ConstipationCTTNCT00857363
Colonic Transit Time Validation Study
An observational study of Constipation, run by The SmartPill Corporation at 13 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Constipation
- How many people
- 210 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Mar 2009to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with constipation referred to a tertiary motility center
Who may be able to join
- 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
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- 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.
- -
Who cannot join
- 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
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- 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%.
- Severe dysphagia to food or pills
- -
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites, 1 recruiting
- Recruiting
University of Michigan Med Center
Ann Arbor, Michigan, 48109
Lina Nahlawi, 734-936-2761, lnahlawi@med.umich.edu
Richard Saad, MD
- Completed
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Completed
University of Buffalo VA Medical Center
Buffalo, New York, 14215
- Completed
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27516
- Completed
University of Iowa
Iowa City, Iowa, 52242
- Completed
Jasper Clinic, Inc.
Kalamazoo, Michigan, 49007
- Completed
University of Kansas Med Center
Kansas City, Kansas, 66160
- Completed
Cedars-Sinai Medical Center
Los Angeles, California, 90048
- Completed
Temple University Medical Center
Philadelphia, Pennsylvania, 19140
- Completed
Mayo Clinic
Rochester, Minnesota, 55905
- Withdrawn
University of Arizona Health and Sciences Ctr Southern Arizona VA HealthCare System
Tucson, Arizona, 85723
- Completed
Wake Forest University Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: SmartPill Colonic Transit Time Validation Study in Patients With Chronic Constipation
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.
Read the detailed description
The primary aim of this study is to assess the equivalence of SP to ROM through characterization of device agreement using SP cutoffs for colonic and whole gut transit (59hrs and 73 hrs respectively) derived from the above mentioned study. The cutoffs are derived from the 95th percentile of the healthy subjects in the study. Demonstration of agreement will also serve to validate these SP cutoffs. Device agreement will be evaluated by comparing the percentage of subjects identified with slow transit versus normal transit with SmartPill to the percentage of subjects identified with slow versus normal transit with ROM in the study population. The colonic transit time results will serve as the primary measure for slow versus normal transit for SmartPill. For ROM test we will employ the Metcalf protocol which provides a measure of whole gut transit to compare the SmartPill results to. Additionally, we will characterize gastric emptying and small bowel transit time of the SmartPill in this population. The SmartPill test will be administered simultaneously with ROM. A modified Metcalf procedure will be employed for characterization of slow transit by ROM.
The SmartPill GI Monitoring System offers an alternative non-invasive method for characterizing disorders of the stomach. The system consists of an ingestible capsule that houses sensors for pH, temperature, and pressure, a receiver for receiving and storing signals from the capsule, and software for displaying data on a personal computer. The capsule samples at regular intervals and transmits the sensed pH, pressure, and temperature data to a portable receiver worn by the subject. After test completion, the recorded data is downloaded to a personal computer for subsequent evaluation. This trial is for subjects 18 years of age to 80 years of age.
- Conditions
- Constipation
- Keywords
- capsule, constipation, whole gut transit, colonic transit, gastric emptying, small bowel transit
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Constipated | Adult subjects with functional constipation as define by Rome II criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonic Transit Time
Measured: 4 days and 7 days
Secondary outcomes (1)
Determine regional gut (gastric, small bowel, colonic) transit times
Measured: continuous time measure until caspule elimination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2009 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The SmartPill Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John R Semler, PHD, Study chair, The SmartPill Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857363
- Sponsor's protocol ID
- 120508
- Acronym
- CTT
- Status last verified
- Jan 2010
- First submitted
- 4 Mar 2009
- Last updated
- 15 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20465593
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SmartPill Colonic Transit Time Validation Study in Patients With Chronic Constipation
- ClinicalTrials.gov ID
- NCT00857363
- Acronym / sponsor ID
- CTT / 120508
- Conditions
- Constipation
- Keywords
- capsule, constipation, whole gut transit, colonic transit, gastric emptying, small bowel transit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- The SmartPill CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- May 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 6 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary aim of this study is to assess the equivalence of SP to ROM through characterization of device agreement using SP cutoffs for colonic and whole gut transit (59hrs and 73 hrs respectively) derived from the above mentioned study. The cutoffs are derived from the 95th percentile of the healthy subjects in the study. Demonstration of agreement will also serve to validate these SP cutoffs. Device agreement will be evaluated by comparing the percentage of subjects identified with slow transit versus normal transit with SmartPill to the percentage of subjects identified with slow versus normal transit with ROM in the study population. The colonic transit time results will serve as the primary measure for slow versus normal transit for SmartPill. For ROM test we will employ the Metcalf protocol which provides a measure of whole gut transit to compare the SmartPill results to. Additionally, we will characterize gastric emptying and small bowel transit time of the SmartPill in this population. The SmartPill test will be administered simultaneously with ROM. A modified Metcalf procedure will be employed for characterization of slow transit by ROM.
The SmartPill GI Monitoring System offers an alternative non-invasive method for characterizing disorders of the stomach. The system consists of an ingestible capsule that houses sensors for pH, temperature, and pressure, a receiver for receiving and storing signals from the capsule, and software for displaying data on a personal computer. The capsule samples at regular intervals and transmits the sensed pH, pressure, and temperature data to a portable receiver worn by the subject. After test completion, the recorded data is downloaded to a personal computer for subsequent evaluation. This trial is for subjects 18 years of age to 80 years of age.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Constipated | – | –Adult subjects with functional constipation as define by Rome II criteria |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with constipation referred to a tertiary motility center
Key inclusion criteria (14 listed)
- 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
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Colonic Transit Time
Time frame: 4 days and 7 days
1 secondary outcome
Determine regional gut (gastric, small bowel, colonic) transit times
Time frame: continuous time measure until caspule elimination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2010.
- Derived from this study: PubMed 20465593Camilleri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John R Semler, PHD study chair
The SmartPill Corporation
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation, run by The SmartPill Corporation at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kelli Regan (716-882-0701 ext. 120, kregan@smartpillcorp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colonic Transit Time (time frame: 4 days and 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00857363, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2010.