Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation for Colonoscopy (Lubiprostone)
Primary Purpose
Colorectal Carcinoma
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Lubiprostone
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Carcinoma focused on measuring Lubiprostone, Bowel preparation regime
Eligibility Criteria
Inclusion Criteria:
- All adult patient referred for colonoscopy to AIG
- Age 18 - 75 years old
Exclusion Criteria:
- Acute GI bleeding.
- Patient of bowel preparation regime other than excepted for the study.
- Renal insufficiency.
- Dementia.
- Symptomatic heart failure.
- Recent Myocardial Infarction.
- Patients with ileus.
- Suspected bowel obstruction.
- Prior alimentary tract surgery.
- Significant gastroparesis.
- Gastric outlet obstruction.
- Toxic colitis or megacolon.
- Pregnant or lactating patients.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lubiprostone
lubiprostone versus placebo
Arm Description
Lubiprostone with PEG solution versus Placebo with PEG solution
Outcomes
Primary Outcome Measures
Quality of bowel preparation in Same day Low volume PEG with placebo versus same day low volume PEG with Lubiprostone
Quality of bowel preparation is based on Boston Bowel Preparation Score (BBPS)
Secondary Outcome Measures
Full Information
NCT ID
NCT01324284
First Posted
March 22, 2011
Last Updated
April 4, 2013
Sponsor
Asian Institute of Gastroenterology, India
1. Study Identification
Unique Protocol Identification Number
NCT01324284
Brief Title
Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation for Colonoscopy
Acronym
Lubiprostone
Official Title
Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation to Enhance the Colonoscopy Preparation Quality in an Indian Tertiary Care Center.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asian Institute of Gastroenterology, India
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Lubiprostone as an adjunct to the standard bowel preparation regime the quality of bowel preparation can be improved for a good colonoscopic examination without missing lesions and complications.
Detailed Description
Objectives:
Primary:
Same day Low volume PEG with placebo (Arm 1) versus same day low volume PEG with Lubiprostone (Arm 2)
Waiting time for colonoscopic procedure and quality of bowel preparation
Secondary:
Quality of bowel preparation without Dietary restriction (Modified bowel preparation regime without Fiber diet restrictions)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Carcinoma
Keywords
Lubiprostone, Bowel preparation regime
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
442 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lubiprostone
Arm Type
Experimental
Arm Description
Lubiprostone with PEG solution versus Placebo with PEG solution
Arm Title
lubiprostone versus placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lubiprostone
Intervention Description
Lubiprostone is a chloride channel activator approved by the Food and Drug Administration for the treatment of chronic constipation. A randomized, double-blind, parallel-group, placebo-controlled study evaluating the effect of lubiprostone on gastric function showed slowed gastric emptying and increased small bowel and colonic transit time. Peak plasma concentration was shown to be around 1.14 hours, with a majority of the drug excreted in the urine within 48 hours.
Primary Outcome Measure Information:
Title
Quality of bowel preparation in Same day Low volume PEG with placebo versus same day low volume PEG with Lubiprostone
Description
Quality of bowel preparation is based on Boston Bowel Preparation Score (BBPS)
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All adult patient referred for colonoscopy to AIG
Age 18 - 75 years old
Exclusion Criteria:
Acute GI bleeding.
Patient of bowel preparation regime other than excepted for the study.
Renal insufficiency.
Dementia.
Symptomatic heart failure.
Recent Myocardial Infarction.
Patients with ileus.
Suspected bowel obstruction.
Prior alimentary tract surgery.
Significant gastroparesis.
Gastric outlet obstruction.
Toxic colitis or megacolon.
Pregnant or lactating patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nageshwar D Reddy, MD. DM
Organizational Affiliation
Asian Institute of Gastroenterolgy India
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rupa Banerjee, MD
Organizational Affiliation
Asian Institute of Gastroenterology, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Saravanan Arjunan, MD
Organizational Affiliation
Asian Institute of Gastroenterology, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manu Tandan, MD DM
Organizational Affiliation
AIG Hyderabad india
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
27737636
Citation
Banerjee R, Chaudhari H, Shah N, Saravanan A, Tandan M, Reddy DN. Addition of Lubiprostone to polyethylene glycol(PEG) enhances the quality & efficacy of colonoscopy preparation: a randomized, double-blind, placebo controlled trial. BMC Gastroenterol. 2016 Oct 13;16(1):133. doi: 10.1186/s12876-016-0542-0.
Results Reference
derived
Learn more about this trial
Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation for Colonoscopy
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