Colonic Transit Time Validation Study

Status unconfirmed

Conditions studied: Constipation

In brief

The protocol described herein is designed to provide clinical evidence of the substantial equivalence of SmartPill GI Monitoring System (SP) to the Sitzmarks (Konsyl Pharmaceuticals, Easton, MD) radio-opaque markers (ROM). The trial will enroll symptomatic subjects who meet Rome III criteria (1) for chronic functional constipation.

Key facts

Study ID

NCT00857363

Run by

The SmartPill Corporation

People needed

210

Starts

2009-03-01

Expected to finish

2009-06-01

Last updated by the study team

2010-01-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females between ages of 18-80 years of age with symptoms of chronic functional constipation for at least one year.
• Self reported bowel movement frequency of < 2 bowel movements/week for at least 3 of the last 6 months.
• Presenting at least one of the following symptoms as defined by Rome III criteria
• Feeling of incomplete evacuation with > 25% of bowel movements
• Digital maneuvers with > 25% of bowel movements
• Hard stools with > 25% of bowel movements
• Feeling of blockage with > 25% of bowel movements
• Straining with > 25% of bowel movements
• Constipation, not abdominal pain, as the predominant symptom.
• Ability to stop laxatives, prokinetic agents, and narcotic analgesic agents 3 days prior to SP and ROM ingestion visit and during the study period.
• Ability to stop proton pump inhibitors for seven days and Histamine2 blockers for three days prior to and the day of SmartPill ingestion.
• No evidence of metabolic disease (hypothyroidism, uncontrolled diabetes, electrolyte imbalance).
• A normal colonoscopy or barium enema within 5 years for individuals over 50 years of age.

You may not qualify if…

• Participation in the previous SmartPill Whole gut transit Study titled "Assessment of Whole Gut Transit Time Using the SmartPill Capsule: A Multicenter Study" Protocol Number 122205
• Previous history of bezoars.
• Prior GI surgery except for cholecystectomy, appendectomy, or Nissen fundoplication
• Any abdominal surgery within the past 3 months
• Known or history of inflammatory bowel disease
• History of diverticulitis, diverticular stricture, and other intestinal strictures
• Tobacco use within eight hours prior to capsule ingestion and during the initial 8 hour recording on Day 0 or the Ingestion visit.
• Alcohol use within eight hours prior to capsule ingestion and throughout the entire monitoring period (5 days).
• BMI > 40 kg/m2
• Allergies to components of the SmartBar (Appendix IX).
• Females of childbearing age who are not practicing birth control and/or are pregnant or lactating. (A urine pregnancy test will be performed on female subjects prior to capsule ingestion). Acceptable forms of birth control include oral contraceptives, double barrier method, and IUD cover and must be practiced from the time of enrollment until the time of release from the study.
• Cardiovascular, endocrine, renal, or other chronic disease likely to affect motility.
• Use of medical devices such as pacemakers, infusion pumps, or insulin pumps.
• Any contraindication to use of Fleets Enema.
• Uncontrolled diabetes with a hemoglobin A1C greater than 10%.
• Severe dysphagia to food or pills

Where it is running

• University of Michigan Med Center — Ann Arbor, Michigan, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Kansas Med Center — Kansas City, Kansas, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Jasper Clinic, Inc. — Kalamazoo, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• University of Buffalo VA Medical Center — Buffalo, New York, United States
• University of North Carolina Medical Center — Chapel Hill, North Carolina, United States
• Wake Forest University Medical Center — Winston-Salem, North Carolina, United States
• Temple University Medical Center — Philadelphia, Pennsylvania, United States
• University of Arizona Health and Sciences Ctr Southern Arizona VA HealthCare System — Tucson, Arizona, United States
• Queen Mary, University of London — London, United Kingdom

Full record on ClinicalTrials.gov

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