CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Pyridostigmine +1 moredrug
Likely dose
Pyridostigmine 60mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00276406
NCT00276406Phase 2Completed
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Pyridostigmine in Diabetics With Constipation: Randomized, Placebo-controlled, Double-blind Trial

Mayo Clinic·interventional·Posted Jan 13, 2006·Updated Nov 30, 2012

In Brief

A Phase 2 clinical trial evaluating Pyridostigmine and Placebo for Constipation and 3 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConstipation, Diabetes Mellitus, Colonic Transit, Gastric Emptying
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Research Resources (NCRR)

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 13, 2006
Enrollment StartMay 1, 2006
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 20.5 years ago

Interventions

Pyridostigminedrug

Pyridostigmine will be started at (60mg) tid, increased over 10 days to 120 mg tid, and maintained at that dose for 7 days.

Placebodrug

If subject is randomized to placebo, placebo pills will be started at (60mg) tid, increased over 10 days to 120 mg tid, and maintained at that dose for 7 days.