Expired Study
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Boston, Massachusetts 02114


Purpose:

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.


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

122205


NCT ID:

NCT00603707


Secondary ID:


Study Acronym:

WholeGut


Brief Title:

Assessment of Whole Gut Transit Time Using the SmartPill Capsule


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The SmartPill Corporation


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case Control, Time Perspecti


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

178


Enrollment Type:

Actual


Overall Contact Information

Official Name:Henry Parkman, MD
Study Chair
Temple University Medical Center

Study Dates

Start Date:October 2006
Completion Date:June 2008
Completion Type:Actual
Primary Completion Date:June 2008
Primary Completion Type:Actual
Verification Date:August 2008
Last Changed Date:August 28, 2008
First Received Date:January 8, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Determine regional gut (gastric, small bowel, colonic) transit times
Time Frame:continuous time measure until caspule elimination
Safety Issues:False
Outcome Type:Primary Outcome
Measure:whole gut transit time
Time Frame:2 days and 5 days
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Constipated
Description:Adult subjects with functional constipation as define by Rome II criteria
Study Arm Type:Other
Arm Name:Normal
Description:healthy adult subjects with no history or current gastrointestinal disorders or conditions

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:The SmartPill Corporation

Samples and Retentions

Study Population: patients with constipation referred to a tertiary motility center
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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