Use of Pyridostigmine for Constipation in Diabetics

Phase 1/2 Completed 30 enrolled Mayo Clinic National Center for Research Resources (NCRR) · collab National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

Doctors at Mayo Clinic are doing this study to learn if pyridostigmine, a drug, affects the speed at which food travels through the stomach, intestines and colon, and if pyridostigmine improves constipation symptoms in patients with diabetes. Pyridostigmine has been approved by the Food and Drug Administration (FDA) for routine clinical use, however, its use as proposed in this study is considered investigational.

Timeline

Start: 2006-05
Primary completion: 2010-10
Completion: 2010-10

Outcome

Met primary endpoint

paper pyridostigmine accelerated (1.96 ± 0.18 (baseline), 2.45 ± 0.2 units (treatment), p<0.01) overall colonic transit at 24 h PMID 22677718 ↗

registry analysis (superiority or other test); Pyridostigmine vs Placebo; p <0.01; ANCOVA NCT00276406 ↗

Publications

Results Bharucha AE, Low P, Camilleri M, Veil E, Burton D, Kudva Y, Shah P, Gehrking T, Zinsmeister AR. A randomised controlled study of the effect of cholinesterase inhibition on colon function in patients with diabetes mellitus and constipation. Gut. 2013 May;62(5):708-15. doi: 10.1136/gutjnl-2012-302483. Epub 2012 Jun 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pyridostigmine	Small molecule	120 mg	—