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Safety, Efficacy, and Tolerance of Pico-Salax for Colon Cleansing Prior to Colonoscopy in an Elderly Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00906217
Recruitment Status : Completed
First Posted : May 21, 2009
Last Update Posted : September 15, 2011
Sponsor:
Information provided by (Responsible Party):
Lawrence Hookey, Queen's University

Tracking Information
First Submitted Date May 19, 2009
First Posted Date May 21, 2009
Last Update Posted Date September 15, 2011
Study Start Date January 2009
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 20, 2009)
serum electrolyte changes pre and post preparation [ Time Frame: 2 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00906217 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Safety, Efficacy, and Tolerance of Pico-Salax for Colon Cleansing Prior to Colonoscopy in an Elderly Population
Official Title Safety, Efficacy, and Tolerance of Pico-Salax for Colon Cleansing Prior to Colonoscopy in an Elderly Population
Brief Summary This study aims to further define the appropriate population for Pico-Salax, a purgative used prior to colonoscopy. Patients over the age of 70 years with normal renal function scheduled for colonoscopy will receive Pico-Salax and have pre and post preparation bloodwork and electrocardiograms (ECGs).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients older than 70 scheduled for colonoscopy
Condition Colon Cleansing
Intervention Not Provided
Study Groups/Cohorts elderly patients
patients older than 70 years with normal renal function
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: May 20, 2009)
50
Original Estimated Enrollment Same as current
Actual Study Completion Date September 2011
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • >70 years

Exclusion Criteria:

  • renal dysfunction
  • congestive heart failure
  • ileus
Sex/Gender
Sexes Eligible for Study: All
Ages 70 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries Canada
 
Administrative Information
NCT Number NCT00906217
Other Study ID Numbers Hookey Picosalax Elderly Trial
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Lawrence Hookey, Queen's University
Study Sponsor Queen's University
Collaborators Not Provided
Investigators
Principal Investigator: Lawrence Hookey, MD Queen's University
PRS Account Queen's University
Verification Date September 2011