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Efficacy of Lubiprostone in Combination With Standard PEG Preparation

This study has been completed.
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by:
Georgia Regents University
ClinicalTrials.gov Identifier:
NCT00689026
First received: May 29, 2008
Last updated: July 19, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
 Drug: Lubiprostone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Efficacy of Lubiprostone Used With Polyethylene Glycol to Enhance Colonoscopy Preparation Quality in Diabetic Patients: A Randomized Single-Blind Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Georgia Regents University:

Primary Outcome Measures:
  • The primary measured endpoint will be the quality of colonoscopy preparations as rated by blinded colonoscopists by a 5-point Likert Scale, and compared using the chi-square statistics. [ Time Frame: End of study ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: May 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
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).
Other Names:
  • Amitiza
  • Polyethylene glycol with electrolytes
  • PEG
  • Nulytely
Active Comparator: 2
All patients in the study will receive a standard oral 4L PEG colonoscopy preparation the day prior to their scheduled colonoscopy.
 Drug: Lubiprostone
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).
Other Names:
  • Amitiza
  • Polyethylene glycol with electrolytes
  • PEG
  • Nulytely

Detailed Description:

STUDY DESIGN

This is an investigator-initiated, single site (MCG only), single-blinded prospective study comparing the efficacy of Lubiprostone and 4L PEG (Nulytely) to 4L PEG alone on preparation quality in patients with known diabetes undergoing colonoscopy. Diabetic outpatients who require a colonoscopy will be randomized to one of the two groups of 60 (total of 120 patients):

Control Group: All patients in the study will receive a standard oral 4L PEG colonoscopy preparation the day prior to their scheduled colonoscopy.

Lubiprostone Group: 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 oral 4L PEG preparation).

Randomization Scheme: Subjects will be assigned to the Control Group or Lubiprostone Group, on an odd/even basis. After research informed consent has been obtained, subjects are given a study ID numbered 1 through 120. Subjects with an odd number will be assigned to Control Group, and subjects with an even number will be assigned to the Lubiprostone Group. Subjects then will be given a randomization package consisting of the preparation orders, supplies, instructions and the date of their procedure by the investigator obtaining informed consent. The colonoscopist will be blinded to which preparation was given.

Only diabetic patients who require an outpatient colonoscopy by a gastroenterologist at the outpatient MCG Clinic will be eligible for the study. Patients will be presented with a separate consent form for the colonoscopy procedure itself.

Standard of Care Procedures

  • Colonoscopy Procedure Consent
  • Colonoscopy

Study Procedures

  • Research Informed Consent
  • Disbursement of randomized preparation order and supplies, instructions, and date of procedure to subjects
  • Adverse Events

After the procedure, the physician who performed the colonoscopy will complete a form that rates the quality of the subject's colonoscopy preparation on a 1-5 rating scale.

The subject's study participation duration is two days (day of preparation and day of procedure). No follow-up visits will occur.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00689026

Locations
United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Georgia Regents University
Takeda Pharmaceuticals North America, Inc.
Investigators
Principal Investigator: Sherman M Chamberlain, MD Georgia Regents University
  More Information

No publications provided

Responsible Party: Sherman M. Chamberlain, M.D., FACP, AGAF, FACG, Assistant Professor of Medicine, Medical College of Georgia
ClinicalTrials.gov Identifier: NCT00689026     History of Changes
Other Study ID Numbers: MCG 08-02-186
Study First Received: May 29, 2008
Last Updated: July 19, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Georgia Regents University:
Colonoscopy
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Cleansing
 Preparation
PEG
Quality

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013