Polyethylene GlycolPhase 4NCT03817788
Randomized Controlled Trail of Polyethylene Glycol vs Sodium Phosphate for Colonic Cleansing of Colonoscopy
A Phase 4 study testing polyethylene glycol and sodium phosphate in people with Polyethylene Glycol and Sodium Phosphate, run by Dong Yang at 1 site in China.
Trial summary
This study is to compare polyethylene glycol and sodium phosphate for colonic cleansing of colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Polyethylene Glycol, Sodium Phosphate
- What is being tested?
- polyethylene glycol and sodium phosphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 586 participants
- Where
- 1 siteChina
- Study dates
- 26 Apr 2019to 12 Apr 2020
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Outpatients meet the following criteria: 1) age 18-60 years; 2) BMI 18.9-28; 3) Heart, lung, liver, and kidney function can tolerate colonoscopy; 4) Patients and their families are able to understand and be willing to participate in this clinical study and to sign informed consent
Who cannot join
- 1) colorectal surgery history (except appendectomy); 2) patients with intestinal obstruction, incomplete obstruction, intestinal hemorrhage; 3) patients with renal insufficiency; 4) patients with hirschsprung disease; 5) patients with inflammatory bowel disease during active period, which affects intestinal observation; 6) patients who are bedridden and lose the moving ability ; 7) have a history of severe mental illness; 8) pregnant or lactating women; 9) patients with other clinical conditions considered by some researchers should not participate in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
This study is to compare polyethylene glycol and sodium phosphate for colonic cleansing of colonoscopy.
- Conditions
- Polyethylene Glycol, Sodium Phosphate
- Being tested
- polyethylene glycol, sodium phosphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyethylene glycolDrug
All patients should receive dietary guidance, and eat a low-residue diet three days before colonoscopy. For polyethylene glycol group (group P): the day before colonoscopy, 750 mL (1 box) of polyethylene glycol solution should be drunk 2 hours after dinner; the other 1500 ml (2 boxes) of polyethylene glycol solution should be taken 4-6 hours before the examination. After oral laxatives were finished, 20 ml dimethicone would be taken orally as defoamer. All the enteroscopy should by performed by the same juniar clinician, and related indicators were recorded.
sodium phosphateDrug
All patients should receive dietary guidance, and eat a low-residue diet three days before colonoscopy. For sodium phosphate group (group S), 750 mL (1 box) of sodium phosphate solution should be drunk 2 hours after dinner; and the other 750 mL (1 box) of sodium phosphate solution should be taken 4-6 hours before the examination. After oral laxatives were finished, 20 ml dimethicone would be taken orally as defoamer. All the enteroscopy should by performed by the same clinician, and related indicators were recorded.
| Study group | Role | What they receive |
|---|---|---|
| polyethylene glycol group (group P) | Active comparator | For all patients of this group, polyethylene glycol solution should be taken orally for colonic cleansing of colonoscopy Receives: Drug: polyethylene glycol |
| sodium phosphate group (group S) | Experimental | For all patients of this group, sodium phosphate solution should be taken orally for colonic cleansing of colonoscopy Receives: Drug: sodium phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cleansing quality
The quality of colon cleansing was assessed by the endoscopist with Boston bowel preparation scale.
Measured: during the procedure of colonoscopy
Secondary outcomes (5)
the duration of the procedure
time to cecal intubation and withdrawal time
Measured: during the procedure of colonoscopy
patient tolerance
patient tolerance about oral laxatives.
Measured: before the procedure of colonoscopy
the degree of difficulty of the procedure
6-point scale: extremely easy, easy, fairly easy, fairly difficult, difficult, extremely difficult
Measured: at the end of the procedure of colonoscopy
polyps or other endoscopic lesions
For polyps or other endoscopic lesions, a histopathologic diagnosis was systematically obtained and recorded
Measured: at the end of the procedure of colonoscopy
patient pain
(visual analog scale, 0-10).
Measured: at the end of the procedure of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start26 Apr 2019
- Primary completion2 Apr 2020
- Study completion12 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyethylene GlycolStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 586 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong Yang
- Sponsor type
- University, hospital or other
- Collaborators
- Xu Hong
- Responsible party
- Sponsor-investigator, Dong Yang, Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817788
- Sponsor's protocol ID
- 130022
- Status last verified
- Apr 2020
- First submitted
- 23 Jan 2019
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trail of Polyethylene Glycol vs Sodium Phosphate for Colonic Cleansing of Colonoscopy
- ClinicalTrials.gov ID
- NCT03817788
- Acronym / sponsor ID
- 130022
- Conditions
- Polyethylene Glycol, Sodium Phosphate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 586 participants (actual)
- Lead sponsor
- Dong YangUniversity, hospital or other
- Collaborators
- Xu Hong
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 2 Apr 2020 (actual)
- Study completion
- 12 Apr 2020 (actual)
- First posted
- 25 Jan 2019 (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 study is to compare polyethylene glycol and sodium phosphate for colonic cleansing of colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| polyethylene glycol group (group P) | Active comparator | Drug: polyethylene glycolFor all patients of this group, polyethylene glycol solution should be taken orally for colonic cleansing of colonoscopy |
| sodium phosphate group (group S) | Experimental | Drug: sodium phosphateFor all patients of this group, sodium phosphate solution should be taken orally for colonic cleansing of colonoscopy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Outpatients meet the following criteria: 1) age 18-60 years; 2) BMI 18.9-28; 3) Heart, lung, liver, and kidney function can tolerate colonoscopy; 4) Patients and their families are able to understand and be willing to participate in this clinical study and to sign informed consent
Key exclusion criteria (1 listed)
- 1) colorectal surgery history (except appendectomy); 2) patients with intestinal obstruction, incomplete obstruction, intestinal hemorrhage; 3) patients with renal insufficiency; 4) patients with hirschsprung disease; 5) patients with inflammatory bowel disease during active period, which affects intestinal observation; 6) patients who are bedridden and lose the moving ability ; 7) have a history of severe mental illness; 8) pregnant or lactating women; 9) patients with other clinical conditions considered by some researchers should not participate in the trial.
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 |
|---|---|---|
| polyethylene glycolAll patients should receive dietary guidance, and eat a low-residue diet three days before colonoscopy. For polyethylene glycol group (group P): the day before colonoscopy, 750 mL (1 box) of polyethylene glycol solution should be drunk 2 hours after dinner; the other 1500 ml (2 boxes) of polyethylene glycol solution should be taken 4-6 hours before the examination. After oral laxatives were finished, 20 ml dimethicone would be taken orally as defoamer. All the enteroscopy should by performed by the same juniar clinician, and related indicators were recorded. | Drug | polyethylene glycol group (group P) |
| sodium phosphateAll patients should receive dietary guidance, and eat a low-residue diet three days before colonoscopy. For sodium phosphate group (group S), 750 mL (1 box) of sodium phosphate solution should be drunk 2 hours after dinner; and the other 750 mL (1 box) of sodium phosphate solution should be taken 4-6 hours before the examination. After oral laxatives were finished, 20 ml dimethicone would be taken orally as defoamer. All the enteroscopy should by performed by the same clinician, and related indicators were recorded. | Drug | sodium phosphate group (group S) |
Primary outcome
Cleansing quality
Time frame: during the procedure of colonoscopy
The quality of colon cleansing was assessed by the endoscopist with Boston bowel preparation scale.
5 secondary outcomes
the duration of the procedure
Time frame: during the procedure of colonoscopy
patient tolerance
Time frame: before the procedure of colonoscopy
the degree of difficulty of the procedure
Time frame: at the end of the procedure of colonoscopy
polyps or other endoscopic lesions
Time frame: at the end of the procedure of colonoscopy
patient pain
Time frame: at the end of the procedure of colonoscopy
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 17 Apr 2020.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 polyethylene glycol and sodium phosphate in people with Polyethylene Glycol and Sodium Phosphate, run by Dong Yang 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 1 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 17 Apr 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?
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?
Cleansing quality (time frame: during the procedure of 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 17 Apr 2020.