Effects of Alpha-1 Antagonist, Stress and Relaxation on Anorectal Functions

Phase 2 Completed 74 enrolled Mayo Clinic National Center for Research Resources (NCRR) · collab National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is designed to better understand the effects of effects of stress, relaxation, and a medication alfuzosin on bowel control and emptying in healthy people and patients with bowel problems.

Timeline

Start: 2013-03
Primary completion: 2017-09-06
Completion: 2017-09-06

Outcome

Missed primary endpoint

registry analysis (superiority test); Constipation Placebo vs Constipation Alfuzosin; p = 0.78; Least squares means NCT01834729 ↗

registry analysis (superiority test); Constipation Placebo vs Constipation Alfuzosin; p = 0.57; Least squares means NCT01834729 ↗

Publications

Results Chakraborty S, Feuerhak K, Muthyala A, Harmsen WS, Bailey KR, Bharucha AE. Effects of Alfuzosin, an alpha1-Adrenergic Antagonist, on Anal Pressures and Bowel Habits in Women With and Without Defecatory Disorders. Clin Gastroenterol Hepatol. 2019 May;17(6):1138-1147.e3. doi: 10.1016/j.cgh.2018.08.036. Epub 2018 Aug 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alfuzosin	Small molecule	10 mg	Oral