Prevention of Recurrence of Diverticulitis

Summary

The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.

Timeline

Start

2007-12-06

Primary completion

2011-11-28

Completion

2011-11-28

Outcome

Missed primary endpoint

registry analysis (unspecified test); SPD476 (4.8 g) vs Placebo; p = 0.778; Cochran-Mantel-Haenszel NCT00545103 ↗

paper CONCLUSIONS: Mesalamine was not superior to placebo in preventing recurrent diverticulitis. PMID 25038431 ↗

Publications

• Raskin JB, Kamm MA, Jamal MM, Marquez J, Melzer E, Schoen RE, Szaloki T, Barrett K, Streck P. Mesalamine did not prevent recurrent diverticulitis in phase 3 controlled trials. Gastroenterology. 2014 Oct;147(4):793-802. doi: 10.1053/j.gastro.2014.07.004. Epub 2014 Jul 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mesalamine	Small molecule	1.2 g	—
Subject	Mesalamine	Small molecule	2.4 g	—
Subject	Mesalamine	Small molecule	4.8 g	—

Indications