Colonic Transit Time Validation Study (CTT)

The SmartPill Corporation

Status: Unknown

Conditions: Constipation

Study type: Observational

Funder types: Industry

Identifiers

NCT00857363

120508

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

210 participants in 1 patient group

Constipated

Description:

Adult subjects with functional constipation as define by Rome II criteria