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

Bowel Preparation for Colonoscopy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00611442
• Other study ID #: C.2007.188
• Secondary ID: IND 78254
• Status: Completed
• Phase: N/A
• First received: January 29, 2008
• Last updated: October 3, 2012
• Start date: October 2007
• Est. completion date: January 2008

Study information

• Verified date: October 2012
• Source: Brooke Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bowel Preparation for Colonoscopy

Intervention

Drug:
• lubiprostone
lubiprostone 24mcg gelcap, 1 gelcap taken at noon the day prior to the colonoscopy
• placebo
placebo gelcap, taken at noon the day prior to the colonoscopy

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	Fort Sam Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Brooke Army Medical Center	Takeda

Country where clinical trial is conducted

United States, 

References & Publications (5)

Church JM. Effectiveness of polyethylene glycol antegrade gut lavage bowel preparation for colonoscopy--timing is the key! Dis Colon Rectum. 1998 Oct;41(10):1223-5. — View Citation

El Sayed AM, Kanafani ZA, Mourad FH, Soweid AM, Barada KA, Adorian CS, Nasreddine WA, Sharara AI. A randomized single-blind trial of whole versus split-dose polyethylene glycol-electrolyte solution for colonoscopy preparation. Gastrointest Endosc. 2003 Jul;58(1):36-40. — View Citation

Harewood GC, Wiersema MJ, Melton LJ 3rd. A prospective, controlled assessment of factors influencing acceptance of screening colonoscopy. Am J Gastroenterol. 2002 Dec;97(12):3186-94. — View Citation

Lacy BE, Levy LC. Lubiprostone: a chloride channel activator. J Clin Gastroenterol. 2007 Apr;41(4):345-51. Review. — View Citation

Tan JJ, Tjandra JJ. Which is the optimal bowel preparation for colonoscopy - a meta-analysis. Colorectal Dis. 2006 May;8(4):247-58. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Overall Cleanliness of the Prep as Measured by the Ottawa Scale	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	measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)	No
Secondary	Patient Satisfaction With the Prep Measured by 5 Point Likert Scale	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.	measured after completion of the bowel preparation and prior to the colonoscopy, completed during the course of the study (approximately 4 month period)	No
Secondary	Procedure Time	Procedure time refers to the total length of time required to complete the colonoscopy	measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)	No
Secondary	The Number of Polyps Detected on Examination	The number of colon polyps detected during the colonoscopy.	measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)	No