Clinical trial NCT00857363: Colonic Transit Time Validation Study
Official title: SmartPill Colonic Transit Time Validation Study in Patients With Chronic Constipation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Constipation
Keywords: capsule
constipation
whole gut transit
colonic transit
gastric emptying
small bowel transit
Lead sponsor: The SmartPill Corporation
Sponsor class: INDUSTRY
First posted: 2009-03-06
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with constipation referred to a tertiary motility center

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.

Eligibility criteria: 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.

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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

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Primary outcomes:
measure: Colonic Transit Time
timeFrame: 4 days and 7 days
Secondary outcomes:
measure: Determine regional gut (gastric, small bowel, colonic) transit times
timeFrame: continuous time measure until caspule elimination
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Health and Sciences Ctr Southern Arizona VA HealthCare System
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Med Center
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Med Center
state: Michigan
city: Kalamazoo
country: United States
facility: Jasper Clinic, Inc.
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Buffalo
country: United States
facility: University of Buffalo VA Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Medical Center
state: North Carolina
city: Winston Salem
country: United States
facility: Wake Forest University Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University Medical Center
state: Pennsylvania
city: London
country: United Kingdom
facility: Queen Mary, University of London
Study officials:
affiliation: The SmartPill Corporation
name: John R Semler, PHD
role: STUDY_CHAIR
References:
citation: Camilleri M, Thorne NK, Ringel Y, Hasler WL, Kuo B, Esfandyari T, Gupta A, Scott SM, McCallum RW, Parkman HP, Soffer E, Wilding GE, Semler JR, Rao SS. Wireless pH-motility capsule for colonic transit: prospective comparison with radiopaque markers in chronic constipation. Neurogastroenterol Motil. 2010 Aug;22(8):874-82, e233. doi: 10.1111/j.1365-2982.2010.01517.x. Epub 2010 May 11.