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Efficacy and safety of celecoxib combined with JOINS in the treatment of degenerative knee osteoarthritis: study protocol of a randomized controlled trial

BACKGROUND: The aim of this study will be to investigate the therapeutic effect and safety of non-steroidal anti-inflammatory drugs (NSAIDs) along with symptomatic slow-acting drugs for the treatment of osteoarthritis (SYSADOA), JOINS tablets, for degenerative knee osteoarthritis (OA) treatment and...

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Autores principales: Kim, Man Soo, Koh, In Jun, Sung, Yong Gyu, Park, Dong Chul, Yang, Sung Cheol, In, Yong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8252338/
https://www.ncbi.nlm.nih.gov/pubmed/34262619
http://dx.doi.org/10.1177/1759720X211024025
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author Kim, Man Soo
Koh, In Jun
Sung, Yong Gyu
Park, Dong Chul
Yang, Sung Cheol
In, Yong
author_facet Kim, Man Soo
Koh, In Jun
Sung, Yong Gyu
Park, Dong Chul
Yang, Sung Cheol
In, Yong
author_sort Kim, Man Soo
collection PubMed
description BACKGROUND: The aim of this study will be to investigate the therapeutic effect and safety of non-steroidal anti-inflammatory drugs (NSAIDs) along with symptomatic slow-acting drugs for the treatment of osteoarthritis (SYSADOA), JOINS tablets, for degenerative knee osteoarthritis (OA) treatment and to determine the analgesic and anti-inflammatory effects of the combination therapy. In addition, we will investigate whether JOINS treatment alone after NSAID and JOINS combination treatment is effective in relieving and maintaining knee OA symptoms. METHODS: This study will be a prospective, randomized, double-blind endpoint study design. All patients will be randomly assigned to either intervention (celecoxib+JOINS) or control (celecoxib+placebo) groups. In Part 1, the intervention group will be administered celecoxib once a day and JOINS three times a day for a total of 12 weeks. In the control group, celecoxib will be administered once a day and JOINS placebo three times a day for a total of 12 weeks. In Part 2, JOINS alone and JOINS placebo alone will be administered for an additional 24 weeks in both groups, respectively. The primary endpoint will be the amount of change during the 12 weeks as assessed using the Western Ontario and McMaster Universities Osteoarthritis Index total score compared with baseline. The secondary endpoint will be the amount of change at 1, 4, 12, 24, and 36 weeks from the baseline for pain visual analog scale, Brief Pain Inventory, Short Form Health Survey-36 and biomarkers. RESULTS: The trial was registered with Clinical-Trials.gov (NCT04718649). The clinical trial was also registered on Clinical Research Information Service (CRIS) with the trial registration number KCT0005742. CONCLUSIONS: The combination treatment of the most commonly used SYSADOA drug, JOINS, and selective COX-2 inhibitor celecoxib as the representative NSAID for knee OA treatment, can be compared with celecoxib alone treatment to determine the safety or therapeutic effect.
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spelling pubmed-82523382021-07-13 Efficacy and safety of celecoxib combined with JOINS in the treatment of degenerative knee osteoarthritis: study protocol of a randomized controlled trial Kim, Man Soo Koh, In Jun Sung, Yong Gyu Park, Dong Chul Yang, Sung Cheol In, Yong Ther Adv Musculoskelet Dis Study Protocol BACKGROUND: The aim of this study will be to investigate the therapeutic effect and safety of non-steroidal anti-inflammatory drugs (NSAIDs) along with symptomatic slow-acting drugs for the treatment of osteoarthritis (SYSADOA), JOINS tablets, for degenerative knee osteoarthritis (OA) treatment and to determine the analgesic and anti-inflammatory effects of the combination therapy. In addition, we will investigate whether JOINS treatment alone after NSAID and JOINS combination treatment is effective in relieving and maintaining knee OA symptoms. METHODS: This study will be a prospective, randomized, double-blind endpoint study design. All patients will be randomly assigned to either intervention (celecoxib+JOINS) or control (celecoxib+placebo) groups. In Part 1, the intervention group will be administered celecoxib once a day and JOINS three times a day for a total of 12 weeks. In the control group, celecoxib will be administered once a day and JOINS placebo three times a day for a total of 12 weeks. In Part 2, JOINS alone and JOINS placebo alone will be administered for an additional 24 weeks in both groups, respectively. The primary endpoint will be the amount of change during the 12 weeks as assessed using the Western Ontario and McMaster Universities Osteoarthritis Index total score compared with baseline. The secondary endpoint will be the amount of change at 1, 4, 12, 24, and 36 weeks from the baseline for pain visual analog scale, Brief Pain Inventory, Short Form Health Survey-36 and biomarkers. RESULTS: The trial was registered with Clinical-Trials.gov (NCT04718649). The clinical trial was also registered on Clinical Research Information Service (CRIS) with the trial registration number KCT0005742. CONCLUSIONS: The combination treatment of the most commonly used SYSADOA drug, JOINS, and selective COX-2 inhibitor celecoxib as the representative NSAID for knee OA treatment, can be compared with celecoxib alone treatment to determine the safety or therapeutic effect. SAGE Publications 2021-06-30 /pmc/articles/PMC8252338/ /pubmed/34262619 http://dx.doi.org/10.1177/1759720X211024025 Text en © The Author(s), 2021 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Study Protocol
Kim, Man Soo
Koh, In Jun
Sung, Yong Gyu
Park, Dong Chul
Yang, Sung Cheol
In, Yong
Efficacy and safety of celecoxib combined with JOINS in the treatment of degenerative knee osteoarthritis: study protocol of a randomized controlled trial
title Efficacy and safety of celecoxib combined with JOINS in the treatment of degenerative knee osteoarthritis: study protocol of a randomized controlled trial
title_full Efficacy and safety of celecoxib combined with JOINS in the treatment of degenerative knee osteoarthritis: study protocol of a randomized controlled trial
title_fullStr Efficacy and safety of celecoxib combined with JOINS in the treatment of degenerative knee osteoarthritis: study protocol of a randomized controlled trial
title_full_unstemmed Efficacy and safety of celecoxib combined with JOINS in the treatment of degenerative knee osteoarthritis: study protocol of a randomized controlled trial
title_short Efficacy and safety of celecoxib combined with JOINS in the treatment of degenerative knee osteoarthritis: study protocol of a randomized controlled trial
title_sort efficacy and safety of celecoxib combined with joins in the treatment of degenerative knee osteoarthritis: study protocol of a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8252338/
https://www.ncbi.nlm.nih.gov/pubmed/34262619
http://dx.doi.org/10.1177/1759720X211024025
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