Bowel PreparationPhase 4NCT04483037
Different Dosing Time of Bowklean for the Bowel Preparation
A Phase 4 study testing Bowklean in people with Bowel Preparation, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
The primary objective of this study is to compare the efficacy of administration routine bowel cleansing medication (Bowklean) for the Bowel Preparation at Different Times Prior Colonoscopy in the morning or in the afternoon. Read more about this study
- Who is it for?
- Ages 20 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- Bowklean
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 297 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2019to 31 Dec 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 20 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is 20 and 99 years, inclusive.
- Men or non-pregnant women who are scheduled for an elective colonoscopy.
- Subjects should be willing, able to complete the entire procedure and to comply with study instructions.
- Written informed consent obtained prior to study.
Who cannot join
- Patients who are not suitable for colonoscopy
- Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.)
- Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
- Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudo- obstruction, hypomotility syndrome)
- Gastrointestinal disorder (active ulcer, outlet obstruction, gastric retention, gastroparesis, ileus)
- Uncontrolled angina and/or Myocardial Infarction (MI) within last 3 months before randomization, Congestive Heart Failure (CHF), arrhythmia, cardiomyopathy or uncontrolled hypertension
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- Renal insufficiency
- Any prior colorectal surgery
- in the past 3 months, excluding appendectomy, hemorrhoid surgery or prior endoscopic procedures
- History of upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)
- Severe chronic constipation
- Hypersensitivity to any ingredient in the study medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Same-Day and Split-Dose Preparation With Sodium Picosulfate/Magnesium Citrate (Bowklean) for Afternoon Colonoscopy: A Randomized Non-Inferiority Study
The primary objective of this study is to compare the efficacy of administration routine bowel cleansing medication (Bowklean) for the Bowel Preparation at Different Times Prior Colonoscopy in the morning or in the afternoon.
Read the detailed description
Sodium picosulfate/magnesium citrate (SPMC) is a small-volume bowel cleansing agent with similar efficacy and better tolerability than polyethylene glycol. However, there was limited data about the bowel cleansing efficacy of SPMC in comparing the same-day and split-dose preparation for afternoon colonoscopy.
This randomized, single-center, endoscopist-blinded, non-inferior study compared same-day (101 subjects) and split-dose (96 subjects) preparation with SPMC for afternoon colonoscopy. One additional prospective observation group of 100 subjects receiving colonoscopy in the morning was included as an observation group to compare bowel preparation in morning and afternoon colonoscopy. Efficacy of bowel cleansing was evaluated by the Aronchick Scale, Ottawa Bowel Preparation Scale (OBPS), Boston Bowel Preparation Scale (BBPS), and the Bubble Scale (TBS).
- Conditions
- Bowel Preparation
- Being tested
- Bowklean
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BowkleanDrug
assigned intervention
| Study group | Role | What they receive |
|---|---|---|
| split dose, day before, colonoscopy in the morning (Observation Group) | Active comparator | routine bowel preparation before colonoscopy in the morning Receives: Drug: Bowklean |
| split dose, day before, colonoscopy in the afternoon (Random) | Active comparator | routine bowel preparation before colonoscopy in the afternoon Receives: Drug: Bowklean |
| two dose in the same day, colonoscopy in the afternoon (Random) | Experimental | experimental group Receives: Drug: Bowklean |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aronchick Scale Bowel Cleaning Scale
Aroochick Scale ranges from score 1 : excellent, 2: good, 3: fair, 4: poor 5: failed
Measured: during colonoscopy
Secondary outcomes (2)
Boston Bowel Preparation Scale (BBPS) Bowel Cleaning Scale
The Boston Bowel Preparation Scale Score 0 : inadequate ; Score 1: fair ;Score 2: good; Score 3: excellent . min : 0 , max: 3
Measured: During Colonoscopy
Colonscopy Bubble Scale
Colon Bubble Scale : Grade A : no bubble , Grade B: little bubble , Grade C: bubble of half of the lumen , Grade D: bubble of entire lumen. Grade A means the best and Grade D means the worst.
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 posted23 Jul 2020
- Study start1 Jan 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The 1st group: split dose, day before, colonoscopy in the morning. The 2nd group: split dose, day before, colonoscopy in the afternoon. The 3rd group: same day, colonoscopy in the afternoon.
- Masking
- None (open label)
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HSUHENG YEN, Changhua Christian Hospital
- Investigators
- HsuHeng Yen, MD, Principal investigator, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483037
- Sponsor's protocol ID
- CCH IRB No.: 181216
- Status last verified
- Jul 2021
- First submitted
- 20 Jul 2020
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Same-Day and Split-Dose Preparation With Sodium Picosulfate/Magnesium Citrate (Bowklean) for Afternoon Colonoscopy: A Randomized Non-Inferiority Study
- ClinicalTrials.gov ID
- NCT04483037
- Acronym / sponsor ID
- CCH IRB No.: 181216
- Conditions
- Bowel Preparation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 23 Jul 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.
The primary objective of this study is to compare the efficacy of administration routine bowel cleansing medication (Bowklean) for the Bowel Preparation at Different Times Prior Colonoscopy in the morning or in the afternoon.
Detailed description
Sodium picosulfate/magnesium citrate (SPMC) is a small-volume bowel cleansing agent with similar efficacy and better tolerability than polyethylene glycol. However, there was limited data about the bowel cleansing efficacy of SPMC in comparing the same-day and split-dose preparation for afternoon colonoscopy.
This randomized, single-center, endoscopist-blinded, non-inferior study compared same-day (101 subjects) and split-dose (96 subjects) preparation with SPMC for afternoon colonoscopy. One additional prospective observation group of 100 subjects receiving colonoscopy in the morning was included as an observation group to compare bowel preparation in morning and afternoon colonoscopy. Efficacy of bowel cleansing was evaluated by the Aronchick Scale, Ottawa Bowel Preparation Scale (OBPS), Boston Bowel Preparation Scale (BBPS), and the Bubble Scale (TBS).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The 1st group: split dose, day before, colonoscopy in the morning. The 2nd group: split dose, day before, colonoscopy in the afternoon. The 3rd group: same day, colonoscopy in the afternoon.
| Arm | Type | Receives |
|---|---|---|
| split dose, day before, colonoscopy in the morning (Observation Group) | Active comparator | Drug: Bowkleanroutine bowel preparation before colonoscopy in the morning |
| split dose, day before, colonoscopy in the afternoon (Random) | Active comparator | Drug: Bowkleanroutine bowel preparation before colonoscopy in the afternoon |
| two dose in the same day, colonoscopy in the afternoon (Random) | Experimental | Drug: Bowkleanexperimental group |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is 20 and 99 years, inclusive.
- Men or non-pregnant women who are scheduled for an elective colonoscopy.
- Subjects should be willing, able to complete the entire procedure and to comply with study instructions.
- Written informed consent obtained prior to study.
Key exclusion criteria (12 listed)
- Patients who are not suitable for colonoscopy
- Any prior colorectal surgery
- Severe chronic constipation
- Hypersensitivity to any ingredient in the study medication
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 |
|---|---|---|
| Bowkleanassigned intervention | Drug | split dose, day before, colonoscopy in the afternoon (Random), split dose, day before, colonoscopy in the morning (Observation Group), two dose in the same day, colonoscopy in the afternoon (Random) |
Primary outcome
Aronchick Scale Bowel Cleaning Scale
Time frame: during colonoscopy
Aroochick Scale ranges from score 1 : excellent, 2: good, 3: fair, 4: poor 5: failed
2 secondary outcomes
Boston Bowel Preparation Scale (BBPS) Bowel Cleaning Scale
Time frame: During Colonoscopy
Colonscopy Bubble Scale
Time frame: During 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 23 Jul 2021.
- Individual participant dataSharing planned: No
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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.
HsuHeng Yen, MD principal investigator
Changhua Christian 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 Bowklean in people with Bowel Preparation, run by Changhua Christian Hospital at 1 site in Taiwan.
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 4 inclusion and 12 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 23 Jul 2021. 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 Taiwan. 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?
Aronchick Scale Bowel Cleaning Scale (time frame: during 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 23 Jul 2021.