ColonoscopyOSSNCT06051955
Evaluation of an Oral Sodium Sulfate Solution for Patients With Prior Difficult or Incomplete Cleansing
A study testing oral sodium sulfate in people with Colonoscopy and Bowel Preparation, run by Lawrence Charles Hookey at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy, Bowel Preparation
- What is being tested?
- oral sodium sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesCanada
- Study dates
- 11 Oct 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients Age 18 to 80 inclusive
- Able to read and understand the English language
- 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
Who cannot join
- Patients who have inflammatory bowel disease
- Patients with ileus or bowel obstruction
- Patients with history of colorectal resection
- Patients receiving combined upper and lower endoscopies
- Patients with ascites
- Patients with previously documented severe renal impairment
Show all 9Show fewer
- Unable to provide consent
- Pregnant or lactating female (females of child-bearing potential will undergo urine pregnancy testing)
- Patients who have had a recent myocardial infarction(<6months)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Hotel Dieu Hospital
Kingston, Ontario, K7L 5G2
Jackie McKay, 613 544 3400 ext. 2440, jackie.mckay@kingstonhsc.ca
Lawrence Hookey
- Recruiting
Hotel Dieu Hospital
Kingston, Ontario, K7L5G2
Lawrence Hookey, Lawrence.Hookey@kingstonhsc.ca
About this study
Official title: Evaluation of an Oral Sodium Sulfate Solution for Patients With Prior Difficult or Incomplete Cleansing, a Progressive Case Series.
This case series aims to evaluate the effectiveness and tolerability of Oral Sulfate Solution (OSS) in patients who had previously experienced poor colonoscopy preparation.
Read the 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.
- Conditions
- Colonoscopy, Bowel Preparation
- Being tested
- oral sodium sulfate
- Keywords
- Oral sodium sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral sodium sulfateOther
All participants enrolled in this study will use Oral Sodium Sulfate as their bowel cleansing agent.
| Study group | Role | What they receive |
|---|---|---|
| oral sodium sulfate | Other | OSS is a colon cleansing agent administered in a split dose fashion, inducing diarrhea by drawing water into the intestine. Receives: Other: oral sodium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness
The primary outcome is proportion of patients with an adequate preparation (Boston preparation scale 6 or greater, with no section less than 2).
Measured: 1-2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start11 Oct 2023
- Primary completion30 May 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lawrence Charles Hookey
- Sponsor type
- University, hospital or other
- Collaborators
- Pendopharm
- Responsible party
- Sponsor-investigator, Lawrence Charles Hookey, Queen's University
- Investigators
- Lawrence Hookey, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051955
- Sponsor's protocol ID
- 6039506
- Acronym
- OSS
- Status last verified
- Apr 2024
- First submitted
- 18 Sep 2023
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Johnson DA, Barkun AN, Cohen LB, Dominitz JA, Kaltenbach T, Martel M, Robertson DJ, Boland CR, Giardello FM, Lieberman DA, Levin TR, Rex DK; US Multi-Society Task Force on Colorectal Cancer. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US multi-society task force on colorectal cancer. Gastroenterology. 2014 Oct;147(4):903-24. doi: 10.1053/j.gastro.2014.07.002. No abstract available.
PubMed 25239068Oldfield EC 4th, Johnson DA, Rex DK. Prescribing Colonoscopy Bowel Preparations: Tips for Maximizing Outcomes. Am J Gastroenterol. 2023 May 1;118(5):761-764. doi: 10.14309/ajg.0000000000002110. Epub 2022 Dec 26. No abstract available.
PubMed 36573902Wang CN, Yang R, Hookey L. Does It work in Clinical Practice? A Comparison of Colonoscopy Cleansing Effectiveness in Clinical Practice Versus Efficacy from Selected Prospective Trials. J Can Assoc Gastroenterol. 2020 Jun;3(3):111-119. doi: 10.1093/jcag/gwy070. Epub 2019 Feb 12.
PubMed 32395685Hookey LC, Vanner S. A review of current issues underlying colon cleansing before colonoscopy. Can J Gastroenterol. 2007 Feb;21(2):105-11. doi: 10.1155/2007/634125.
PubMed 17299615Anastassopoulos K, Farraye FA, Knight T, Colman S, Cleveland MV, Pelham RW. A Comparative Study of Treatment-Emergent Adverse Events Following Use of Common Bowel Preparations Among a Colonoscopy Screening Population: Results from a Post-Marketing Observational Study. Dig Dis Sci. 2016 Oct;61(10):2993-3006. doi: 10.1007/s10620-016-4214-2. Epub 2016 Jun 9.
PubMed 27278957Rex DK, DiPalma JA, McGowan J, Cleveland Mv. A comparison of oral sulfate solution with sodium picosulfate: magnesium citrate in split doses as bowel preparation for colonoscopy. Gastrointest Endosc. 2014 Dec;80(6):1113-23. doi: 10.1016/j.gie.2014.05.329. Epub 2014 Jul 12.
PubMed 25028274Yang HJ, Park SK, Kim JH, Im JP, Yeom DH, Seo GS, Park DI. Randomized trial comparing oral sulfate solution with 4-L polyethylene glycol administered in a split dose as preparation for colonoscopy. J Gastroenterol Hepatol. 2017 Jan;32(1):12-18. doi: 10.1111/jgh.13477.
PubMed 27349220
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Oral Sodium Sulfate Solution for Patients With Prior Difficult or Incomplete Cleansing, a Progressive Case Series.
- ClinicalTrials.gov ID
- NCT06051955
- Acronym / sponsor ID
- OSS / 6039506
- Conditions
- Colonoscopy, Bowel Preparation
- Keywords
- Oral sodium sulfate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Lawrence Charles HookeyUniversity, hospital or other
- Collaborators
- Pendopharm
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This case series aims to evaluate the effectiveness and tolerability of Oral Sulfate Solution (OSS) in patients who had previously experienced poor colonoscopy preparation.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| oral sodium sulfate | Other | Other: oral sodium sulfateOSS is a colon cleansing agent administered in a split dose fashion, inducing diarrhea by drawing water into the intestine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients Age 18 to 80 inclusive
- Able to read and understand the English language
- History of poor bowel prep defined as:
Key exclusion criteria (9 listed)
- Patients who have inflammatory bowel disease
- Patients with ileus or bowel obstruction
- Patients with history of colorectal resection
- Patients receiving combined upper and lower endoscopies
- Patients with ascites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral sodium sulfateAll participants enrolled in this study will use Oral Sodium Sulfate as their bowel cleansing agent. | Other | oral sodium sulfate |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Background: PubMed 25239068Johnson DA, Barkun AN, Cohen LB, Dominitz JA, Kaltenbach T, Martel M, Robertson DJ, Boland CR, Giardello FM, Lieberman DA, Levin TR, Rex DK; US Multi-Society Task Force on Colorectal Cancer. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US multi-society task force on colorectal cancer. Gastroenterology. 2014 Oct;147(4):903-24. doi: 10.1053/j.gastro.2014.07.002. No abstract available.
- Background: PubMed 36573902Oldfield EC 4th, Johnson DA, Rex DK. Prescribing Colonoscopy Bowel Preparations: Tips for Maximizing Outcomes. Am J Gastroenterol. 2023 May 1;118(5):761-764. doi: 10.14309/ajg.0000000000002110. Epub 2022 Dec 26. No abstract available.
- Background: PubMed 32395685Wang CN, Yang R, Hookey L. Does It work in Clinical Practice? A Comparison of Colonoscopy Cleansing Effectiveness in Clinical Practice Versus Efficacy from Selected Prospective Trials. J Can Assoc Gastroenterol. 2020 Jun;3(3):111-119. doi: 10.1093/jcag/gwy070. Epub 2019 Feb 12.
- Background: PubMed 17299615Hookey LC, Vanner S. A review of current issues underlying colon cleansing before colonoscopy. Can J Gastroenterol. 2007 Feb;21(2):105-11. doi: 10.1155/2007/634125.
- Background: PubMed 27278957Anastassopoulos K, Farraye FA, Knight T, Colman S, Cleveland MV, Pelham RW. A Comparative Study of Treatment-Emergent Adverse Events Following Use of Common Bowel Preparations Among a Colonoscopy Screening Population: Results from a Post-Marketing Observational Study. Dig Dis Sci. 2016 Oct;61(10):2993-3006. doi: 10.1007/s10620-016-4214-2. Epub 2016 Jun 9.
- Background: PubMed 25028274Rex DK, DiPalma JA, McGowan J, Cleveland Mv. A comparison of oral sulfate solution with sodium picosulfate: magnesium citrate in split doses as bowel preparation for colonoscopy. Gastrointest Endosc. 2014 Dec;80(6):1113-23. doi: 10.1016/j.gie.2014.05.329. Epub 2014 Jul 12.
- Background: PubMed 27349220Yang HJ, Park SK, Kim JH, Im JP, Yeom DH, Seo GS, Park DI. Randomized trial comparing oral sulfate solution with 4-L polyethylene glycol administered in a split dose as preparation for colonoscopy. J Gastroenterol Hepatol. 2017 Jan;32(1):12-18. doi: 10.1111/jgh.13477.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Hookey principal investigator
Queen's University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral sodium sulfate in people with Colonoscopy and Bowel Preparation, run by Lawrence Charles Hookey at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jackie McKay (613-544-3400 ext. 2440, jackie.mckay@kingstonhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness (time frame: 1-2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06051955, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.