Assessment of Whole Gut Transit Time Using the SmartPill Capsule

Constipation Clinical Trial

— WholeGut  

Official title:

Assessment of Whole Gut Transit Time Using the SmartPill Capsule: a Multi-Center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00603707
• Other study ID #: 122205
• Status: Completed
• Phase: Phase 3
• First received: January 8, 2008
• Last updated: August 28, 2008
• Start date: October 2006
• Est. completion date: June 2008

Study information

• Verified date: August 2008
• Source: The SmartPill Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Our null hypothesis states that the two techniques (Sitzmarks radioopaque markers and SmartPill) are equivalent and is demonstrated if the study population shows a correlation of 0.7 or higher.

Description:

The purpose of the study is to measure total gastrointestinal transit time using SmartPill GI Monitoring System with pH.p Capsule and compare the transit time determined by capsule transit to the conventional radioopaque marker technique.

Both techniques are simultaneously applied in normal and constipated adult populations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Males and females between ages of 18-80 years of age with functional constipation that fulfills the Rome II definition of functional constipation

• Bowel movement frequency of < 3 times per week but at least once per two weeks.

• Constipation symptoms for at least 1 year duration.

• Constipation, not abdominal pain, as the primary symptom.

• Ability to stop fiber, laxatives, prokinetic agents, and narcotic analgesic agents 3 days prior to the study and during the 5 day study period.

• Ability to stop proton pump inhibitors 7 days prior to the study and H2RAs for 3 days prior to the study.

Exclusion Criteria:

• 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 > 38

• 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).

• 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 or balloon expulsion test.

• Uncontrolled diabetes with a hemoglobin A1C greater than 10.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Constipation

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	VA Medical Center	Buffalo	New York
United States	University of Iowa	Iowa City	Iowa
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Temple University Medical Center	Philadelphia	Pennsylvania
United States	Mayo Clinic, Scottsdale	Scottsdale	Arizona
United States	Wake Forest University Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
The SmartPill Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	whole gut transit time		2 days and 5 days	No
Secondary	Determine regional gut (gastric, small bowel, colonic) transit times		continuous time measure until caspule elimination	No