Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528600
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-05-08
Brief Title:
Comparative Study of Two Hyaluronic Acid Formulation in the Management of Knee Osteoarthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-Blind Active Controlled Multi-Center Non- Inferiority Study of One-injection of Hymovis ONE 32 mg4ml Against Currently Approved 1-injection Regimen of Monovisc in Symptomatic Relief of Osteoarthritis of the Knee
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this randomized double-blind active-controlled non-inferiority study is to compare the effectiveness and safety of a single injection of Hymovis ONE a sodium hyaluronate formulation to Monovisc another sodium hyaluronate formulation for the treatment of pain from osteoarthritis OA of the knee in patients who have not responded to non-pharmacological therapies or analgesic regimens This study consists of a 2-week period for screening one baseline treatment visit and a 26- week evaluation phase Subjects will be randomized to receive a single intra-articular IA injection of either Hymovis ONE or Monovisc into the knee using an 18-20 gauge needle
Detailed Description:
This is a multi-center randomized double-blind active comparator-controlled non-inferiority study to assess the efficacy and safety of a single injection of Hymovis ONE for the relief of pain in subjects with OA of the knee by establishing its non-inferiority to Monovisc
The entire study will last approximately 19 months Patients will participate in the study for approximately 28 weeks from screening to the last visit
The study is designed to compare the effectiveness and safety of a single injection of Hymovis ONE to a single injection of Monovisc Both products are high molecular weight HA preparations specifically sodium hyaluronate from bacterial fermentation supplied sterile as a single dose of 4 ml in a 5 ml syringe
Subjects will undergo an evaluation consisting of a thorough discussion of medical history demographics followed by a physical examination and vital signs blood pressure and heart rate measurement
The evaluation of their activity level through the Tegner activity level scale a graduated list of ADLs recreation and competitive sports will be performed The patient is asked to select the level of participation that best describes their current level of activity through an Investigators interview The Tegner activity level scale is filled in by Investigator
In this study one single IA injection of Hymovis ONE or Monovisc will be performed at the investigational site under the tight supervision of an experienced treating specialist Therefore there are no expected risks of misuse in the administration of the investigational products according to treatment schedule defined in the study protocol Furthermore the use of only one IA injection should further contribute to limit the risk of adverse effects Therefore it is expected that benefits from participation in this study will outweigh the potential risks
The entire study will last approximately 19 months Patients will participate in the study for approximately 28 weeks from screening to the last visit
The study is designed to compare the effectiveness and safety of a single injection of Hymovis ONE to a single injection of Monovisc Both products are high molecular weight HA preparations specifically sodium hyaluronate from bacterial fermentation supplied sterile as a single dose of 4 ml in a 5 ml syringe
Subjects will undergo an evaluation consisting of a thorough discussion of medical history demographics followed by a physical examination and vital signs blood pressure and heart rate measurement
The evaluation of their activity level through the Tegner activity level scale a graduated list of ADLs recreation and competitive sports will be performed The patient is asked to select the level of participation that best describes their current level of activity through an Investigators interview The Tegner activity level scale is filled in by Investigator
In this study one single IA injection of Hymovis ONE or Monovisc will be performed at the investigational site under the tight supervision of an experienced treating specialist Therefore there are no expected risks of misuse in the administration of the investigational products according to treatment schedule defined in the study protocol Furthermore the use of only one IA injection should further contribute to limit the risk of adverse effects Therefore it is expected that benefits from participation in this study will outweigh the potential risks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None