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Evaluation of an Oral Sodium Sulfate Solution for Patients With Prior Difficult or Incomplete Cleansing (OSS)

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ClinicalTrials.gov Identifier: NCT06051955
Recruitment Status : Recruiting
First Posted : September 25, 2023
Last Update Posted : April 3, 2024
Sponsor:
Collaborator:
Pendopharm
Information provided by (Responsible Party):
Lawrence Charles Hookey, Queen's University

Study Description
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Brief Summary:
This case series aims to evaluate the effectiveness and tolerability of Oral Sulfate Solution (OSS) in patients who had previously experienced poor colonoscopy preparation.

Condition or disease Intervention/treatment Phase
Colonoscopy Bowel Preparation Other: oral sodium sulfate Not Applicable

Detailed Description:

This study aims to evaluate the effectiveness of Oral Sodium Sulfate (OSS) in patients who have had poor colon preparation in the past. The study includes patients who had issues during their previous colonoscopy, such as needing extensive washing, inadequate preparation, a recommendation for shorter surveillance intervals, or adequate preparation for larger polyps but not smaller lesions.

Poor colon cleansing during a colonoscopy can lead to more prolonged procedures, lower polyp detection rates, and the need for repeat procedures with shorter surveillance intervals. OSS is a low-volume osmotic agent that causes diarrhea and colon cleansing by drawing water into the intestine. Health Canada and the FDA have approved it, and it is given in two 177ml bottles in a split dose. OSS is known for its good effect, ease of use, and tolerability, and it may be a better option than traditional cleansing agents.

All participants will receive OSS and instructions for use before their next surveillance colonoscopy. The study will use questionnaires and patient diaries to assess the effectiveness of OSS and patient compliance and tolerability.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This study will enroll participants who have experienced difficult or incomplete bowel cleansing in the past. All participants will use oral sodium sulfate as their cleansing agent.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of an Oral Sodium Sulfate Solution for Patients With Prior Difficult or Incomplete Cleansing, a Progressive Case Series.
Actual Study Start Date : October 11, 2023
Estimated Primary Completion Date : May 30, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
oral sodium sulfate
OSS is a colon cleansing agent administered in a split dose fashion, inducing diarrhea by drawing water into the intestine.
 Other: oral sodium sulfate
All participants enrolled in this study will use Oral Sodium Sulfate as their bowel cleansing agent.


Outcome Measures
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Primary Outcome Measures :
  1. Effectiveness [ Time Frame: 1-2 days ]
    The primary outcome is proportion of patients with an adequate preparation (Boston preparation scale 6 or greater, with no section less than 2).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients Age 18 to 80 inclusive
  2. Able to read and understand the English language

  3. History of poor bowel prep defined as:

    • Required extensive washing, as noted in the narrative of the endoscopist report.
    • Inadequate preparation
    • Endoscopist recommended shorter interval surveillance due to poor prep
    • adequate for polyps >5mm but not smaller lesions

Exclusion Criteria:

  1. Patients who have inflammatory bowel disease
  2. Patients with ileus or bowel obstruction
  3. Patients with history of colorectal resection
  4. Patients receiving combined upper and lower endoscopies
  5. Patients with ascites
  6. Patients with previously documented severe renal impairment
  7. Unable to provide consent
  8. Pregnant or lactating female (females of child-bearing potential will undergo urine pregnancy testing)
  9. Patients who have had a recent myocardial infarction(<6months)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06051955


Contacts
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Contact: Jackie McKay 613-544-3400 ext 2440 jackie.mckay@kingstonhsc.ca
Contact: Rana Mohanna 613-544-3400 ext 2285 rana.mohanna@kingstonhsc.ca

Locations
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Canada, Ontario
Hotel Dieu Hospital Recruiting
Kingston, Ontario, Canada, K7L 5G2
Contact: Jackie McKay    613 544 3400 ext 2440    jackie.mckay@kingstonhsc.ca   
Principal Investigator: Lawrence Hookey         
Hotel Dieu Hospital Recruiting
Kingston, Ontario, Canada, K7L5G2
Contact: Lawrence Hookey       Lawrence.Hookey@kingstonhsc.ca   
Sponsors and Collaborators
Lawrence Charles Hookey
Pendopharm
Investigators
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Principal Investigator: Lawrence Hookey Queen's University
More Information
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Publications:

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Responsible Party: Lawrence Charles Hookey, Professor, Queen's University
ClinicalTrials.gov Identifier: NCT06051955    
Other Study ID Numbers: 6039506
First Posted: September 25, 2023    Key Record Dates
Last Update Posted: April 3, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lawrence Charles Hookey, Queen's University:
Oral sodium sulfate
Additional relevant MeSH terms:
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Sodium sulfate
Cathartics
Gastrointestinal Agents