Colonic Transit Time Validation Study

Constipation Clinical Trial

— CTT  

Official title:

SmartPill Colonic Transit Time Validation Study in Patients With Chronic Constipation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00857363
• Other study ID #: 120508
• Status: Recruiting
• Phase: N/A
• First received: March 4, 2009
• Last updated: January 14, 2010
• Start date: March 2009
• Est. completion date: June 2009

Study information

• Verified date: January 2010
• Source: The SmartPill Corporation
• Contact: Kelli Regan
• Phone: 716-882-0701
• Email: kregan[@]smartpillcorp.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Constipation

Locations

Country	Name	City	State
United Kingdom	Queen Mary, University of London	London
United States	University of Michigan Med Center	Ann Arbor	Michigan
United States	Massachusetts General Hospital	Boston	Massachusetts
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	University of Iowa	Iowa City	Iowa
United States	Jasper Clinic, Inc.	Kalamazoo	Michigan
United States	University of Kansas Med Center	Kansas City	Kansas
United States	Cedars-Sinai Medical Center	Los Angeles	California
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	Wake Forest University Medical Center	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
The SmartPill Corporation

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colonic Transit Time		4 days and 7 days	No
Secondary	Determine regional gut (gastric, small bowel, colonic) transit times		continuous time measure until caspule elimination	No