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http://dspace.zsmu.edu.ua/handle/123456789/22030
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Название: | A Randomized Controlled Phase 2 Dose-Finding Trial to Evaluate the Efficacy and Safety of Camostat in the Treatment of Painful Chronic Pancreatitis: The TACTIC Study |
Авторы: | Hart, Phil. A. Osypchuk, Yu. Hovbakh, I. Shah, R. J. Nieto, J. Cote, G. A. Avgaitis, S. Kremzer, O. Buxbaum, J. Inamdar, S. Fass, R. Phillips, R. W. Yadav, D. Ladd, A. M. Al-Assi, M. T. Gardner, T. Conwell, D. L. Irani, S. Sheikh, A. Nuttall, J. Кремзер, Олександр Олександрович |
Ключевые слова: | Serine Protease Inhibitor Analgesia Morbidity Quality of Life |
Дата публикации: | 2024 |
Библиографическое описание: | A Randomized Controlled Phase 2 Dose-Finding Trial to Evaluate the Efficacy and Safety of Camostat in the Treatment of Painful Chronic Pancreatitis: The TACTIC Study / Phil. A. Hart, Yu. Osypchuk, I. Hovbakh, R. J. Shah, J. Nieto, G. A. Cote, S. Avgaitis, O. Kremzer, J. Buxbaum, S. Inamdar, R. Fass, R. W. Phillips, D. Yadav, A. M. Ladd, M. T. Al-Assi, T. Gardner, D. L. Conwell, S. Irani, A. Sheikh, J. Nuttall, // Gastroenterology. - 2024. - Vol. 166, Iss. 4. - P. 658-666. - Published:December 14, 2023. - https://doi.org/10.1053/j.gastro.2023.12.008. |
Аннотация: | BACKGROUND & AIMS: Chronic pancreatitis (CP) causes an
abdominal pain syndrome associated with poor quality of life.
We conducted a clinical trial to further investigate the efficacy
and safety of camostat, an oral serine protease inhibitor that
has been used to alleviate pain in CP. METHODS: This was a
double-blind randomized controlled trial that enrolled adults
with CP with a baseline average daily worst pain score 4 on a
numeric rating system. Participants were randomized (1:1:1:1)
to receive camostat at 100, 200, or 300 mg 3 times daily or
placebo. The primary end point was a 4-week change from
baseline in the mean daily worst pain intensity score (0–10 on a
numeric rating system) using a mixed model repeated measure
analysis. Secondary end points included changes in alternate
pain end points, quality of life, and safety. RESULTS: A total of
264 participants with CP were randomized. Changes in pain
from baseline were similar between the camostat groups and
placebo, with differences of least squares means of –0.11 (95%
CI, –0.90 to 0.68), –0.04 (95% CI, –0.85 to 0.78), and –0.11
(95% CI, –0.94 to 0.73) for the 100 mg, 200 mg, and 300 mg
groups, respectively. Multiple subgroup analyses were similar
for the primary end point, and no differences were observed in
any of the secondary end points. Treatment-emergent adverse
events attributed to the study drug were identified in 42 participants
(16.0%). CONCLUSION: We were not able to reject the
null hypothesis of no difference in improvements in pain or
quality of life outcomes in participants with painful CP who
received camostat compared with placebo. Studies are needed
to further define mechanisms of pain in CP to guide future
clinical trials, including minimizing placebo responses and
selecting targeted therapies. |
URI: | http://dspace.zsmu.edu.ua/handle/123456789/22030 |
Располагается в коллекциях: | Наукові праці. (Клінічна фармакологія)
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