Opioid-Induced Constipation: A Case Study

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The purpose of this study was to determine the safety and tolerability of naloxegol in patients who experience opioid-induced constipation (OIC) and suffer from noncancer pain. This was done through a phase 3 clinical trial that was performed over 52 weeks and across multiple centers with parallel groups. The trial was open-labeled, and patients were randomized 2:1 to receive either naloxegol 25 mg once daily or the usual care treatment regimen prescribed by the investigator at his discretion. The patients ranged from ages 18-65 years old and were receiving 30-1000 morphine-equivalent units (MEUs) with confirmed OIC over a 2-week period. 327 out of the 563 patients (58%) in the naloxegol group completed the study, and 189 out of the 281 patients (67%) in the usual care group completed the study. The primary objective of this study was the safety and tolerability of naloxegol, and the secondary objective of this study was the safety profile of naloxegol compared to the usual care laxative regimen. …show more content…

In the naloxegol group, 81.8% of patients experienced an adverse event (AE), 9.6% experienced a serious AE, and 10.5% experienced an AE that resulted in discontinuation of the product. In the usual care group, 72.2% of patients experienced an AE, and 11.1% experienced a serious AE. In this group, patients could switch to a different usual care treatment option at any time during the study, so data for discontinuation due to AE is not applicable. It was determined that there needed to be over 300 patients in the naloxegol group and over 100 patients in the usual care group. Both of these requirements were

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