Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy of Lubiprostone in Combination With Standard PEG Preparation

This study has been terminated.
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Sherman Chamberlain, Georgia Regents University
ClinicalTrials.gov Identifier:
NCT00689026
First received: May 29, 2008
Last updated: October 17, 2014
Last verified: October 2014

May 29, 2008
October 17, 2014
May 2008
March 2010   (final data collection date for primary outcome measure)
The Percentage of Patients That Received a Quality of Colonoscopy Preparation Rating of <=2 on a 5 Point Likert Scale. [ Time Frame: The outcome was measured at the completion of the colonscopy procedure. Average time to completion two hours ] [ Designated as safety issue: No ]
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 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 ]
Complete list of historical versions of study NCT00689026 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy of Lubiprostone in Combination With Standard PEG Preparation
Efficacy of Lubiprostone Used With Polyethylene Glycol to Enhance Colonoscopy Preparation Quality in Diabetic Patients: A Randomized Single-Blind Controlled Trial

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.

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 4 Liters (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 Identification (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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
  • 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 Name: Amitiza
  • Other: Polyethylene glycol with electrolytes
    Standard oral dosing of 4L Polyethylene glycol colonoscopy preparation the day prior to their scheduled colonoscopy.
    Other Names:
    • PEG
    • Nulytely
  • 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).
    Interventions:
    • Drug: Lubiprostone
    • Other: Polyethylene glycol with electrolytes
  • Active Comparator: Control
    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.
    Intervention: Other: Polyethylene glycol with electrolytes
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00689026
MCG 08-02-186
No
Sherman Chamberlain, Georgia Regents University
Georgia Regents University
Takeda Pharmaceuticals North America, Inc.
Principal Investigator: Sherman M Chamberlain, MD Georgia Regents University
Georgia Regents University
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP