NCT00603707

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2008

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 29, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

August 29, 2008

Status Verified

August 1, 2008

Enrollment Period

1.7 years

First QC Date

January 8, 2008

Last Update Submit

August 28, 2008

Conditions

Constipation

Keywords

capsuleconstipationwhole gut transitcolonic transitgastric emptyingsmall bowel transit

Outcome Measures

Primary Outcomes (1)

  • whole gut transit time

    2 days and 5 days

Secondary Outcomes (1)

  • Determine regional gut (gastric, small bowel, colonic) transit times

    continuous time measure until caspule elimination

Study Arms (2)

Normal

healthy adult subjects with no history or current gastrointestinal disorders or conditions

Constipated

Adult subjects with functional constipation as define by Rome II criteria

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with constipation referred to a tertiary motility center

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Mayo Clinic, Scottsdale

Scottsdale, Arizona, 85259, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

VA Medical Center

Buffalo, New York, 14215, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Temple University Medical Center

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Henry Parkman, MD

    Temple University Medical Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 8, 2008

First Posted

January 29, 2008

Study Start

October 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

August 29, 2008

Record last verified: 2008-08

Locations

US(8)