Bowel Preparation Before ColonoscopyPhase 3NCT01984008
A Study of the Efficacy and Safety of Bowklean and Klean-Prep With Dulcolax for the Bowel Preparation Prior Colonoscopy
A Phase 3 study testing Picosulfate sodium, magnesium oxide, citric acid in people with Bowel Preparation Before Colonoscopy, run by Universal Integrated Corp. at 1 site in Taiwan.
Trial summary
The primary objective of this study is to demonstrate that investigation medication (Bowklean) is not less effective than the active comparator (Klean-Prep with Dulcolax), with regards to the overall quality of bowel preparation in subjects undergoing colonoscopy. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation Before Colonoscopy
- What is being tested?
- Picosulfate sodium, magnesium oxide, citric acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 631 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Oct 2013to 17 Jun 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is 20 and 80 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
- 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)
- 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)
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- Severe chronic constipation
- Ascites
- Renal insufficiency ((serum creatinine > 1.5 times the upper limit of normal (ULN))creatinine clearance < 30 mL/min)
- Uncontrolled angina and/or Myocardial Infarction (MI) within last 3 months before randomization, Congestive Heart Failure (CHF), or uncontrolled hypertension
- Participation in an investigational study within 60 days prior to receiving study medication
- Any clinically significant laboratory value at screening, including pre-existing electrolyte abnormality, based on clinical history that the Investigator feels may affect the study evaluation
- Hypersensitivity to any ingredient in the study medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized Controlled Clinical Study of the Efficacy and Safety of Bowklean and Klean-Prep With Dulcolax for the Bowel Preparation Prior Colonoscopy
The primary objective of this study is to demonstrate that investigation medication (Bowklean) is not less effective than the active comparator (Klean-Prep with Dulcolax), with regards to the overall quality of bowel preparation in subjects undergoing colonoscopy. An additional objective of this study is to collect subject's response to the acceptability and tolerability about bowel preparation and safety information.
After bowel preparation, independent evaluator who is blinded to subject's treatment will evaluate the overall colon cleansing based on Aronchick and Ottawa scale. A total of 600 eligible subjects scheduled to a colonoscopy will be randomly assigned with equal allocation to 1 of 2 treatment groups: "Bowklean" or "Klean-Prep" with Dulcolax. Each subject's participation is expected to be maximally 4 weeks in study duration (up to 3-week screening period followed by one week post colonoscopy).
Read the detailed description
The objective of this study was to demonstrate that investigational medication (Bowklean) is not less effective than the active comparator (Klean-Prep with Dulcolax), with regards to the overall quality of bowel preparation in subjects undergoing colonoscopy. It was designed to measure the number of subjects whose colons are cleansed successfully.
The primary efficacy endpoint is the percentage of subjects that achieve excellent or good cleansing (success rate) in the Aronchick Scale.
The secondary efficacy variables include:
- Proportion of successes (excellent, good, or fair) by individual colon segment (ascending, transverse, descending), which are assessed with the Ottawa scale6.
- Mean bowel preparation score assessed with Ottawa Scale by adding points for the cleansing of three parts of colon and points for amount of fluid in the bowel.
- Percentage of subject's responses to the acceptability and tolerability
Safety was assessed at each clinic visit by evaluation of the following variables:
- Percentage of subjects occurred solicited event (nausea, vomiting, chest pain and dizziness) during the preparation.
- Percentage of subjects with treatment-emergent adverse events during the study period.
- Conditions
- Bowel Preparation Before Colonoscopy
- Being tested
- Picosulfate sodium, magnesium oxide, citric acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Picosulfate sodium, magnesium oxide, citric acidDrug
| Study group | Role | What they receive |
|---|---|---|
| picosulfate,MgO, citric acid, bowel preparation, powder | Experimental | colonoscopy picosulfate,MgO, citric acid, bowel preparation, powder Receives: Drug: Picosulfate sodium, magnesium oxide, citric acid |
| polyethylene glycol, bisacodyl, | Active comparator | colonoscopy polyethylene glycol,powder bisacodyl,tablet Receives: Drug: Picosulfate sodium, magnesium oxide, citric acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of subjects that achieve excellent or good cleansing (success rate) in the Aronchick Scale.
Measured: six months
Secondary outcomes (1)
Proportion of successes (excellent, good, or fair) by individual colon segment (ascending, transverse, descending), which are assessed with the Ottawa scale.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study start23 Oct 2013
- Primary completion24 Mar 2014
- Study completion17 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel Preparation Before ColonoscopyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 631 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universal Integrated Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984008
- Sponsor's protocol ID
- UIC-BKL-2013
- Status last verified
- Mar 2020
- First submitted
- 24 Oct 2013
- Last updated
- 30 Mar 2020
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Clinical Study of the Efficacy and Safety of Bowklean and Klean-Prep With Dulcolax for the Bowel Preparation Prior Colonoscopy
- ClinicalTrials.gov ID
- NCT01984008
- Acronym / sponsor ID
- UIC-BKL-2013
- Conditions
- Bowel Preparation Before Colonoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 631 participants (actual)
- Lead sponsor
- Universal Integrated Corp.Industry (pharma, biotech, devices)
- Study start
- 23 Oct 2013 (actual)
- Primary completion
- 24 Mar 2014 (actual)
- Study completion
- 17 Jun 2014 (actual)
- First posted
- 14 Nov 2013 (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.
The primary objective of this study is to demonstrate that investigation medication (Bowklean) is not less effective than the active comparator (Klean-Prep with Dulcolax), with regards to the overall quality of bowel preparation in subjects undergoing colonoscopy. An additional objective of this study is to collect subject's response to the acceptability and tolerability about bowel preparation and safety information.
After bowel preparation, independent evaluator who is blinded to subject's treatment will evaluate the overall colon cleansing based on Aronchick and Ottawa scale. A total of 600 eligible subjects scheduled to a colonoscopy will be randomly assigned with equal allocation to 1 of 2 treatment groups: "Bowklean" or "Klean-Prep" with Dulcolax. Each subject's participation is expected to be maximally 4 weeks in study duration (up to 3-week screening period followed by one week post colonoscopy).
Detailed description
The objective of this study was to demonstrate that investigational medication (Bowklean) is not less effective than the active comparator (Klean-Prep with Dulcolax), with regards to the overall quality of bowel preparation in subjects undergoing colonoscopy. It was designed to measure the number of subjects whose colons are cleansed successfully.
The primary efficacy endpoint is the percentage of subjects that achieve excellent or good cleansing (success rate) in the Aronchick Scale.
The secondary efficacy variables include:
- Proportion of successes (excellent, good, or fair) by individual colon segment (ascending, transverse, descending), which are assessed with the Ottawa scale6.
- Mean bowel preparation score assessed with Ottawa Scale by adding points for the cleansing of three parts of colon and points for amount of fluid in the bowel.
- Percentage of subject's responses to the acceptability and tolerability
Safety was assessed at each clinic visit by evaluation of the following variables:
- Percentage of subjects occurred solicited event (nausea, vomiting, chest pain and dizziness) during the preparation.
- Percentage of subjects with treatment-emergent adverse events during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| picosulfate,MgO, citric acid, bowel preparation, powder | Experimental | Drug: Picosulfate sodium, magnesium oxide, citric acidcolonoscopy picosulfate,MgO, citric acid, bowel preparation, powder |
| polyethylene glycol, bisacodyl, | Active comparator | Drug: Picosulfate sodium, magnesium oxide, citric acidcolonoscopy polyethylene glycol,powder bisacodyl,tablet |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is 20 and 80 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 (13 listed)
- 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)
- Any prior colorectal surgery in the past 3 months, excluding appendectomy, hemorrhoid surgery or prior endoscopic procedures
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 |
|---|---|---|
| Picosulfate sodium, magnesium oxide, citric acid | Drug | picosulfate,MgO, citric acid, bowel preparation, powder, polyethylene glycol, bisacodyl, |
Primary outcome
The percentage of subjects that achieve excellent or good cleansing (success rate) in the Aronchick Scale.
Time frame: six months
1 secondary outcome
Proportion of successes (excellent, good, or fair) by individual colon segment (ascending, transverse, descending), which are assessed with the Ottawa scale.
Time frame: six months
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 30 Mar 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.
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 3 study testing Picosulfate sodium, magnesium oxide, citric acid in people with Bowel Preparation Before Colonoscopy, run by Universal Integrated Corp. 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 13 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 30 Mar 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 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 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 percentage of subjects that achieve excellent or good cleansing (success rate) in the Aronchick Scale. (time frame: six months). 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 30 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.