Low Volume Colon Preparation for IBD

Inflammatory Bowel Disease Clinical Trial

Official title:

Colon Cleasing for Colonoscopy in Patients With IBD Colitis: Efficacy and Acceptability of 4 Liter PEG vs 2 Liter PEG Plus Bisacodil

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02248337
• Other study ID #: LOVOL-IBD
• Status: Completed
• Phase: Phase 4
• First received: September 20, 2014
• Last updated: September 23, 2014
• Start date: March 2013
• Est. completion date: March 2014

Study information

• Verified date: September 2014
• Source: Luigi Sacco University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Comparison of two PEG-based bowel cleansing regimens in patients with inflammatory bowel disease.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Drug:
• Colon preparation for colonoscopy
Colon cleansing prior to perform colonoscopy

Locations

Country	Name	City	State
Italy	Luigi Sacco University Hospital	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Luigi Sacco University Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	Quality of colon cleansing assesse with Ottawa bowel preparation score	During endoscopy within 24 hours after preparation	No
Secondary	Compliance	Intake of at least 75% of the product volume	during product assumption	No
Secondary	Tollerability	Occurrence of discomfort during drug intake	during product assumption	No
Secondary	safety	Occurrence of side effects	From drug intake to the end of colonoscopy	Yes