Crohn's DiseasePhase 1/2RD-207NCT01576120
Evaluation of a PillCam Colon Bowel Preparation Regimen in Crohn's Disease Patients
A Phase 1/2 study testing bowel prep regimen first boost 6 oz. and second boost 3 oz. and bowel prep regimen first boost 3 oz. and second boost 6 oz. in people with Crohn's Disease, run by Medtronic - MITG at 2 sites in United States.
Trial summary
The proposed study is designed to evaluate Pillcam regimen in Crohn's disease patients, using the PillCam Colon system. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- bowel prep regimen first boost 6 oz. and second boost 3 oz. and bowel prep regimen first boost 3 oz. and second boost 6 oz.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2012to Jul 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 18 years of age and above
- Subjects who are determined by their physician to have active Crohn's disease based on at least one of the following tests which were performed in the past 3 months :
- Colonoscopy
- Capsule endoscopy of the small bowel or colon
- Other radiology tests
- Clinical symptoms with elevated positive inflammatory markers ;ESR, CRP, thrombocytosis, leukocytosis, fecal lactoferrin, or fecal alpha-1 antitrypsin
- Proven patency by the Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, performed within the 3 months prior to enrollment
- Subject is able and agrees to sign the Informed Consent Form
Who cannot join
- • Subject has dysphagia
- Subject has congestive heart failure
- Subject has renal insufficiency
- Subject has cirrhosis
- Subject is known or is suspected to suffer from intestinal obstruction
- Subject has known previous stricture/obstruction of the SB or colon
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- Chronic use of laxatives
- Subject has a cardiac pacemaker or other implanted electro medical device.
- Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
- Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
- Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
- Subject has any condition, which precludes compliance with study and/or device instructions.
- Subject suffers from life threatening conditions
- Subject is currently participating in another clinical study
- Subject has known slow gastric emptying time or GI transit time.
- Subject is allergic or contraindicated to any of the study medications
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342
Dayton Gastroenterology
Beavercreek, Ohio, 45440
About this study
Official title: Evaluation of a PillCam Colon Bowel Preparation Regimen in Crohn's Disease Patients- Pivotal Study
The proposed study is designed to evaluate Pillcam regimen in Crohn's disease patients, using the PillCam Colon system.
Read the detailed description
- Primary Scientific Objective Evaluate the effectiveness of the PillCam COLON 2 Prep Regimen in CD patients. Secondary Objective To evaluate safety of the PillCam™ COLON 2 procedure in CD patients
- Study Hypothesis Crohn's Disease may be pan-enteric in nature and can affect the small bowel, the colon or both. PillCam COLON 2 may be used for visualization of both SB and colon mucosa in Crohn's Disease patients. However, bowel prep is required in order to evacuate all fecal matter prior to the exam and in order to propel the capsule and complete its traverse through the entire GI track within examination time.
- The study is designed to evaluate the effectiveness of the prep regimen in terms of transit, excretion and cleansing in CD patients
All end points will be evaluated within 4 months from end of enrollment.
- Conditions
- Crohn's Disease
- Being tested
- bowel prep regimen first boost 6 oz. and second boost 3 oz., bowel prep regimen first boost 3 oz. and second boost 6 oz.
- Keywords
- Known, active Crohn's disease, Iieocolonic or colonic involvement, proven patency of the GI tract
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bowel prep regimen first boost 6 oz. and second boost 3 oz.Other
Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)
bowel prep regimen first boost 3 oz. and second boost 6 oz.Other
Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)
| Study group | Role | What they receive |
|---|---|---|
| bowel prep regimen first boost 6 oz. and second boost 3 oz. | Experimental | 4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI Receives: Other: bowel prep regimen first boost 6 oz. and second boost 3 oz. |
| bowel prep regimen first boost 3 oz. and second boost 6 oz. | Experimental | 4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI Receives: Other: bowel prep regimen first boost 3 oz. and second boost 6 oz. |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Evaluate the Effectiveness of the PillCam COLON 2 Bowel Prep Regimen in Crohn's Disease Patients
effectiveness of the PillCam COLON 2 bowel prep regimen in Crohn's Disease patients will be evaluated by the folloiwng: • Bowel preparation cleansing level assessment
The duration of the procedure in this study is 1 day of colon preparation and
1 day of Capsule Endoscopy (CE) procedure. 5-9 days after the CE procedure a follow up call to the subjects will be conducted.
Measured: The end points and outcomes measures will be evaluated within 4 months from end of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576120
- Sponsor's protocol ID
- RD-207
- Acronym
- RD-207
- Status last verified
- Oct 2014
- First submitted
- 5 Apr 2012
- Last updated
- 8 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a PillCam Colon Bowel Preparation Regimen in Crohn's Disease Patients- Pivotal Study
- ClinicalTrials.gov ID
- NCT01576120
- Acronym / sponsor ID
- RD-207 / RD-207
- Conditions
- Crohn's Disease
- Keywords
- Known, active Crohn's disease, Iieocolonic or colonic involvement, proven patency of the GI tract
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 12 Apr 2012 (estimated)
- Results
- Posted 9 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is designed to evaluate Pillcam regimen in Crohn's disease patients, using the PillCam Colon system.
Detailed description
- Primary Scientific Objective Evaluate the effectiveness of the PillCam COLON 2 Prep Regimen in CD patients. Secondary Objective To evaluate safety of the PillCam™ COLON 2 procedure in CD patients
- Study Hypothesis Crohn's Disease may be pan-enteric in nature and can affect the small bowel, the colon or both. PillCam COLON 2 may be used for visualization of both SB and colon mucosa in Crohn's Disease patients. However, bowel prep is required in order to evacuate all fecal matter prior to the exam and in order to propel the capsule and complete its traverse through the entire GI track within examination time.
- The study is designed to evaluate the effectiveness of the prep regimen in terms of transit, excretion and cleansing in CD patients
All end points will be evaluated within 4 months from end of enrollment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bowel prep regimen first boost 6 oz. and second boost 3 oz. | Experimental | Other: bowel prep regimen first boost 6 oz. and second boost 3 oz.4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI |
| bowel prep regimen first boost 3 oz. and second boost 6 oz. | Experimental | Other: bowel prep regimen first boost 3 oz. and second boost 6 oz.4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is 18 years of age and above
Key exclusion criteria (16 listed)
- • Subject has dysphagia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bowel prep regimen first boost 6 oz. and second boost 3 oz.Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost) | Other | bowel prep regimen first boost 6 oz. and second boost 3 oz. |
| bowel prep regimen first boost 3 oz. and second boost 6 oz.Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost) | Other | bowel prep regimen first boost 3 oz. and second boost 6 oz. |
Primary outcome
• Evaluate the Effectiveness of the PillCam COLON 2 Bowel Prep Regimen in Crohn's Disease Patients
Time frame: The end points and outcomes measures will be evaluated within 4 months from end of enrollment
effectiveness of the PillCam COLON 2 bowel prep regimen in Crohn's Disease patients will be evaluated by the folloiwng: • Bowel preparation cleansing level assessment The duration of the procedure in this study is 1 day of colon preparation and 1 day of Capsule Endoscopy (CE) procedure. 5-9 days after the CE procedure a follow up call to the subjects will be conducted.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing bowel prep regimen first boost 6 oz. and second boost 3 oz. and bowel prep regimen first boost 3 oz. and second boost 6 oz. in people with Crohn's Disease, run by Medtronic - MITG at 2 sites in United States.
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 8 inclusion and 16 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: finished, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Evaluate the Effectiveness of the PillCam COLON 2 Bowel Prep Regimen in Crohn's Disease Patients (time frame: The end points and outcomes measures will be evaluated within 4 months from end of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2019.