Bowel Preparation for ColonoscopyPhase 3NCT05465889
Efficacy and Safety of Oral Sulfate Solution on Bowel Preparation for Colonoscopy
A Phase 3 study testing Oral sulfate solution (OSS) and Polyethylene Glycol Electrolyte in people with Bowel Preparation for Colonoscopy, run by Changhai Hospital at 1 site in China.
Trial summary
To evaluate whether oral sulfate solution used for colon cleaning in adults prior to colonoscopy was not inferior to 3-liter polyethylene glycol in the proportion of subjects with BBPS score (total colon) ≥6 after colonoscopy Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation for Colonoscopy
- What is being tested?
- Oral sulfate solution (OSS) and Polyethylene Glycol Electrolyte
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2019to 15 Mar 2020
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntarily participate and sign informed consent;
- Scheduling screening, surveillance, and diagnostic colonoscopy;
- Necessary body fluid and blood electrolyte balance (the test values of potassium, sodium, chlorine, calcium and magnesium in blood biochemistry during screening period should not exceed 10% of the normal range).
Who cannot join
- Subjects who used drugs that affect gastrointestinal dynamics, affect kidney function, or increase the risk of fluid retention or electrolyte disorders within 7 days before the start of the trial;
- Subjects with serious cardiac and cerebrovascular diseases, bronchial and lung diseases, suffering from metabolic disease or endocrine disease, abnormal blood clotting mechanism, malignant tumor, electrolyte abnormalities, epilepsy, Renal or liver dysfunction;
- Subjects with confirmed or suspected gastrointestinal obstruction, gastric retention, gastroparesis, gastric emptying disorder or acute gastrointestinal bleeding;
- Subjects with acute severe colitis (such as active severe inflammatory bowel disease, acute bacterial dysentery, diverticulitis, etc.);
- Subjects with a history of major gastrointestinal surgery (e.g. gastric bypass, gastric septal surgery, colostomy, colectomy, etc.);
- Subjects with constipation or suspected severe gastric motility disorder;
Show all 9Show fewer
- Women with positive pregnancy tests or pregnancy plans, and women in lactation;
- Subjects who have participated in any other clinical trials within the last 3 months;
- Subjects with any other conditions that the investigator considered inappropriate for inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy and Safety of Oral Sulfate Solution and 3-liter Polyethylene Glycol on Bowel Preparation Before Colonoscopy: a Multicenter Randomized Controlled Phase III Trial
To evaluate whether oral sulfate solution used for colon cleaning in adults prior to colonoscopy was not inferior to 3-liter polyethylene glycol in the proportion of subjects with BBPS score (total colon) ≥6 after colonoscopy
Read the detailed description
Polyethylene glycol (PEG) is the most widely used laxative at present, but volume of oral PEG liquid is large and the taste of PEG is not good, so some patients could not take enough laxative to complete bowel preparation. Oral sulfate solution containing sodium sulfate, magnesium sulfate, and potassium sulfate as active ingredients was developed as osmotic laxative for bowel cleansing preparation. The OSS works on the principle that sulfate is a poorly absorbed anion. Compared to traditional magnesium sulfate solution, OSS not only tastes better, but also reduces the occurrence of electrolyte disturbances.
- Conditions
- Bowel Preparation for Colonoscopy
- Being tested
- Oral sulfate solution (OSS), Polyethylene Glycol Electrolyte
- Keywords
- colonoscopy, Bowel preparation, Sodium Potassium and Magnesium Sulfate, polyethylene glycol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral sulfate solution (OSS)Drug
OSS contained 17.5 g sodium sulfate, 3.13 g potassium sulfate, 1.6 g magnesium sulfate, and flavoring agents in an aqueous liquid form supplied in a 177 mL bottle. Take 177ml sodium, potassium and magnesium sulfates oral solution (diluted to 480ml) within 30 minutes 14-16 hours before colonoscopy, followed by two doses of 480ml warm water within 1 hour; Repeat the procedure 3-4 hours before colonoscopy.
Polyethylene Glycol ElectrolyteDrug
Take 1000 ml polyethylene glycol electrolyte solution within 1 hour at 8 p.m. the day before colonoscopy; take 2000 ml polyethylene glycol electrolyte solution within 2 hour 4-6 hours before colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| OSS group | Experimental | Bowel preparation for colonoscopy was performed using oral sulfate solution as laxative Receives: Drug: Oral sulfate solution (OSS) |
| Polyethylene glycol group | Active comparator | Bowel preparation for colonoscopy was performed using polyethylene glycol as laxative Receives: Drug: Polyethylene Glycol Electrolyte |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel preparation adequate rate
Proportion of subjects with total Boston bowel preparation scale (BBPS) score (total colon) ≥6.
Measured: 30 minutes
Secondary outcomes (4)
Boston bowel preparation scale (BBPS) score
The BBPS scoring rules: 0, unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared; 1, portion of mucosa of the colon segment seen, but other areas of the colon segment are not well seen because of staining, residual stool, and/or opaque liquid; 2, minor amount of residual staining, small fragments of stool, and/or opaque liquid, but mucosa of colon segment is seen well; 3, entire mucosa of colon segment seen well, with no residual staining, small fragments of stool, or opaque liquid. the higher the score, the better the quality of bowel preparation.
3 intestinal segments were scored separately: the right side of the colon (including the cecum and ascending colon), the transverse section of the colon (including the hepatic and splenic flexures), and the left side of the colon (including the descending colon, sigmoid colon, and rectum).
Total BBPS score (0-9, the higher the score, the better the quality of bowel preparation).
Measured: 30 minutes
Acceptability of laxatives by questionnaire survey
The proportion of people who accept the laxative. Level I: the laxative has good taste and is easy to take; the intestinal clearing fluid is drunk smoothly; the intestinal preparation process is easily tolerated; Level II: The laxative has a general taste and is easy to take. The intestinal fluid is basically drunk on time, and the intestinal preparation process is barely tolerated; Level III: unacceptable laxative taste, difficult to take medicine, unable to drink the clear bowel fluid on time, intolerable bowel preparation process, refuse similar experience in the future. Under level I and Level II, the laxative was considered to be acceptable. Under level III, the laxative was considered not to be acceptable.
Measured: 12 hours
Colonoscopy completion rate
Proportion of subjects receiving complete colonoscopy
Measured: 30 minutes
Incidence of laxative-related adverse events assessed by clinical examinations
Physical examination (skin, mucous membranes, lymph nodes, head, neck, chest, abdomen, limbs), vital signs (temperature, respirations, heart rate, blood pressure), blood routine, urine routine, blood biochemistry (DBIL, TBIL, UREA, Cr, AST, ALT, TP, ALB, GLU, TG, TC, CK, ALP, K, Na, Cl, Ca, Mg, UA), coagulation function, and 12-lead electrocardiogram were performed within 7 days before taking laxatives. The clinical examinations were repeated on the same day after the colonoscopy. All abnormal changes in clinical examination results will be assessed by clinical specialists to determine if they are related to laxative intake. Incidence was calculated as the number of subjects with laxative-related adverse events divided by the total number of subjects.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start15 May 2019
- Primary completion9 Jan 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bowel Preparation for ColonoscopyStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, China-japan Friendship Hospital, Jilin University, Beijing Hospital, The First Affiliated Hospital of Nanchang University, Zhongshan Hospital Xiamen University, Henan Provincial People's Hospital, Hebei Provincial People's Hospital, Shandong University Qilu Hospital
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- li.zhaoshen@hotmail.com li.zhaoshen@hotmail.com, M.D., Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465889
- Sponsor's protocol ID
- SPMS oral solution
- Status last verified
- Jul 2022
- First submitted
- 21 Feb 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kluge MA, Williams JL, Wu CK, Jacobson BC, Schroy PC 3rd, Lieberman DA, Calderwood AH. Inadequate Boston Bowel Preparation Scale scores predict the risk of missed neoplasia on the next colonoscopy. Gastrointest Endosc. 2018 Mar;87(3):744-751. doi: 10.1016/j.gie.2017.06.012. Epub 2017 Jun 23.
PubMed 28648575Johnson 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 25239068Pan P, Zhao S, Wang S, Song Y, Gu L, Chen Y, Zhao J, Lu L, Li X, Xu H, Liu G, Li Y, Xu L, Wang J, Li Z, Bai Y. Comparison of the efficacy and safety of an oral sulfate solution and 3-L polyethylene glycol on bowel preparation before colonoscopy: a phase III multicenter randomized controlled trial. Gastrointest Endosc. 2023 Dec;98(6):977-986.e14. doi: 10.1016/j.gie.2023.06.070. Epub 2023 Jul 6.
PubMed 37422241
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Safety of Oral Sulfate Solution and 3-liter Polyethylene Glycol on Bowel Preparation Before Colonoscopy: a Multicenter Randomized Controlled Phase III Trial
- ClinicalTrials.gov ID
- NCT05465889
- Acronym / sponsor ID
- SPMS oral solution
- Conditions
- Bowel Preparation for Colonoscopy
- Keywords
- colonoscopy, Bowel preparation, Sodium Potassium and Magnesium Sulfate, polyethylene glycol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, China-japan Friendship Hospital, Jilin University, Beijing Hospital, The First Affiliated Hospital of Nanchang University, Zhongshan Hospital Xiamen University, Henan Provincial People's Hospital, Hebei Provincial People's Hospital, Shandong University Qilu Hospital
- Study start
- 15 May 2019 (actual)
- Primary completion
- 9 Jan 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 20 Jul 2022 (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.
To evaluate whether oral sulfate solution used for colon cleaning in adults prior to colonoscopy was not inferior to 3-liter polyethylene glycol in the proportion of subjects with BBPS score (total colon) ≥6 after colonoscopy
Detailed description
Polyethylene glycol (PEG) is the most widely used laxative at present, but volume of oral PEG liquid is large and the taste of PEG is not good, so some patients could not take enough laxative to complete bowel preparation. Oral sulfate solution containing sodium sulfate, magnesium sulfate, and potassium sulfate as active ingredients was developed as osmotic laxative for bowel cleansing preparation. The OSS works on the principle that sulfate is a poorly absorbed anion. Compared to traditional magnesium sulfate solution, OSS not only tastes better, but also reduces the occurrence of electrolyte disturbances.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSS group | Experimental | Drug: Oral sulfate solution (OSS)Bowel preparation for colonoscopy was performed using oral sulfate solution as laxative |
| Polyethylene glycol group | Active comparator | Drug: Polyethylene Glycol ElectrolyteBowel preparation for colonoscopy was performed using polyethylene glycol as laxative |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Voluntarily participate and sign informed consent;
- Scheduling screening, surveillance, and diagnostic colonoscopy;
- Necessary body fluid and blood electrolyte balance (the test values of potassium, sodium, chlorine, calcium and magnesium in blood biochemistry during screening period should not exceed 10% of the normal range).
Key exclusion criteria (9 listed)
- Subjects who used drugs that affect gastrointestinal dynamics, affect kidney function, or increase the risk of fluid retention or electrolyte disorders within 7 days before the start of the trial;
- Subjects with serious cardiac and cerebrovascular diseases, bronchial and lung diseases, suffering from metabolic disease or endocrine disease, abnormal blood clotting mechanism, malignant tumor, electrolyte abnormalities, epilepsy, Renal or liver dysfunction;
- Subjects with confirmed or suspected gastrointestinal obstruction, gastric retention, gastroparesis, gastric emptying disorder or acute gastrointestinal bleeding;
- Subjects with acute severe colitis (such as active severe inflammatory bowel disease, acute bacterial dysentery, diverticulitis, etc.);
- Subjects with a history of major gastrointestinal surgery (e.g. gastric bypass, gastric septal surgery, colostomy, colectomy, etc.);
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 sulfate solution (OSS)OSS contained 17.5 g sodium sulfate, 3.13 g potassium sulfate, 1.6 g magnesium sulfate, and flavoring agents in an aqueous liquid form supplied in a 177 mL bottle. Take 177ml sodium, potassium and magnesium sulfates oral solution (diluted to 480ml) within 30 minutes 14-16 hours before colonoscopy, followed by two doses of 480ml warm water within 1 hour; Repeat the procedure 3-4 hours before colonoscopy. | Drug | OSS group |
| Polyethylene Glycol ElectrolyteTake 1000 ml polyethylene glycol electrolyte solution within 1 hour at 8 p.m. the day before colonoscopy; take 2000 ml polyethylene glycol electrolyte solution within 2 hour 4-6 hours before colonoscopy. | Drug | Polyethylene glycol group |
Primary outcome
Bowel preparation adequate rate
Time frame: 30 minutes
Proportion of subjects with total Boston bowel preparation scale (BBPS) score (total colon) ≥6.
4 secondary outcomes
Boston bowel preparation scale (BBPS) score
Time frame: 30 minutes
Acceptability of laxatives by questionnaire survey
Time frame: 12 hours
Colonoscopy completion rate
Time frame: 30 minutes
Incidence of laxative-related adverse events assessed by clinical examinations
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Background: PubMed 28648575Kluge MA, Williams JL, Wu CK, Jacobson BC, Schroy PC 3rd, Lieberman DA, Calderwood AH. Inadequate Boston Bowel Preparation Scale scores predict the risk of missed neoplasia on the next colonoscopy. Gastrointest Endosc. 2018 Mar;87(3):744-751. doi: 10.1016/j.gie.2017.06.012. Epub 2017 Jun 23.
- 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.
- Derived from this study: PubMed 37422241Pan P, Zhao S, Wang S, Song Y, Gu L, Chen Y, Zhao J, Lu L, Li X, Xu H, Liu G, Li Y, Xu L, Wang J, Li Z, Bai Y. Comparison of the efficacy and safety of an oral sulfate solution and 3-L polyethylene glycol on bowel preparation before colonoscopy: a phase III multicenter randomized controlled trial. Gastrointest Endosc. 2023 Dec;98(6):977-986.e14. doi: 10.1016/j.gie.2023.06.070. Epub 2023 Jul 6.
- Individual participant dataSharing planned: No
Related trials for Bowel Preparation for Colonoscopy
Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
Not yet recruiting
Enhanced Ward Rounds for Bowel Preparation Quality in Hospitalized Patients Undergoing Colonoscopy
Colonoscopy, Bowel Preparation
RecruitingPhase 3
A Study to Investigate Bowel Cleansing With PLENVU® Compared to Sodium Picosulfate in Participants Aged 1 to < 18 Years of Age in Preparation for Colonoscopy
Bowel Cleansing Prior to Clinical Procedures
Recruiting
Comparison of Electrolyte Beverages and Water as Solvents for Bowel Preparation
Bowel Preparation Before Colonoscopy
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.
li.zhaoshen@hotmail.com li.zhaoshen@hotmail.com, M.D. principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral sulfate solution (OSS) and Polyethylene Glycol Electrolyte in people with Bowel Preparation for Colonoscopy, run by Changhai Hospital at 1 site in China.
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 3 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: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel preparation adequate rate (time frame: 30 minutes). 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 NCT05465889, which also lists 3 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 26 Jul 2022.