ColonoscopyPhase 3PSPEGNCT01513096
Efficacy of Prokinetics With Split Dose of PEG in Morning Colonoscopic Bowel Preparation
A Phase 3 study testing itopride in people with Colonoscopy and Bowel Preparation, run by Inje University at 1 site in South Korea.
Trial summary
In bowel preparation using split dose PEG, various adjuncts to colonic cleansing were proposed to improve colonic preparation cleansing. Prokinetics, as an adjunct, was included in a few studies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonoscopy, Bowel Preparation
- What is being tested?
- itopride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2011to Jan 2012
- 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
- Patient who are scheduled for colonoscopy
Who cannot join
- pregnancy,
- breast feeding,
- known or suspected bowel obstruction, and
- known allergy to PEG or Itopride ,
- presence of severe illness(renal failure, congestive heart failure, liver failure,), and
- refusal of consent to participate in the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Haeundae Paik Hospital, Inje University School of Medicine
Busan, 612-030
About this study
Official title: Efficacy of Prokinetics With Split Dose of PEG in Morning Colonoscopic Bowel Preparation: A Randomized, Controlled Trial
In bowel preparation using split dose PEG, various adjuncts to colonic cleansing were proposed to improve colonic preparation cleansing. Prokinetics, as an adjunct, was included in a few studies. The investigators study was to show that sufficient dosage of prokinetics added to split dose of PEG improves the state of bowel preparation.
Read the detailed description
This was a randomized, prospective, endoscopist-blinded clinical trial in which the efficacy of prokinetics coadministrated with split dose PEG on the bowel cleansing was inspected.
Endoscopists, who were blinded to the study group of the patient, immediately completed the Ottawa scale and the fluidity scale after procedure
- Conditions
- Colonoscopy, Bowel Preparation
- Being tested
- itopride
- Keywords
- colonoscopy, bowel preparation, PEG, Prokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
itoprideDrug
itopride, 10mg, twice per day, for 1 day
| Study group | Role | What they receive |
|---|---|---|
| Split-dose PEG | No intervention | Bowel preparation using split dose PEG without prokinetics |
| Split dose PEG with prokinetics | Active comparator | Bowel preparation using split-dose PEG with prokinetics Receives: Drug: itopride |
What is being measured
The primary outcome is the main question the study is designed to answer.
bowel cleaning quality according to Ottawa scale scores
Measured: 3 months
Secondary outcomes (1)
procedure time and polyp detection rate
cecal intubation time, polyp detection rate, degree of patient discomfort
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Hee Seo, MD, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513096
- Sponsor's protocol ID
- GI-201201
- Acronym
- PSPEG
- Status last verified
- Jan 2012
- First submitted
- 16 Jan 2012
- Last updated
- 3 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Prokinetics With Split Dose of PEG in Morning Colonoscopic Bowel Preparation: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01513096
- Acronym / sponsor ID
- PSPEG / GI-201201
- Conditions
- Colonoscopy, Bowel Preparation
- Keywords
- colonoscopy, bowel preparation, PEG, Prokinetics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 20 Jan 2012 (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.
In bowel preparation using split dose PEG, various adjuncts to colonic cleansing were proposed to improve colonic preparation cleansing. Prokinetics, as an adjunct, was included in a few studies. The investigators study was to show that sufficient dosage of prokinetics added to split dose of PEG improves the state of bowel preparation.
Detailed description
This was a randomized, prospective, endoscopist-blinded clinical trial in which the efficacy of prokinetics coadministrated with split dose PEG on the bowel cleansing was inspected.
Endoscopists, who were blinded to the study group of the patient, immediately completed the Ottawa scale and the fluidity scale after procedure
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Split-dose PEG | No intervention | –Bowel preparation using split dose PEG without prokinetics |
| Split dose PEG with prokinetics | Active comparator | Drug: itoprideBowel preparation using split-dose PEG with prokinetics |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient who are scheduled for colonoscopy
Key exclusion criteria (6 listed)
- pregnancy,
- breast feeding,
- known or suspected bowel obstruction, and
- known allergy to PEG or Itopride ,
- presence of severe illness(renal failure, congestive heart failure, liver failure,), and
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 |
|---|---|---|
| itoprideitopride, 10mg, twice per day, for 1 day | Drug | Split dose PEG with prokinetics |
Primary outcome
bowel cleaning quality according to Ottawa scale scores
Time frame: 3 months
1 secondary outcome
procedure time and polyp detection rate
Time frame: 3 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 3 Apr 2012.
Related trials for Colonoscopy
Not yet recruiting
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Colonoscopy
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Not yet recruiting
HFNC vs Conventional Oxygen During Gastrocolonoscopy in Elderly Patients
Hypoxemia, Eldery People
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
The Effect of Audio-visual Aids on Bowel Cleanliness, Audiovisual Aids
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 itopride in people with Colonoscopy and Bowel Preparation, run by Inje University 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 1 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: finished, as of the sponsor's last update on 3 Apr 2012. 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?
bowel cleaning quality according to Ottawa scale scores (time frame: 3 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 3 Apr 2012.