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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rupa Banerjee, Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier:
NCT01324284
First received: March 22, 2011
Last updated: April 4, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Colorectal Carcinoma
Drug: Lubiprostone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
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.

Resource links provided by NLM:


Further study details as provided by Asian Institute of Gastroenterology, India:

Primary Outcome Measures:
  • Quality of bowel preparation in Same day Low volume PEG with placebo versus same day low volume PEG with Lubiprostone [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    Quality of bowel preparation is based on Boston Bowel Preparation Score (BBPS)


Enrollment: 442
Study Start Date: March 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lubiprostone
Lubiprostone with PEG solution versus Placebo with PEG solution
Drug: Lubiprostone
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.
Other Name: Lubiprostone
Placebo Comparator: lubiprostone versus placebo

Detailed Description:

Objectives:

  1. 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
  2. Secondary:

    • Quality of bowel preparation without Dietary restriction (Modified bowel preparation regime without Fiber diet restrictions)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01324284

Sponsors and Collaborators
Asian Institute of Gastroenterology, India
Investigators
Study Director: Nageshwar D Reddy, MD. DM Asian Institute of Gastroenterolgy India
Principal Investigator: Rupa Banerjee, MD Asian Institute of Gastroenterology, India
Principal Investigator: Saravanan Arjunan, MD Asian Institute of Gastroenterology, India
Principal Investigator: Manu Tandan, MD DM AIG Hyderabad india
  More Information

No publications provided

Responsible Party: Rupa Banerjee, Consultant gastroenterologist, Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier: NCT01324284     History of Changes
Other Study ID Numbers: AIG-GI2011-01
Study First Received: March 22, 2011
Last Updated: April 4, 2013
Health Authority: India: Institutional Review Board

Keywords provided by Asian Institute of Gastroenterology, India:
Lubiprostone
Bowel preparation regime

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 23, 2014