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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
Asian Institute of Gastroenterology, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Carcinoma focused on measuring Lubiprostone, Bowel preparation regime

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. All adult patient referred for colonoscopy to AIG
  2. Age 18 - 75 years old

Exclusion Criteria:

  1. Acute GI bleeding.
  2. Patient of bowel preparation regime other than excepted for the study.
  3. Renal insufficiency.
  4. Dementia.
  5. Symptomatic heart failure.
  6. Recent Myocardial Infarction.
  7. Patients with ileus.
  8. Suspected bowel obstruction.
  9. Prior alimentary tract surgery.
  10. Significant gastroparesis.
  11. Gastric outlet obstruction.
  12. Toxic colitis or megacolon.
  13. 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

    First Posted
    March 22, 2011
    Last Updated
    April 4, 2013
    Sponsor
    Asian Institute of Gastroenterology, India
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    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

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    Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation for Colonoscopy

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