Colorectal CancerPhase 3NCT02548403
Effect of Simethicone on Bowel Preparation for Colonoscopy
A Phase 3 study testing PEG-Asc and PEG-Asc with simethicone in people with Colorectal Cancer, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
Optimal bowel preparation is essential for colonoscopy efficacy and safety. Mucosal visualization during colonoscopy is often limited by residual stool, bubbles, bile, intraluminal fluid, and debris, which increase the risk of missing flat adenomas or other small lesions.Therefore, intestinal preparation is necessary… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- PEG-Asc and PEG-Asc with simethicone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Nov 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients,
- aged between18 and 80 years undergoing elective outpatient colonoscopy were eligible for the study
Who cannot join
- patients who had chronic kidney disease,
- severe heart failure(New York Heart Association [NYHA] class III or IV)
- uncontrolled hypertension (systolic pressure ≥170 mm Hg, diastolic pressure ≥100 mm Hg)
- severe constipation
- any bowel resection
- significant gastroparesis, or
- suspected bowel obstruction or perforation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Simethicone to Improve the Bowel Cleansing Effects of Polyethylene Glycol With Ascorbic Acid for Colonoscopy
Optimal bowel preparation is essential for colonoscopy efficacy and safety. Mucosal visualization during colonoscopy is often limited by residual stool, bubbles, bile, intraluminal fluid, and debris, which increase the risk of missing flat adenomas or other small lesions.Therefore, intestinal preparation is necessary to remove residual materials prior to endoscopy.
A combined agent, low-dose PEG with ascorbic acid (PEG-Asc), is one low-volume solution commonly used in Korea (Coolprep®; TaeJoon Pharmaceuticals, Seoul, Korea). However, practitioners have noted an increased incidence of bubble formation with this preparation method.
Read more
To the investigators knowledge, no previous study has assessed colon preparation in patients administered simethicone.
The purpose of this study was to compare the quality of bowel preparation and compliance between PEG-Asc and PEG-Asc with simethicone. The effectiveness of adding simethicone as an antifoaming agent to improve bowel cleansing for colonoscopy was evaluated in terms of bowel preparation scale and bubble score, and the compliance of both patients and endoscopists was also investigated using a questionnaire.
Read the detailed description
- Study design: endoscopist-blinded, prospective, randomized controlled trial
- Subjects
- A single-center, randomized, observer-blinded study was performed at Korea University Hospital in Anam. Outpatients were prospectively enrolled. Each group of the patients will receive PEG-Asc or PEG-Asc with simethicone before colonoscopy.
- Sampling design: Consecutive recruitment of consenting patients
- Variables Predictor
- group 1 (PEG-Asc) received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure;
- group 2 (PEG-Asc with simethicone) received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure;Two packs (200 mg/10 mL each) of simethicone (400 mg) was mixed with last 500 mL of additional clear fluid.
- Primary Outcome: Quality of bowel preparation [Boston Bowel Preparation Scale, bubble score]
- Secondary Outcome: Patients and endoscopists' compliance[Tolerability, palatability of patient, fatigue score of endoscopist]
- Conditions
- Colorectal Cancer
- Being tested
- PEG-Asc, PEG-Asc with simethicone
- Keywords
- Bowel preparation, Simethicone, Polyethylene glycol with ascorbic acid
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-AscDrug
Also called •Coolprep®; TaeJoon Pharmaceuticals, Seoul, Korea
received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure
PEG-Asc with simethiconeDrug
Also called Coolprep with gasocol® ; TaeJoon Pharmaceuticals, Korea
received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure. Two packs (200 mg/10 mL each) of simethicone (400 mg) was mixed with last 500 mL of additional clear fluid.
| Study group | Role | What they receive |
|---|---|---|
| PEG-Asc | Active comparator | group 1 (PEG-Asc, N=130) received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure Receives: Drug: PEG-Asc; Drug: PEG-Asc with simethicone |
| PEG-Asc with simethicone | Active comparator | group 2 (PEG-Asc with simethicone, N=130) received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure.Two packs (200 mg/10 mL each) of simethicone (400 mg) was mixed with last 500 mL of additional clear fluid. Receives: Drug: PEG-Asc; Drug: PEG-Asc with simethicone |
What is being measured
The primary outcome is the main question the study is designed to answer.
the quality of the bowel preparation using Preparation Scale
Preparation Scale
Preparation Scale
Measured: 20 minutes
Secondary outcomes (3)
Completeness of the bowel preparation
Patient compliance was recorded by checking the completeness of the prescribed preparation methods including bowel cleansing agent solution and recommended clear liquid.
Measured: 10 minutes
the patient's tolerability[questionnaire]
Patients were asked with questionnaires about the symptoms associated with the preparation to assess the patients' tolerability before the colonoscopy. Patients were asked whether they experienced any of the following : abdominal fullness, cramping, nausea, vomiting, sleep disturbance, and overall discomfort, and these symptoms were scored on a 5-point scale where 1 = "none", 2 = "mild", 3 = "moderate", 4 = "severe", and 5 = "very severe".
Measured: 30 minutes before the colonoscopy
the endoscopist's tolerability[Visual Analog Score for fatigue]
Endoscopist fatigue during colonoscopy was scored using a Visual Analog Scale, ranging from 1-10, where 1 and 10 represented "strongly disagree" and "strongly agree", respectively.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startJul 2014
- Primary completionSep 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Kyung Yoo, Korea University Anam Hospital
- Investigators
- In kyung Yoo, MD, Principal investigator, Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548403
- Sponsor's protocol ID
- Korea University Prep1
- Status last verified
- Sep 2015
- First submitted
- 8 Sep 2015
- Last updated
- 14 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Simethicone to Improve the Bowel Cleansing Effects of Polyethylene Glycol With Ascorbic Acid for Colonoscopy
- ClinicalTrials.gov ID
- NCT02548403
- Acronym / sponsor ID
- Korea University Prep1
- Conditions
- Colorectal Cancer
- Keywords
- Bowel preparation, Simethicone, Polyethylene glycol with ascorbic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 14 Sep 2015 (estimated)
- 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.
Optimal bowel preparation is essential for colonoscopy efficacy and safety. Mucosal visualization during colonoscopy is often limited by residual stool, bubbles, bile, intraluminal fluid, and debris, which increase the risk of missing flat adenomas or other small lesions.Therefore, intestinal preparation is necessary to remove residual materials prior to endoscopy.
A combined agent, low-dose PEG with ascorbic acid (PEG-Asc), is one low-volume solution commonly used in Korea (Coolprep®; TaeJoon Pharmaceuticals, Seoul, Korea). However, practitioners have noted an increased incidence of bubble formation with this preparation method.
To the investigators knowledge, no previous study has assessed colon preparation in patients administered simethicone.
The purpose of this study was to compare the quality of bowel preparation and compliance between PEG-Asc and PEG-Asc with simethicone. The effectiveness of adding simethicone as an antifoaming agent to improve bowel cleansing for colonoscopy was evaluated in terms of bowel preparation scale and bubble score, and the compliance of both patients and endoscopists was also investigated using a questionnaire.
Detailed description
- Study design: endoscopist-blinded, prospective, randomized controlled trial
- Subjects
- A single-center, randomized, observer-blinded study was performed at Korea University Hospital in Anam. Outpatients were prospectively enrolled. Each group of the patients will receive PEG-Asc or PEG-Asc with simethicone before colonoscopy.
- Sampling design: Consecutive recruitment of consenting patients
- Variables Predictor
- group 1 (PEG-Asc) received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure;
- group 2 (PEG-Asc with simethicone) received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure;Two packs (200 mg/10 mL each) of simethicone (400 mg) was mixed with last 500 mL of additional clear fluid.
- Primary Outcome: Quality of bowel preparation [Boston Bowel Preparation Scale, bubble score]
- Secondary Outcome: Patients and endoscopists' compliance[Tolerability, palatability of patient, fatigue score of endoscopist]
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-Asc | Active comparator | Drug: PEG-Asc, Drug: PEG-Asc with simethiconegroup 1 (PEG-Asc, N=130) received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure |
| PEG-Asc with simethicone | Active comparator | Drug: PEG-Asc, Drug: PEG-Asc with simethiconegroup 2 (PEG-Asc with simethicone, N=130) received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure.Two packs (200 mg/10 mL each) of simethicone (400 mg) was mixed with last 500 mL of additional clear fluid. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female patients,
- aged between18 and 80 years undergoing elective outpatient colonoscopy were eligible for the study
Key exclusion criteria (7 listed)
- patients who had chronic kidney disease,
- severe heart failure(New York Heart Association [NYHA] class III or IV)
- uncontrolled hypertension (systolic pressure ≥170 mm Hg, diastolic pressure ≥100 mm Hg)
- severe constipation
- any bowel resection
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 |
|---|---|---|
| PEG-AscAlso: •Coolprep®; TaeJoon Pharmaceuticals, Seoul, Koreareceived 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure | Drug | PEG-Asc, PEG-Asc with simethicone |
| PEG-Asc with simethiconeAlso: Coolprep with gasocol® ; TaeJoon Pharmaceuticals, Koreareceived 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure. Two packs (200 mg/10 mL each) of simethicone (400 mg) was mixed with last 500 mL of additional clear fluid. | Drug | PEG-Asc, PEG-Asc with simethicone |
Primary outcome
the quality of the bowel preparation using Preparation Scale
Time frame: 20 minutes
Preparation Scale Preparation Scale
3 secondary outcomes
Completeness of the bowel preparation
Time frame: 10 minutes
the patient's tolerability[questionnaire]
Time frame: 30 minutes before the colonoscopy
the endoscopist's tolerability[Visual Analog Score for fatigue]
Time frame: 10 minutes
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 14 Sep 2015.
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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.
In kyung Yoo, MD principal investigator
Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea
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 PEG-Asc and PEG-Asc with simethicone in people with Colorectal Cancer, run by Korea University Anam Hospital at 1 site in South Korea.
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 7 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 14 Sep 2015. 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 South Korea. 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?
the quality of the bowel preparation using Preparation Scale (time frame: 20 minutes). 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 14 Sep 2015.