Efficacy of Lubiprostone in Combination With Standard PEG Preparation

NCT00689026 | Terminated Results

• 1 other identifier: MCG 08-02-186
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A large population-based study has shown diabetes to be an independent risk factor for colon cancer compared to the general population. Thus, the completion of an adequately prepped colonoscopy is requisite in providing diabetics with adequate colon cancer screening. Recent data has shown that diabetic patients have poorer response to bowel cleansing compared to non-diabetics (with a standard PEG prep, only 62% of diabetic patients had their colonoscopy preps rated as good or better vs. 97% of normal patients, p\<0.001). This may be due to the fact that a majority of diabetic patients report constipation as a common gastrointestinal complaint. We postulate that lubiprostone (Amitiza), in combination with PEG, will have additional efficacy over standard PEG preparation, and provide optimal safe and effective colonic cleansing for diabetics.

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Keywords

Colonoscopy; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Cleansing; Preparation; PEG; Quality

Outcome Measures

Primary Outcomes (1)

• The Percentage of Patients That Received a Quality of Colonoscopy Preparation Rating of <=2 on a 5 Point Likert Scale.

  The quality of colonoscopy preparations as rated by blinded colonoscopists on a 5-point Likert Scale where 1=excellent, 2=good, 3=fair, 4=poor, 5=inadequate. It was expected that at least 100 patients would complete the trial.

  The outcome was measured at the completion of the colonscopy procedure. Average time to completion two hours

Study Arms (2)

Experimental

EXPERIMENTAL

The lubiprostone group will receive an additional two 24 mcg lubiprostone capsules, which will be taken orally the morning and evening of the day of the 4L PEG prep (before and after the 4L PEG prep).

Drug: Lubiprostone; Other: Polyethylene glycol with electrolytes

Control

ACTIVE COMPARATOR

All patients in the study will receive a standard oral dosing of 4L Polyethylene glycol with electrolytes colonoscopy preparation the day prior to their scheduled colonoscopy.

Other: Polyethylene glycol with electrolytes

Interventions

Lubiprostone DRUG

Two 24 mcg lubiprostone capsules, which will be taken orally the morning and evening of the day of the 4L PEG prep (before and after the 4L PEG prep).

Also known as: Amitiza

Experimental

Polyethylene glycol with electrolytes OTHER

Standard oral dosing of 4L Polyethylene glycol colonoscopy preparation the day prior to their scheduled colonoscopy.

Also known as: PEG, Nulytely

Control; Experimental

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with known diabetes (type I or II) undergoing elective colonoscopy at the Medical College of Georgia.
• Patients aged 50 years and older.
• Women must be post-menopausal or surgically sterile.
• Patients able to give a valid, informed consent.

You may not qualify if:

• Patients with impaired glucose tolerance.
• Patients with suspected acute or chronic pseudo-obstruction.
• Patients with active gastrointestinal bleeding.
• Patients with known inflammatory bowel disease.
• Patients with chronic diarrhea.
• Patients with prior colonic resection.
• Patients with active diverticulitis.
• Patients with a known colonic mass.
• Patients with clinical evidence of decompensated liver disease.
• Patients with clinical evidence of decompensated renal disease or patients on dialysis.
• Patients currently or previously taking lubiprostone.
• Patients with an allergy to lubiprostone.

Sponsors & Collaborators

• Augusta University: lead
• Takeda Pharmaceuticals North America, Inc.: collaborator

Study Sites (1)

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

Related Publications (1)

• Grigg E, Schubert MC, Hall J, Rahhal F, Raina D, Sridhar S, Chamberlain SM. Lubiprostone used with polyethylene glycol in diabetic patients enhances colonoscopy preparation quality. World J Gastrointest Endosc. 2010 Jul 16;2(7):263-7. doi: 10.4253/wjge.v2.i7.263.

  PMID: 21160617 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Interventions

Lubiprostone; Polyethylene Glycols; Electrolytes; polyethylene glycol 3350

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Alprostadil; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Inorganic Chemicals

Results Point of Contact

• Title: Dr. Sherman M. Chamberlain, Professor of Medicine
• Organization: Georgia Regent University

schamberlain@gru.edu

706-721-2238

Study Officials

• Sherman M Chamberlain, MD

  Augusta University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, DOM - Gastroenterology

Study Record Dates

• First Submitted: May 29, 2008
• First Posted: June 3, 2008
• Study Start: May 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: October 20, 2014
• Results First Posted: October 20, 2014

Record last verified: 2014-10

Locations

US (1)