Study to Evaluate the Efficacy and Safety of FX006 in Patients With Glenohumeral Osteoarthritis o… (NCT04160091) | Clinical Trial Compass
TerminatedPhase 2
Study to Evaluate the Efficacy and Safety of FX006 in Patients With Glenohumeral Osteoarthritis or Shoulder Adhesive Capsulitis
Stopped: The study was terminated prematurely due to the COVID-19 pandemic creating uncertainty impacting trial progress and costs.
United States19 participantsStarted 2019-11-07
Plain-language summary
This is a double-blind study to evaluate the efficacy and safety of FX006 in patients with glenohumeral osteoarthritis (OA) or shoulder adhesive capsulitis (AC).
Who can participate
Age range35 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Glenohumeral OA:
* Male or female, 35 to 80 years of age, inclusive, on the day of consent.
* Painful symptoms associated with OA of the index glenohumeral joint for ≤3 months prior to the Screening Visit.
* Grade 2 or 3 OA in the index glenohumeral joint based on the Samilson-Prieto classification system as confirmed by X-ray (axillary view and true anterior-posterior view) taken at the Screening Visit.
Shoulder AC:
* Male or female, 35 to 80 years of age, inclusive, on the day of consent.
* Pain associated with AC of the index joint for ≥1 month but ≤ 6 months prior to the Screening Visit.
* Limitations on both active and passive ROM ≥25% in at least 2 directions (e.g., forward flexion, abduction, and internal and external rotation assessed in a standardized protocol) compared with the contralateral shoulder or with normal values.
* No X-ray evidence of OA of the index shoulder (axillary view and true anterior-posterior view) at the Screening Visit.
* Agrees to complete a standardized, protocol-specified shoulder Home Exercise Program (HEP) starting 3 days after injection until the End of Study (EOS) Visit.
Both:
* Written consent to participate in the study
* Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions
* (BMI) ≤ 40 kg/m2
* Average daily mean shoulder pain with movement score ≥5.0 and ≤9.0 in the index shoulder (0 to 10 NRS) using the average daily ratings for at least …
What they're measuring
1
Area Under the Curve of the Change From Baseline in the Weekly Mean of the Daily Shoulder Pain With Movement