Bowel PreparationPhase 4NCT04583111
The Effect of Antiemetics on Bowel Preparation Before Colonoscopy
A Phase 4 study testing Domperidone and sulpiride in people with Bowel Preparation, run by RenJi Hospital at 1 site in China.
Trial summary
Polyethylene glycol (PEG) is one of the most common laxatives used in colonoscopy. However, 5 - 15% of patients can not complete the preparation due to its poor taste and large volume. So this study is aimed to explore the effect of antiemetics on abdominal discomforts associated with PEG. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- Domperidone and sulpiride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 1 Mar 2022
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years patients scheduled for colonoscopy
Who cannot join
- intestinal obstruction or hemorrhage;
- allergy to domperidone, sulpiride or PEG;
- pregnancy or breastfeeding;
- previous use of prokinetics within 1 month.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shengliang Chen
Shanghai, 200001
Shengliang Chen, 02158752345, chenslmd@163.com
About this study
Polyethylene glycol (PEG) is one of the most common laxatives used in colonoscopy. However, 5 - 15% of patients can not complete the preparation due to its poor taste and large volume. So this study is aimed to explore the effect of antiemetics on abdominal discomforts associated with PEG.
- Conditions
- Bowel Preparation
- Being tested
- Domperidone, sulpiride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DomperidoneDrug
Domperidone and sulpiride are antiemetics that may be useful in preventing the PEG-related nausea and vomiting.
sulpirideDrug
Domperidone and sulpiride are antiemetics that may be useful in preventing the PEG-related nausea and vomiting.
| Study group | Role | What they receive |
|---|---|---|
| Domperidone group | Experimental | Patients in Domperidone group took 10mg of domperidone 30min before PEG. Receives: Drug: Domperidone |
| Sulpiride group | Experimental | Patients in Sulpiride group took 100mg of sulpiride 30min before PEG. Receives: Drug: sulpiride |
| Control group | No intervention | Patients in Control group followed the regular routine of 3L split-dose of PEG. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of the discomforts during bowel preparation
The primary endpoint of this study was the discomforts during bowel preparation such as nausea, vomit, abdominal fullness and pain. These symptoms were assessed as none, mild, moderate and severe. Patients with mild to severe symptoms were classified as presence of discomforts.
Measured: before colonoscopy
Secondary outcomes (1)
The quality of bowel preparation assessed by Boston Bowel Preparation Scale
The secondary endpoint was the quality of bowel preparation assessed by the Boston Bowel Preparation Scale (BBPS) during the withdrawal phase of colonoscopy. The BBPS uses a 0-3 points scale assessing the bowel preparation quality in 3 segments of the colon (the right, transverse and left colons). BBPS score ≥ 6 were defined as adequate bowel preparation.
Measured: during colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start1 Mar 2020
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel PreparationStudies of the same condition, open and under way.
- More trials run by RenJi 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengliang Chen, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583111
- Sponsor's protocol ID
- RJYYXHNK-006
- Status last verified
- Sep 2020
- First submitted
- 22 Sep 2020
- Last updated
- 12 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Antiemetics on Bowel Preparation Before Colonoscopy
- ClinicalTrials.gov ID
- NCT04583111
- Acronym / sponsor ID
- RJYYXHNK-006
- Conditions
- Bowel Preparation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 12 Oct 2020 (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.
Polyethylene glycol (PEG) is one of the most common laxatives used in colonoscopy. However, 5 - 15% of patients can not complete the preparation due to its poor taste and large volume. So this study is aimed to explore the effect of antiemetics on abdominal discomforts associated with PEG.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Domperidone group | Experimental | Drug: DomperidonePatients in Domperidone group took 10mg of domperidone 30min before PEG. |
| Sulpiride group | Experimental | Drug: sulpiridePatients in Sulpiride group took 100mg of sulpiride 30min before PEG. |
| Control group | No intervention | –Patients in Control group followed the regular routine of 3L split-dose of PEG. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-70 years patients scheduled for colonoscopy
Key exclusion criteria (4 listed)
- intestinal obstruction or hemorrhage;
- allergy to domperidone, sulpiride or PEG;
- pregnancy or breastfeeding;
- previous use of prokinetics within 1 month.
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 |
|---|---|---|
| DomperidoneDomperidone and sulpiride are antiemetics that may be useful in preventing the PEG-related nausea and vomiting. | Drug | Domperidone group |
| sulpirideDomperidone and sulpiride are antiemetics that may be useful in preventing the PEG-related nausea and vomiting. | Drug | Sulpiride group |
Primary outcome
Incidence of the discomforts during bowel preparation
Time frame: before colonoscopy
The primary endpoint of this study was the discomforts during bowel preparation such as nausea, vomit, abdominal fullness and pain. These symptoms were assessed as none, mild, moderate and severe. Patients with mild to severe symptoms were classified as presence of discomforts.
1 secondary outcome
The quality of bowel preparation assessed by Boston Bowel Preparation Scale
Time frame: during colonoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Domperidone and sulpiride in people with Bowel Preparation, run by RenJi 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 1 inclusion and 4 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 12 Oct 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shengliang Chen, Dr (02158752345, slchenmd@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of the discomforts during bowel preparation (time frame: before colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Oct 2020.