Efficacy and Safety of 3 Doses of S201086/GLPG1972 Administered Orally Once Daily in Patients with Knee Osteoarthritis. A 52-Week International, Multi-Regional, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study.

  • STATUS
    Recruiting
Updated on 23 November 2020

Summary

An investigational product administered orally for patients with osteoarthritis of the knee.

 

Description

  • Three dose ranges of investigational product versus Placebo.
  • Patients can remain on their NSAID throughout the trial.
  • Details
    Condition Osteoarthritis
    Clinical Study IdentifierTX217835
    Last Modified on23 November 2020

    Eligibility

    Yes No Not Sure

    Inclusion Criteria

    Is your age between 40 yrs and 75 yrs?
    Gender: Male or Female
    Do you have Osteoarthritis?
    Male/Female patients of non-childbearing potential. (women must be surgically sterile or postmenopausal)
    Age 40-75 (inclusive)
    BMI less than 40
    OA Dx – which includes: knee pain, presence of osteophytes, and at least 1 of the following: Age >50, Morning Stiffness <30 Min. Duration, OR Crepitus on active motion
    Kellgren Lawrence grade 2 or 3 knees
    Must have 4 MRIs during trial

    Exclusion Criteria

    Excludes fibromyalgia, inflammatory/rheumatic joint diseases
    Excludes history of malignancy in the past 5 years except basal/squamous cell, cervical/prostate in situ treatment less than two years
    Excludes chronic use of strong opioids
    No bisphosphonates or denozumab in previous 12 months
    Excludes history of other severe or unstable diseases which may be assessed by the Principal/Sub Investigator
    No Arthroscopy of the target knee less than six mo. of screening
    No corticosteroid or visco injections less than three months
    Clear my responses

    How to participate?

    Step 1 Connect with a site
    What happens next?
    • You can expect the study team to contact you via email or phone in the next few days.
    • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

    You are contacting

    Investigator Avatar
    Name

    Primary Contact

    site
    Name

    Phone Email

    0/250
    Please verify that you are not a bot.

    Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

    Learn more

    If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

    Learn more

    Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

    Learn more

    Similar trials to consider

    Loading...

    Not finding what you're looking for?

    Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

    Sign up as volunteer

    user name

    Added by • 

     • 

    Private

    Reply by • Private
    Loading...

    Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

      The passcode will expire in None.
    Loading...

    No annotations made yet

    Add a private note
    • abc Select a piece of text from the left.
    • Add notes visible only to you.
    • Send it to people through a passcode protected link.
    Add a private note