deltatrials
Unknown NA INTERVENTIONAL 1-arm NCT03852914

Efficacy and Safety of Intraarticular Sodium Hyaluronate Single Injection in Patients With Osteoarthritis of the Knee

Prospective, Multicentre Study to Evaluate the Efficacy and Safety of Intraarticular Sodium Hyaluronate Single Injection in Patients Suffering From Osteoarthritis of the Knee

Sponsor: Alpha Bioresearch S.L.

Updated 7 times since 2019 Last updated: Feb 27, 2019 Started: Jan 17, 2019 Primary completion: Oct 31, 2019 Completion: Apr 30, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03852914, this NA trial focuses on Osteoarthritis, Knee and remains ongoing. Sponsored by Alpha Bioresearch S.L., it has been updated 7 times since 2019, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

Prospective, multicentre and non-controlled study. Each patient will receive a single injection of SH 2% and will be followed for 1 year with follow up visits at 6 and 12 months At 6 months follow up visit patients will be offered a second injection whenever and when they comply with the criteria established for re-treatment and will be followed for additional 6 months From the pre-inclusion V0 up to the V1 (beginning of treatment), there will be a wash-out period of 2 weeks during which only paracetamol will be allowed for osteoarthritis (OA) pain relief (maximum dose allowed:3g/day). Paracetamol will be discontinued at least 24h before follow up visits (Treatment administration, 6 months of follow up and 12 months of follow up). Clinical evaluation will be done every visits through VAS, WOMAC and Patient's Global Assessment/ Investigator's Global Assessment (PGA/IGA)

Prospective, multicentre and non-controlled study. Each patient will receive a single injection of SH 2% and will be followed for 1 year with follow up visits at 6 and 12 months At 6 months follow up visit patients will be offered a second injection whenever and when they comply with the criteria established for re-treatment and will be followed for additional 6 months From the pre-inclusion V0 up to the V1 (beginning of treatment), there will be a wash-out period of 2 weeks during which only paracetamol will be allowed for osteoarthritis (OA) pain relief (maximum dose allowed:3g/day).

Paracetamol will be discontinued at least 24h before follow up visits (Treatment administration, 6 months of follow up and 12 months of follow up).

Clinical evaluation will be done every visits through VAS, WOMAC and Patient's Global Assessment/ Investigator's Global Assessment (PGA/IGA)

Status Flow

~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshotRecruiting~Apr 2019 – ~Jan 2021 · 21 months · monthly snapshotRecruiting~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshotRecruiting~Oct 2021 – ~Jul 2024 · 33 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotUnknown~Sep 2025 – present · 7 months · monthly snapshotUnknown

Change History

7 versions recorded
  1. Sep 2025 — Present [monthly]

    Unknown NA

  2. Sep 2024 — Sep 2025 [monthly]

    Unknown NA

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown NA

    Status: Unknown StatusUnknown

  4. Oct 2021 — Jul 2024 [monthly]

    Unknown Status NA

    Status: RecruitingUnknown Status

  5. Jan 2021 — Oct 2021 [monthly]

    Recruiting NA

Show 2 earlier versions
  1. Apr 2019 — Jan 2021 [monthly]

    Recruiting NA

  2. Mar 2019 — Apr 2019 [monthly]

    Recruiting NA

    First recorded

Jan 2019

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Alpha Bioresearch S.L.
  • Tedec-Meiji Farma, S.A.
Data source: Tedec-Meiji Farma, S.A.

For direct contact, visit the study record on ClinicalTrials.gov .