A multicenter, randomized, double-blind, placebo-controlled phase III study of Gel-One in Patients with Hip Osteoarthritis

JRCT ID: jRCT2061240110

Registered date:20/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Osteoarthritis of the Hip
• Date of first enrollment: 18/02/2025
• Target sample size: 200
• Study type: Interventional
• Intervention(s): Subject will be received an intra-articular injection of investigational drug (Gel-One or placebo) administered

Outcome(s)

• Primary Outcome: WOMAC pain subscore Change from baseline

Secondary Outcome

- WOMAC physical funtion subscore
- Patient global evaluation
- OMERACT-OARSI responder
- Daily pain by subject diary
- WOMAC stiffness subscore
- WOMAC total score
- Physician global evaluation
- SF-36 physical component score
- Use of acetaminophen rescue medication

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Patients diagnosed with hip OA
- Patients who have had pain in the target hip due to OA for more than 6 months prior to the date of consent

Exclude criteria

- Patients who have pain in the lower back and lower limbs other than the primary disease that exceeds a certain level during the screening period (7 days before the subject enrollment day)
- Patients who have undergone surgical procedures, including arthroscopy, on the lower limbs and lower back other than the target hip within 6 months prior to the screening test day (excluding joint fluid aspiration). Additionally, patients whose postoperative condition may affect the evaluation of OA in the target hip even after 6 months are excluded
- Patients who have undergone surgical procedures, including arthroscopy, on the target hip (excluding joint fluid aspiration) or who have received PRP therapy on the target hip within one year prior to the screening test day
- Patients who have received intra-articular injections of corticosteroids, Joyclu, or Synvisc into the pain site due to the primary disease within 180 days prior to the screening test day, or intra-articular injections of HA products (such as Artz Dispo) into the pain site due to the primary disease within 28 days prior to the screening test day

Related Information

• Primary Sponsor: Sagawa Kenji