The phase 1/2 trial of indomethacin in chronic pancreatitis (The PAIR trial): Protocol for a parallel multi-center randomized controlled trial

Autor: Samuel Han, Darwin L. Conwell, Liang Li, Alejandra Cervantes, Phil A. Hart, Zobeida Cruz-Monserrate, Wenrui Hao, Gregory B. Lesinski, Thomas Mace, Tonya M. Palermo, Jami L. Saloman, Dhiraj Yadav, Santhi Swaroop Vege, Mark Topazian
Rok vydání: 2023
Předmět:
Zdroj: Pancreatology. 23:42-47
ISSN: 1424-3903
Popis: Current treatments for chronic pancreatitis focus on symptom management and therapeutics targeting disease reversal are lacking. Given the role of the cyclooxygenase-2 (COX-2) enzyme in producing prostaglandin EThis pilot two-center randomized controlled trial seeks to examine 32 subjects with chronic pancreatitis who have no contraindications to indomethacin. Subjects will be randomized to either oral indomethacin 50 mg twice a day or placebo twice a day for a total of 28 days. Baseline (pre-treatment) assessment of pain and quality of life will be performed using the Brief Pain Inventory and the PROMIS-10 questionnaires, respectively. Biological specimens including blood, urine, and saliva will be collected at pre-treatment and post-treatment(day 28). Endoscopic pancreatic function testing with concomitant pancreatic fluid collection will also be performed pre- and post-treatment to assess the change in pancreatic fluid PGEThis study will elucidate the effect of oral indomethacin on PGE
Databáze: OpenAIRE