Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-30 @ 8:53 AM
Study NCT ID:
NCT07036003
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-18
First Post:
2025-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recombinant Human Growth Hormone (rHGH) for Knee Osteoarthritis (KORR)
Sponsor:
Dr. David Wasserstein
Organization:
Study Overview
Official Title:
Recombinant Human Growth Hormone (rHGH) for Knee Osteoarthritis (KORR): a Pilot, Randomized Placebo-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KORR
Brief Summary:
The goal of this clinical trial is to see if people with knee osteoarthritis would be willing to comply and adhere to incorporating Recombinant Human Growth Hormone (rHGH), specifically Saizen Somatropin solution, into their treatment plan.
Participants will be asked to:
* Self-inject the treatment solution (placebo or somatropin) into the abdominal or gluteal area once per day for a total of 6 weeks.
* Complete questionnaires related to their knee pain and activities of daily living.
* Provide blood tests.
* Complete various measurements including: circumference of thigh, calf, and abdomen; strength of thigh and knee; range of motion of both knees; and gait analysis.
Participants will be asked to:
* Self-inject the treatment solution (placebo or somatropin) into the abdominal or gluteal area once per day for a total of 6 weeks.
* Complete questionnaires related to their knee pain and activities of daily living.
* Provide blood tests.
* Complete various measurements including: circumference of thigh, calf, and abdomen; strength of thigh and knee; range of motion of both knees; and gait analysis.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: