018
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,
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.
GenderAll
Age40 Years to 75 Years
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Denmark
Hungary
Poland
Spain
United Kingdom

Administrative Information

NCT Number:NCT02997696
Other Study ID Numbers
ONO-4474-02
2016-002675-97
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Ono Pharmaceutical Co. Ltd
Collaborators
Not Available
Investigators
Principal Investigator
Philip Conaghan, MBBS PhD
Leeds Institute of Rheumatic and Musculoskeletal Medicine, Chapel Allerton Hospital, Leeds, UK