Recruiting

Colonic Transit Time

Sponsor:

The SmartPill Corporation

Code:

NCT00857363

Conditions

Constipation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Constipation

Study ID

NCT00857363

Start date

Mar, 2009

Status verified date

Jan, 2010

Completion date

Jun, 2009

Anticipated

Primary completion date

May, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

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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

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Study Design

Enrollment

210 participants

Anticipated

Interventions and Outcome Measures

Arms

Constipated

Adult subjects with functional constipation as define by Rome II criteria

Primary outcome measure

  • Colonic Transit Time [ Time Frame: 4 days and 7 days ]

Central Contacts and Locations

Locations

University of Michigan Med Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Principal Investigator:

Richard Saad, MD

More Information

Sponsor

The SmartPill Corporation

Last update posted

Jan 15, 2010

Last verified

Jan, 2010

Keywords

  • capsule
  • constipation
  • whole gut transit
  • colonic transit
  • gastric emptying
  • small bowel transit

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The SmartPill Corporation on 2010-01-15.