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

• ClinicalTrials.gov Identifier: NCT00611442
• Recruitment Status: Completed
• First Posted: February 11, 2008
• Results First Posted: November 1, 2012
• Last Update Posted: November 1, 2012
• Sponsor: Brooke Army Medical Center
• Collaborator: Takeda
• Information provided by (Responsible Party): Joel Z. Stengel, Brooke Army Medical Center

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Bowel Preparation for Colonoscopy	Drug: lubiprostone; Drug: placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 191 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• 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
• Study Start Date: October 2007
• Actual Primary Completion Date: January 2008
• Actual Study Completion Date: January 2008

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1; split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment	Drug: lubiprostone; lubiprostone 24mcg gelcap, 1 gelcap taken at noon the day prior to the colonoscopy; Other Name: amitiza
Placebo Comparator: 2; split-dose PEG solution without dietary restrictions plus placebo pretreatment	Drug: placebo; placebo gelcap, taken at noon the day prior to the colonoscopy

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Texas

Brooke Army Medical Center

Fort Sam Houston, Texas, United States, 78234

Sponsors and Collaborators

Brooke Army Medical Center

Takeda

Investigators

• Principal Investigator: Joel Z Stengel, MD; Brooke Army Medical Center

More Information

Publications:

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.

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

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.

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.

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

• Responsible Party: Joel Z. Stengel, Gastroenterology Fellow, Brooke Army Medical Center
• ClinicalTrials.gov Identifier: NCT00611442
• Other Study ID Numbers: C.2007.188; IND 78254
• First Posted: February 11, 2008
• Results First Posted: November 1, 2012
• Last Update Posted: November 1, 2012
• Last Verified: October 2012

Additional relevant MeSH terms:

Lubiprostone; Chloride Channel Agonists; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action