Bowel Preparation ScalePhase 4NCT03352700
Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy
A Phase 4 study testing 3L PEG and 3L PEG+Dyclonine Hydrochloride Mucilage in people with Bowel Preparation Scale and the Amount of Air Bubble, run by Changhai Hospital at 1 site in China.
Trial summary
In this randomized controlled study, consecutive outpatients scheduled for elective colonoscopy were randomized into two groups. Group A patients (n = 300) used only 3L PEG before 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 Scale, the Amount of Air Bubble, Adenoma Detection Rate
- What is being tested?
- 3L PEG and 3L PEG+Dyclonine Hydrochloride Mucilage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 580 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 1 Feb 2018
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients are between 18-75 years old
- undergoing colonoscopy for diagnostic investigation, colorectal cancer screening or follow-up
Who cannot join
- suspected gastrointestinal obstruction or perforation
- severe acute inflammatory bowel disease
- toxic megacolon
- ileus or gastric retention, ileostomy,
- hypersensitivity to any of the ingredients
- pregnancy and lactation and/or at a risk of becoming pregnant
Trial locations and contacts
1 site in 1 country.
China1 site
Changhai Hospital, Second Military Medical University
Shanghai, 200433
About this study
In this randomized controlled study, consecutive outpatients scheduled for elective colonoscopy were randomized into two groups. Group A patients (n = 300) used only 3L PEG before colonoscopy. Patients in group B (n = 300) were additionally advised to Dyclonine Hydrochloride Mucilage plus 3L PEG, The overall quality of colonoscopy cleaning was evaluated using the Boston Bowel Preparation Scale by a single endoscopist who was blinded to the intervention. Visibility was blindly assessed for the amount of air bubbles and adenoma detection rate (ADR). Difficulty of procedure, and adverse events were also evaluated.
- Being tested
- 3L PEG, 3L PEG+Dyclonine Hydrochloride Mucilage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3L PEGDrug
Group A patients (n = 300) used only 3L PEG before colonoscopy.
3L PEG+Dyclonine Hydrochloride MucilageDrug
Patients in group B (n = 300) were additionally advised to Dyclonine Hydrochloride Mucilage plus 3 L PEG
| Study group | Role | What they receive |
|---|---|---|
| 3L PEG | Placebo comparator | only used 3L PEG Receives: Drug: 3L PEG |
| 3L PEG+Dyclonine Hydrochloride Mucilage | Experimental | used 3L PEG+Dyclonine Hydrochloride Mucilage Receives: Drug: 3L PEG+Dyclonine Hydrochloride Mucilage |
What is being measured
The primary outcome is the main question the study is designed to answer.
the amount of air bubbles
The amount of intraluminal air bubbles was classified into four grades as shown below: Grade 0 = No or minimal scattered bubbles; Grade 1 = Bubbles covering at least half the luminal diameter; Grade 2 = Bubbles covering the circumference of the lumen; Grade 3 = Bubbles filling the entire lumen. Bubbles filling the entire lumen.
Measured: 2 days
Secondary outcomes (2)
adenoma detection rate
The secondary end point of the study included adenoma detection rate
Measured: 2 days
mean total adenomas detected beyond first
It was a new metric called ADR-Plus, the mean number of incremental adenomas after the fist.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start1 Dec 2017 (estimated)
- Primary completion1 Jan 2018 (estimated)
- Study completion1 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel Preparation ScaleStudies 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 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Peng Cheng, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352700
- Sponsor's protocol ID
- Dyclonine-01
- Status last verified
- Nov 2017
- First submitted
- 21 Nov 2017
- Last updated
- 24 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy
- ClinicalTrials.gov ID
- NCT03352700
- Acronym / sponsor ID
- Dyclonine-01
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 1 Jan 2018 (estimated)
- Study completion
- 1 Feb 2018 (estimated)
- First posted
- 24 Nov 2017 (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.
In this randomized controlled study, consecutive outpatients scheduled for elective colonoscopy were randomized into two groups. Group A patients (n = 300) used only 3L PEG before colonoscopy. Patients in group B (n = 300) were additionally advised to Dyclonine Hydrochloride Mucilage plus 3L PEG, The overall quality of colonoscopy cleaning was evaluated using the Boston Bowel Preparation Scale by a single endoscopist who was blinded to the intervention. Visibility was blindly assessed for the amount of air bubbles and adenoma detection rate (ADR). Difficulty of procedure, and adverse events were also evaluated.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3L PEG | Placebo comparator | Drug: 3L PEGonly used 3L PEG |
| 3L PEG+Dyclonine Hydrochloride Mucilage | Experimental | Drug: 3L PEG+Dyclonine Hydrochloride Mucilageused 3L PEG+Dyclonine Hydrochloride Mucilage |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients are between 18-75 years old
- undergoing colonoscopy for diagnostic investigation, colorectal cancer screening or follow-up
Key exclusion criteria (6 listed)
- suspected gastrointestinal obstruction or perforation
- severe acute inflammatory bowel disease
- toxic megacolon
- ileus or gastric retention, ileostomy,
- hypersensitivity to any of the ingredients
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 |
|---|---|---|
| 3L PEGGroup A patients (n = 300) used only 3L PEG before colonoscopy. | Drug | 3L PEG |
| 3L PEG+Dyclonine Hydrochloride MucilagePatients in group B (n = 300) were additionally advised to Dyclonine Hydrochloride Mucilage plus 3 L PEG | Drug | 3L PEG+Dyclonine Hydrochloride Mucilage |
Primary outcome
the amount of air bubbles
Time frame: 2 days
The amount of intraluminal air bubbles was classified into four grades as shown below: Grade 0 = No or minimal scattered bubbles; Grade 1 = Bubbles covering at least half the luminal diameter; Grade 2 = Bubbles covering the circumference of the lumen; Grade 3 = Bubbles filling the entire lumen. Bubbles filling the entire lumen.
2 secondary outcomes
adenoma detection rate
Time frame: 2 days
mean total adenomas detected beyond first
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
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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.
Peng Cheng 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 4 study testing 3L PEG and 3L PEG+Dyclonine Hydrochloride Mucilage in people with Bowel Preparation Scale and the Amount of Air Bubble, 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 2 inclusion and 6 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 24 Nov 2017. 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. Some participants in this study may receive a placebo. 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 Zhaosheng Li, MD (+86-21-31161335, zhaoshenlismmu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the amount of air bubbles (time frame: 2 days). 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 24 Nov 2017.