IRB Number:

05-004037

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

The purpose of this research study is 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.

Who is Eligible to Participate in the Study?

Men and women between the ages of 18 and 70 with diabetes mellitus (Type I or type II) and constipation may be eligible to particiapate in this research study.

What is Involved With this Study?

After completing a baseline/screening phase, participants will be put in one of 2 groups by chance (as in the flip of a coin). One group will receive 17 days of Pyridostigmine pills to take by mouth, and one group will receive 17 days of Placebo (a sugar pill with no active drug). Participants will not know which group they are in. They will be given the medication to take home with them after the first transit test.

The first 10 days of taking the medication is called the Drug Ramp period. During this time participants will slowly increase the number of study pills that are taken. They will start with one pill 3 times a day. Every 3rd day, participants will add another pill according to the schedule that is given to them.

How long will the Study run?

Participants will be in the study for 24 days total. A period of up to 16 days is allowed between the Baseline and Medication Phase to fit this study into a participants schedule.

Who can I Contact for Additional Information on this Trial?

For more information or to participate in this research study, please contact Barb Seide at (507) 255-6802 or Dr. Adil E. Bharucha at (507) 284-2687.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 09/27/2007