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OpenTrials
Completed

NCT Number: NCT00611442

Split Dose Golytely With Amitiza Pretreatment Versus Split Dose Golytely Plus Placebo in Outpatient Colonoscopy

The primary outcomes of this procedure will be: 1. The cleanliness of the prep as measured by the Ottawa Scale (attachment a). Secondary outcomes will be: 1. Patient satisfaction with the prep measured by 5 point Likert scale (attachment b); 2. Procedure time; 3. The number and size of polyps detected on examination.

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Key information

Conditions

Bowel Preparation for Colonoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients referred to our clinic for Average or Increased Risk screening for Colorectal Cancer
  • Ages will be from 18 years of age and older

Exclusion criteria

  • Chronic kidney disease
  • Previous diagnosis of congestive heart failure
  • History of bowel obstruction
  • History of solid organ transplant
  • Pregnancy

Treatment and study plan

Lubiprostone

Drug

lubiprostone 24mcg gelcap, 1 gelcap taken at noon the day prior to the colonoscopy

Other names: amitiza

Placebo

Drug

placebo gelcap, taken at noon the day prior to the colonoscopy

Primary outcomes

  1. The Overall Cleanliness of the Prep as Measured by the Ottawa Scale

    Time frame: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)

    Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid

Secondary outcomes

  1. Patient Satisfaction With the Prep Measured by 5 Point Likert Scale

    Time frame: measured after completion of the bowel preparation and prior to the colonoscopy, completed during the course of the study (approximately 4 month period)

    The participants completed a survey prior to the colonoscopy that graded their overall satisfaction with the bowel preparation. The subjects rated the survey questions on a 5-point Likert scale where 1 = severely distressing, 2=distressing, 3=bothersome, 4=mild, and 5=none.

  2. Procedure Time

    Time frame: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)

    Procedure time refers to the total length of time required to complete the colonoscopy

  3. The Number of Polyps Detected on Examination

    Time frame: measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)

    The number of colon polyps detected during the colonoscopy.

Sponsors and collaborators

Lead sponsor

Brooke Army Medical Center

Fed

Collaborators

  • Takeda

Registry information

Official study title

Single Dose Lubiprostone Along With Split-dose PEG Solution Without Dietary Restrictions for Bowel Cleansing Prior to Colonoscopy, a Randomized, Double-blind, Placebo Controlled Trial

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 11, 2008
Registry last updated
Nov 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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