Phase 2 N=40 Other

Evaluation of a PillCam Colon Bowel Preparation Regimen in Crohn's Disease Patients

Crohn's Disease

Bottom Line

View on ClinicalTrials.gov: NCT01576120 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2014

Primary outcome: Primary: • Evaluate the Effectiveness of the PillCam COLON 2 Bowel Prep Regimen in Crohn's Disease Patients — 62; 79 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: bowel prep regimen first boost 6 oz. and second boost 3 oz. (Other); bowel prep regimen first boost 3 oz. and second boost 6 oz. (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medtronic - MITG
Primary completion: Jul 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY • Evaluate the Effectiveness of the PillCam COLON 2 Bowel Prep Regimen in Crohn's Disease Patients	62; 79	—

Summary

The proposed study is designed to evaluate Pillcam regimen in Crohn's disease patients, using the PillCam Colon system.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01576120). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.