Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00253942
Status:
UNKNOWN
Last Update Posted:
2005-11-15
First Post:
2005-11-10
Brief Title:
Safety and Efficacy Study of Bee Venom to Treat Knee Osteoarthritis
Sponsor:
Rheumatology Therapeutics Medical Center
Organization:
Rheumatology Therapeutics Medical Center
Study Overview
Official Title:
A Randomized Double-Blind Histamine-Controlled Phase 3 Study to Determine the Safety and Efficacy of Bee Venom in the Treatment of Knee Osteoarthritis
Status:
UNKNOWN
Status Verified Date:
2005-10
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Study wishes to determine if the use of injectable bee venom is a safe and effective treatment for persons with mild to moderate knee Osteoarthritis and would result in decreased report of pain and discomfort increased function during daily activities decrease use of analgesic meds and improvement in walking and climbing steps We will be using histamine as a control 40 subjects will be enrolled in a 31 allocation ratio between bee venom and histamine Each injection of bee venom dosage will consist of 100 micrograms of dried bee venom in 01 ml of 05 preservative free Xylocaine The histamine dosage will consist of 0025 milligrams of histamine in 05 preservative free Xylocaine Subjects will visit the study center for 14 visits over an 18 week span The clinical hypothesis is that bee venom is an effective treatment for Osteoarthritis and will reduce pain and discomfort increase range of motion increase daily function decrease walking and stair climbing time and decrease the need of analgesic medication for a period of time beyond treatment after the study has concluded The clinical safety hypothesis is that for persons not allergic to bee venom patients allergic will not be allowed to enter into the study the side effects will be small The most common side effects for bee venom and histamine will be redness and itchiness which will be tolerable and safe
Detailed Description:
None
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