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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

March 22, 2011
April 4, 2013
March 2011
June 2011   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01324284 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation for Colonoscopy
Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation to Enhance the Colonoscopy Preparation Quality in an Indian Tertiary Care Center.

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.

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)
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Colorectal Carcinoma
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
  • Experimental: Lubiprostone
    Lubiprostone with PEG solution versus Placebo with PEG solution
    Intervention: Drug: Lubiprostone
  • Placebo Comparator: lubiprostone versus placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
442
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01324284
AIG-GI2011-01
No
Rupa Banerjee, Asian Institute of Gastroenterology, India
Asian Institute of Gastroenterology, India
Not Provided
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
Asian Institute of Gastroenterology, India
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP