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

NCT00611442 | Completed Results DMC

• 2 other identifiers: C.2007.188IND 78254
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Preparation for Colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Patient Satisfaction With the Prep Measured by 5 Point Likert Scale

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

• Procedure Time

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

• The Number of Polyps Detected on Examination

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

Study Arms (2)

1

ACTIVE COMPARATOR

split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment

Drug: lubiprostone

2

PLACEBO COMPARATOR

split-dose PEG solution without dietary restrictions plus placebo pretreatment

Drug: placebo

Interventions

lubiprostone DRUG

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

Also known as: amitiza

1

placebo DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Brooke Army Medical Center: lead
• Takeda: collaborator

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (5)

• 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. doi: 10.1111/j.1572-0241.2002.07129.x.

  PMID: 12492209 BACKGROUND

• Tan JJ, Tjandra JJ. Which is the optimal bowel preparation for colonoscopy - a meta-analysis. Colorectal Dis. 2006 May;8(4):247-58. doi: 10.1111/j.1463-1318.2006.00970.x.

  PMID: 16630226 BACKGROUND

• 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. doi: 10.1067/mge.2003.318.

  PMID: 12838218 BACKGROUND

• 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. doi: 10.1007/BF02258217.

  PMID: 9788383 BACKGROUND

• Lacy BE, Levy LC. Lubiprostone: a chloride channel activator. J Clin Gastroenterol. 2007 Apr;41(4):345-51. doi: 10.1097/01.mcg.0000225665.68920.df.

  PMID: 17413599 BACKGROUND

MeSH Terms

Interventions

Lubiprostone

Intervention Hierarchy (Ancestors)

Alprostadil; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Limitations and Caveats

This study may be limited by the recruitment of outpatients as the only study participants. The study results might have also been affected by limiting the indication for colonoscopy to colorectal cancer screening.

Results Point of Contact

• Title: Dr. Joel Stengel
• Organization: Carl R Darnall Army Medical Center

joel.stengel@us.army.mil

2545531804

Study Officials

• Joel Z Stengel, MD

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterology Fellow

Study Record Dates

• First Submitted: January 29, 2008
• First Posted: February 11, 2008
• Study Start: October 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: November 1, 2012
• Results First Posted: November 1, 2012

Record last verified: 2012-10

Locations

US (1)