Official Title: “Pyridostigmine in Diabetics With Constipation: Randomized, Placebo-Controlled, Double-Blind Trial”

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 Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Pyridostigmine

Primary Measures

• Colonic geometric center at 24 hours (GC24)
• Ascending Colon half-time

Secondary Measures

• Gastric Emptying
• Colonic geometric center at 48 hours (GC48)
• Stool Form/Consistency
• Severity of Constipation
• Ease of Passage

• Thirty (30) men and women with diabetes mellitus (Type I or type II) and constipation.
• Other Inclusion Criteria:Colonoscopy negative for obstructive lesions, cancer, or inflammatory bowel disease within the last 8 years if 50 years of age or older.
• Exclusion Criteria: History of pelvic floor dysfunction (other functional GI disorders, eg
• IBS, non-ulcer dyspepsia are acceptable); Abdominal surgery other than appendectomy, cholecystectomy, hysterectomy, tubal ligation, or inguinal hernia repair; Suspected or known gastrointestinal or genitourinary obstruction; Uncontrolled hypertension (defined as > 150/90 at rest); Known cardiac arrhythmia or ECG abnormalities, i.e. cardiac conduction disturbances (2nd or 3rd degree AV block, prolonged QTc interval (> 460 msec) or bradycardia (< 45 beats/minute)); Renal insufficiency with serum creatinine greater than 2 mg/dl based on a reading from the previous 6 months; Asthma or chronic obstructive pulmonary disease requiring systemic steroids in the previous 3 years (inhaled steroids acceptable); Current use of narcotics, gut prokinetic drugs (eg metoclopramide, domperidone, tegaserod, senekot), anticholinergic medication (eg. Hyoscyamine, belladonna), antidiarrheals (Imodium, Lomotil), or laxatives other than fiber supplements, docusate, or glycerin suppositories. Patients on any of these restricted medications must cease use at least 48 hours before starting and for the duration of both study phases. No rescue laxatives will be permitted within 7 days of transit testing.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Mayo Clinic

Overall Clinical Trial Officials and Contacts

Adil E. Bharucha, M.B.B.S., M.D. Principal Investigator Mayo Clinic  

Information obtained from ClinicalTrials.gov on September 08, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00276406

Study ID Number: 05-004037

ClinicalTrials.gov Identifier: NCT00276406

Health Authority: United States: Institutional Review Board