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A Study to Evaluate ONO-4474 ...

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

Last Updated: 2018-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-01-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis, Knee Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental arm 1

ONO-4474 low dose every day for 4 weeks

Group Type EXPERIMENTAL

ONO-4474

Intervention Type DRUG

Experimental arm 2

ONO-4474 high dose every day for 4 weeks

Group Type EXPERIMENTAL

ONO-4474

Intervention Type DRUG

Placebo arm

Placebo matching ONO-4474 every day for 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo matching ONO-4474

Intervention Type DRUG

Interventions

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ONO-4474

Intervention Type DRUG

Placebo matching ONO-4474

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers