NCT00857363

Brief 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.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Shorter than P25 for all trials

Geographic Reach
2 countries

13 active sites

Status
unknown

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

March 1, 2009

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

January 15, 2010

Status Verified

January 1, 2010

Enrollment Period

2 months

First QC Date

March 4, 2009

Last Update Submit

January 14, 2010

Conditions

Constipation

Keywords

capsuleconstipationwhole gut transitcolonic transitgastric emptyingsmall bowel transit

Outcome Measures

Primary Outcomes (1)

  • Colonic Transit Time

    4 days and 7 days

Secondary Outcomes (1)

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

    continuous time measure until caspule elimination

Study Arms (1)

Constipated

Adult subjects with functional constipation as define by Rome II criteria

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
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 symptoms of chronic functional constipation for at least one year.
  • Self reported bowel movement frequency of \< 2 bowel movements/week for at least 3 of the last 6 months.
  • 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
  • Constipation, not abdominal pain, as the predominant symptom.
  • Ability to stop laxatives, prokinetic agents, and narcotic analgesic agents 3 days prior to SP and ROM ingestion visit and during the study period.
  • Ability to stop proton pump inhibitors for seven days and Histamine2 blockers for three days prior to and the day of SmartPill ingestion.
  • No evidence of metabolic disease (hypothyroidism, uncontrolled diabetes, electrolyte imbalance).
  • A normal colonoscopy or barium enema within 5 years for individuals over 50 years of age.

You may not qualify if:

  • 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
  • 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 \> 40 kg/m2
  • 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). 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.
  • 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.
  • Uncontrolled diabetes with a hemoglobin A1C greater than 10%.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University of Arizona Health and Sciences Ctr Southern Arizona VA HealthCare System

Tucson, Arizona, 85723, United States

WITHDRAWN

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

COMPLETED

University of Iowa

Iowa City, Iowa, 52242, United States

COMPLETED

University of Kansas Med Center

Kansas City, Kansas, 66160, United States

COMPLETED

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

COMPLETED

University of Michigan Med Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

Jasper Clinic, Inc.

Kalamazoo, Michigan, 49007, United States

COMPLETED

Mayo Clinic

Rochester, Minnesota, 55905, United States

COMPLETED

University of Buffalo VA Medical Center

Buffalo, New York, 14215, United States

COMPLETED

University of North Carolina Medical Center

Chapel Hill, North Carolina, 27516, United States

COMPLETED

Wake Forest University Medical Center

Winston-Salem, North Carolina, 27157, United States

COMPLETED

Temple University Medical Center

Philadelphia, Pennsylvania, 19140, United States

COMPLETED

Queen Mary, University of London

London, United Kingdom

COMPLETED

Related Publications (1)

  • Camilleri M, Thorne NK, Ringel Y, Hasler WL, Kuo B, Esfandyari T, Gupta A, Scott SM, McCallum RW, Parkman HP, Soffer E, Wilding GE, Semler JR, Rao SS. Wireless pH-motility capsule for colonic transit: prospective comparison with radiopaque markers in chronic constipation. Neurogastroenterol Motil. 2010 Aug;22(8):874-82, e233. doi: 10.1111/j.1365-2982.2010.01517.x. Epub 2010 May 11.

    PMID: 20465593DERIVED

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

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

Study Officials

  • John R Semler, PHD

    The SmartPill Corporation

    STUDY CHAIR

Central Study Contacts

Kelli Regan

CONTACT

716-882-0701kregan@smartpillcorp.com

Tracy Crawford

CONTACT

716-882-0701tcrawford@smartpillcorp.com

Study Design

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

Study Record Dates

First Submitted

March 4, 2009

First Posted

March 6, 2009

Study Start

March 1, 2009

Primary Completion

May 1, 2009

Study Completion

June 1, 2009

Last Updated

January 15, 2010

Record last verified: 2010-01

Locations

US(12)GB(1)