Colonic Transit Time Validation Study

• Conditions: Constipation

• Registration Number: NCT00857363
• Lead Sponsor: The SmartPill Corporation

Brief Summary

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.

Detailed Description

The primary aim of this study is to assess the equivalence of SP to ROM through characterization of device agreement using SP cutoffs for colonic and whole gut transit (59hrs and 73 hrs respectively) derived from the above mentioned study. The cutoffs are derived from the 95th percentile of the healthy subjects in the study. Demonstration of agreement will also serve to validate these SP cutoffs. Device agreement will be evaluated by comparing the percentage of subjects identified with slow transit versus normal transit with SmartPill to the percentage of subjects identified with slow versus normal transit with ROM in the study population. The colonic transit time results will serve as the primary measure for slow versus normal transit for SmartPill. For ROM test we will employ the Metcalf protocol which provides a measure of whole gut transit to compare the SmartPill results to. Additionally, we will characterize gastric emptying and small bowel transit time of the SmartPill in this population. The SmartPill test will be administered simultaneously with ROM. A modified Metcalf procedure will be employed for characterization of slow transit by ROM.

The SmartPill GI Monitoring System offers an alternative non-invasive method for characterizing disorders of the stomach. The system consists of an ingestible capsule that houses sensors for pH, temperature, and pressure, a receiver for receiving and storing signals from the capsule, and software for displaying data on a personal computer. The capsule samples at regular intervals and transmits the sensed pH, pressure, and temperature data to a portable receiver worn by the subject. After test completion, the recorded data is downloaded to a personal computer for subsequent evaluation. This trial is for subjects 18 years of age to 80 years of age.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-04
• Study First Submitted QC: 2009-03-05
• Study First Posted: 2009-03-06
• Primary Completion: 2009-05
• Study Completion: 2009-06
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-14
• Last Update Posted: 2010-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. Males and females between ages of 18-80 years of age with symptoms of chronic functional constipation for at least one year.

2. Self reported bowel movement frequency of < 2 bowel movements/week for at least 3 of the last 6 months.

3. 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

4. Constipation, not abdominal pain, as the predominant symptom.

5. Ability to stop laxatives, prokinetic agents, and narcotic analgesic agents 3 days prior to SP and ROM ingestion visit and during the study period.

6. Ability to stop proton pump inhibitors for seven days and Histamine2 blockers for three days prior to and the day of SmartPill ingestion.

7. No evidence of metabolic disease (hypothyroidism, uncontrolled diabetes, electrolyte imbalance).

8. A normal colonoscopy or barium enema within 5 years for individuals over 50 years of age.

Exclusion Criteria

1. 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

2. Previous history of bezoars.

3. Prior GI surgery except for cholecystectomy, appendectomy, or Nissen fundoplication

4. Any abdominal surgery within the past 3 months

5. Known or history of inflammatory bowel disease

6. History of diverticulitis, diverticular stricture, and other intestinal strictures

7. Tobacco use within eight hours prior to capsule ingestion and during the initial 8 hour recording on Day 0 or the Ingestion visit.

8. Alcohol use within eight hours prior to capsule ingestion and throughout the entire monitoring period (5 days).

9. BMI > 40 kg/m2

10. Allergies to components of the SmartBar (Appendix IX).

11. 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.

12. Cardiovascular, endocrine, renal, or other chronic disease likely to affect motility.

13. Use of medical devices such as pacemakers, infusion pumps, or insulin pumps.

14. Any contraindication to use of Fleets Enema.

15. Uncontrolled diabetes with a hemoglobin A1C greater than 10%.

16. Severe dysphagia to food or pills

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Colonic Transit Time	4 days and 7 days

Secondary Outcome Measures

Name	Time	Method
Determine regional gut (gastric, small bowel, colonic) transit times	continuous time measure until caspule elimination

Trial Locations

Locations (13)

Jasper Clinic, Inc.; 🇺🇸 Kalamazoo, Michigan, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Temple University Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of Arizona Health and Sciences Ctr Southern Arizona VA HealthCare System; 🇺🇸 Tucson, Arizona, United States

University of Buffalo VA Medical Center; 🇺🇸 Buffalo, New York, United States

University of Kansas Med Center; 🇺🇸 Kansas City, Kansas, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Wake Forest University Medical Center; 🇺🇸 Winston Salem, North Carolina, United States

Queen Mary, University of London; 🇬🇧 London, United Kingdom

University of Michigan Med Center; 🇺🇸 Ann Arbor, Michigan, United States

University of North Carolina Medical Center; 🇺🇸 Chapel Hill, North Carolina, United States