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

NCT ID: NCT00611442

Last Updated: 2012-11-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

191 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bowel Preparation for Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

lubiprostone

Intervention Type DRUG

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

2

split-dose PEG solution without dietary restrictions plus placebo pretreatment

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Interventions

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lubiprostone

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

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Other Intervention Names

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amitiza

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Takeda

INDUSTRY

Sponsor Role collaborator

Brooke Army Medical Center

FED

Sponsor Role lead

Responsible Party

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Joel Z. Stengel

Gastroenterology Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joel Z Stengel, MD

Role: PRINCIPAL_INVESTIGATOR

Brooke Army Medical Center

Locations

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Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 12492209 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16630226 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12838218 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9788383 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17413599 (View on PubMed)

Other Identifiers

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IND 78254

Identifier Type: -

Identifier Source: secondary_id

C.2007.188

Identifier Type: -

Identifier Source: org_study_id