Osteoarthritis of the Shoulder

  • STATUS
    Recruiting
  • days left to enroll
    60
  • sponsor
    Flexion
Updated on 2 September 2021
body mass index

Summary

The purpose of this study is to evaluate the efficacy on pain and safety of the medication in patients with Glenohumeral or Shoulder Osteoarthritis

Description

Flexion Therapeutics, Inc. is now evaluating a study medication injection for the potential treatment of OA pain in the shoulder. This study may last up to 44 weeks. 

Details
Condition Osteoarthritis, Chronic Shoulder Pain, Glenohumeral Osteoarthritis, Osteoarthritis of the Shoulder
Clinical Study IdentifierTX281510
SponsorFlexion
Last Modified on2 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients 45 to 80 years of age, inclusive, on the day of consent
Body Mass Index (BMI) ≤ 40 kg/m2
Symptoms (including pain) associated with OA of the index shoulder for ≥ 3 months prior to Screening visit

Exclusion Criteria

Inability to undergo MRI due to presence of surgical hardware or other foreign body in the index shoulder
Females who are pregnant or nursing or plan to become pregnant within 12 months after dosing; men who plan to conceive within 12 months after dosing
Laboratory evidence of infection with human immunodeficiency virus (HIV), positive test for hepatitis B surface antigen (HBsAg) or positive serology for hepatitis C virus (HCV) with positive test for HCV Ribonucleic acid (RNA)
History of or active Cushing’s syndrome
Active or history of malignancy within 5 years of Screening, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or effectively managed cervical carcinoma
History of radiation treatment involving the index shoulder girdle
Active substance abuse (drugs or alcohol) or history of substance abuse within the past 12 months of Screening
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Step 1 Connect with a study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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.

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

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