A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Summary

To evaluate the efficacy on abdominal symptoms (abdominal bloating, abdominal discomfort, and abdominal pain) and safety of linaclotide 290 μg administered orally to patients with IBS-C.

Timeline

Start

2018-06-20

Primary completion

2019-03-13

Completion

2019-04-10

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Linaclotide 290 µg; p < 0.0001; Least squares (LS) mean difference -0.715 (95% CI -0.998 to -0.433); MMRM NCT03573908 ↗

Publications

• Brenner DM, Lacy BE, Ford AC, Bartolini W, Wu J, Shea EP, Bochenek W, Boinpally R, Almansa C. Linaclotide Reduced Response Time for Irritable Bowel Syndrome With Constipation Symptoms: Analysis of 4 Randomized Controlled Trials. Am J Gastroenterol. 2023 May 1;118(5):872-879. doi: 10.14309/ajg.0000000000002064. Epub 2022 Oct 12.
• Chang L, Lacy BE, Moshiree B, Kassebaum A, Abel JL, Hanlon J, Bartolini W, Boinpally R, Bochenek W, Fox SM, Mallick M, Tripp K, Omniewski N, Shea E, Borgstein N. Efficacy of Linaclotide in Reducing Abdominal Symptoms of Bloating, Discomfort, and Pain: A Phase 3B Trial Using a Novel Abdominal Scoring System. Am J Gastroenterol. 2021 Sep 1;116(9):1929-1937. doi: 10.14309/ajg.0000000000001334.

Drugs

Indications