- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02248337
Low Volume Colon Preparation for IBD
Colon Cleasing for Colonoscopy in Patients With IBD Colitis: Efficacy and Acceptability of 4 Liter PEG vs 2 Liter PEG Plus Bisacodil
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Low-volume preparations are gaining attention for higher acceptability. This study compares efficacy, safety and tolerability of a 2L PEG solution plus bisacodil with a 4L PEG solution in patients with inflammatory bowel disease-related colitis.
This will be a multicenter, randomized, single-blind study. Adult outpatients with IBD colitis undergoing colonoscopy will receive either 2L PEG plus biscodil or 4L PEG. Bowel cleansing will be assessed using the Ottawa Scale and rated as adequate if <6. Patient acceptance, satisfaction, and related symptoms will be also recorded. The study will also focus on the factors affecting quality of preparation in inflammatory bowel disease patients such as disease characteristics and administration regimen
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Milano, Italy, I-20157
- Luigi Sacco University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
-Adult outpatiets with IBD colitis undergoing colonoscopy
Exclusion Criteria:
- Previous colon resection, ileus, intestinal obstruction, toxic megacolon, severe heart failure (NYHA Class III or IV), acute cardiovascular disease, uncontrolled arterial hypertension (systolic pressure >170 mmHg, diastolic pressure >100 mmHg), severe liver cirrhosis (Child-Pugh score C) or renal failure (creatinine clearance<30 mL/minute), ascites, phenylketonuria, and glucose-6-phosphate dehydrogenase deficiency
- Pregnant or breastfeeding women were also excluded
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 4 Liter PEG
Colon preparation for colonoscopy: PEG 4 Liter before endoscopy
|
Colon cleansing prior to perform colonoscopy
Other Names:
|
Experimental: 2 Liter PEG plus bisacodil
Colon preparation for colonoscopy: PEG 2 L before endoscopy
|
Colon cleansing prior to perform colonoscopy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy
Time Frame: During endoscopy within 24 hours after preparation
|
Quality of colon cleansing assesse with Ottawa bowel preparation score
|
During endoscopy within 24 hours after preparation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compliance
Time Frame: during product assumption
|
Intake of at least 75% of the product volume
|
during product assumption
|
Tollerability
Time Frame: during product assumption
|
Occurrence of discomfort during drug intake
|
during product assumption
|
safety
Time Frame: From drug intake to the end of colonoscopy
|
Occurrence of side effects
|
From drug intake to the end of colonoscopy
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: gianpiero manes, MD, AO G. Salvini Garbagnate Milanes
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LOVOL-IBD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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