Effectiveness and Safety of Celecoxib (Celebrex 200 mg) Combined With Joins in the Treatment of Degenerative Knee Osteoarthritis: a Randomized Controlled Trial

Summary

Participation Requirements

Description

The Investigators will conduct research to patients with outpatient treatment for osteoarthritis of the knee joint, pain control will be performed using the same pain control technique that is generally applied to patients with osteoarthritis of the knee joint. The enrolled patienst will be divided ...

The Investigators will conduct research to patients with outpatient treatment for osteoarthritis of the knee joint, pain control will be performed using the same pain control technique that is generally applied to patients with osteoarthritis of the knee joint. The enrolled patienst will be divided into the group taking celecoxib 200mg with Joins tab together and the group taking celecoxib 200mg with Joins placebo in the same probability of 2:1 according to the randomization table at the first outpatient visit. Among the co-researchers, one researcher who is in charge of patient assignment will create a randomization table through computer generated randomization. And this researcher who is charge of the patient assignment will not intervene in any other process of this study, and only participates in the task of selecting the assigned group using random checks. The evaluation will be evaluated by an researcher who is not aware of the patient allocation according to the randomization table among researchers participating in the clinical study. Such a study plan will be fully explained to the patient in the process of seeking consent for the study before discharge, as it is recorded in detail in the subject description, and only patients who have obtained consent for this will be the subject of the study. Subjects assigned through randomization are prescribed and taken through the clinical pharmacy. Considering that Joins tab is a sustained-acting drug, the study is divided into Celebrex + Joins placebo group and Celebrex + Joins tab group for up to 12 weeks, and only Joins placeb and Joins are taken for weeks 12th week to 36th week except for celebrex. The total period of the study should be 36 weeks. In the case of the rescue drug, 650mg of Tylenol sustained-release tablet (acetaminophen) in both groups can be taken up to 3 tablets per day, and up to 36 weeks of taking the test drug. Patients should follow the approved usage and dosage, and taking relief drug is prohibited within 1 day before the regular visit. Relief drugs will be prescribed at baseline and from subsequent visits, if necessary, according to the judgment of the investigator. At the first visit, at 4 weeks, 12 weeks, 24 weeks, 36 weeks, the degree of pain will be measured using the VAS pain scale, and additional pain scale using the WOMAC pain scale, Brief pain inventory (BPI), and SF-36 score. Knee X-rays will be taken at each outpatient visit as the knee degenerative osteoarthritis patients are measured to check joint space width (JSW) and Kellgren-Lawrence grade to objectively evaluate the effectiveness and stability of the medication effect.

Tracking Information