Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2026-01-10 @ 5:43 AM
Study NCT ID:
NCT02539095
Status:
UNKNOWN
Last Update Posted:
2015-09-02
First Post:
2015-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Intra-articular Collagen Injection in Patients With Knee Joint Pain Compared to Normal Saline Injection
Sponsor:
Sewon Cellontech Co., Ltd.
Organization:
Study Overview
Official Title:
A Double-blind, Randomized, Post-marketing Surveillance to Evaluate the Efficacy of Intra-articular Collagen Injection in Patients With Knee Joint Pain Compared to Normal Saline Injection
Status:
UNKNOWN
Status Verified Date:
2015-08
Last Known Status:
ACTIVE_NOT_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:
The primary objective of this study is to confirm the superiority of intra-articular collagen injection in patients with knee joint pain compared to the control group. 100mm VAS is used to measure the pain of the subjects 24 weeks after the procedure.
Detailed Description:
This study is a double-blind clinical trial. Two hundred subjects has participated in it. The study is explained to the subjects, and they voluntarily choose to participate in it. Their eligibility to participate in the study is checked, and they are randomized either into the intra-articular collagen injection group or the normal saline (placebo) injection group based on a randomization table. They are asked to follow the guidelines of the investigators during the study and to visit the hospital five times, including for screening. At each visit, the subjects will undergo an examination with doctors, a medical examination by interview, and a blood test only when it is necessary to evaluate the safety and efficacy of the injection.
(\*If the subjects performed the screening during the first visit on, the total number of his or her additional visits is four.)
(\*If the subjects performed the screening during the first visit on, the total number of his or her additional visits is four.)
Study Oversight
Has Oversight DMC:
True
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?: