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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02997696
Other study ID # ONO-4474-02
Secondary ID 2016-002675-97
Status Terminated
Phase Phase 2
First received December 2, 2016
Last updated February 23, 2018
Start date January 2017
Est. completion date January 9, 2018

Study information

Verified date February 2018
Source Ono Pharmaceutical Co. Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 administration of ONO-4474.


Recruitment information / eligibility

Status Terminated
Enrollment 70
Est. completion date January 9, 2018
Est. primary completion date January 9, 2018
Accepts healthy volunteers No
Gender All
Age group 40 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
ONO-4474

Placebo matching ONO-4474


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Ono Pharmaceutical Co. Ltd

Countries where clinical trial is conducted

Denmark,  Hungary,  Poland,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Percentage of patients who meet Osteoarthritis Research Society International - Outcome Measures in Rheumatology (OMERACT-OARSI) responder criteria Week 1, Week 2 and Week 4
Other Percentage of patients who report a =30%, =50% or =70% decrease versus baseline in mean daily average index knee pain while walking Weeks 1, 2, 3 and 4, and Weeks 1-4
Other Percentage of patients who report a =30%, =50% or =70% decrease versus baseline in WOMAC pain score Weeks 1, 2 and 4, and Weeks 1-4
Other Percentage of patients who report a =30%, =50% or =70% decrease versus baseline in WOMAC physical function score Weeks 1, 2 and 4, and Weeks 1-4
Other Change from baseline to study completion in mean daily average index knee pain while walking From baseline to study completion, an average of 6 weeks
Other Change from baseline to study completion in WOMAC pain score From baseline to study completion, an average of 6 weeks
Other Change from baseline to study completion in WOMAC physical function score From baseline to study completion, an average of 6 weeks
Other Change from baseline to study completion in PGA From baseline to study completion, an average of 6 weeks
Other Change of daily average index knee pain while walking versus daily physical activity From baseline to study completion, an average of 6 weeks
Other Change of average index knee pain versus daily physical activity From baseline to study completion, an average of 6 weeks
Other Ctrough versus change from baseline to Weeks 1, 2 and 4 in WOMAC pain score Week 1, Week 2 and Week 4
Other Ctrough versus change from baseline to Weeks 1, 2 and 4 in WOMAC physical function score Week 1, Week 2 and Week 4
Other Ctrough versus change from baseline to Weeks 1, 2 and 4 in PGA Week 1, Week 2 and Week 4
Primary Change from baseline in mean daily average index knee pain while walking Week 4
Secondary Safety profile assessed by adverse events, vital signs, laboratory tests, 12-lead electrocardiograms (ECG), physical examination From baseline to study completion, an average of 6 weeks
Secondary Safety of ONO-4474 as assessed by C-SSRS (evaluation of suicidal ideation and behavior) From baseline to study completion, an average of 6 weeks
Secondary Safety of ONO-4474 as assessed by neurological examination From baseline to study completion, an average of 6 weeks
Secondary Change from baseline in mean daily average index knee pain while walking Week 1, Week 2, Week 3 and Weeks 1-4
Secondary Change from baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain, stiffness and physical function scores Week 1, Week 2, Week 4 and Weeks 1-4
Secondary Change from baseline in overall WOMAC score Week 1, Week 2, Week 4 and Weeks 1-4
Secondary Change from baseline in mean daily average index knee pain Week 1, Week 2, Week 3, Week 4 and Weeks 1-4
Secondary Change from baseline in Patient Global Assessment Week 1, Week 2, Week 4 and Weeks 1-4
Secondary Improvement score in Clinical Global Impression Week 1, Week 2, Week 4 and Weeks 1-4
Secondary Change from baseline in: EuroQoL EQ-5D-5L Week 4
Secondary Use of rescue medication as total number of tablets taken Week 1, Week 2, Week 3, Week 4
Secondary Time to first rescue medication use Week 4
Secondary Pharmacokinetics of ONO-4474 in plasma: Ctrough of ONO-4474 Week 1, Week 2 and Week 4
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