Bowel PreparationPhase 3LOWPEGNCT01568814
Low Volume PEG With Low Residue Test Meals Versus High Volume Split-dose PEG Bowel Preparation
A Phase 3 study testing Low volume PEG and high volume PEG in people with Bowel Preparation and Colonoscopy, run by Inje University at 1 site in South Korea.
Trial summary
Morning only low volume PEG with low reside meals may enhance patient tolerability and have similar bowel cleansing efficacy compared to standard method using high volume split-dose PEG with standard diet. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bowel Preparation, Colonoscopy
- What is being tested?
- Low volume PEG and high volume PEG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to Mar 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult outpatients and inpatients (18-85 years of age) who undergo colonoscopy for screening, cancer surveillance or with gastrointestinal symptoms, other symptoms
Who cannot join
- Age under 18 years
- Pregnancy
- Breast feeding
- Prior history of surgical large bowel resection
- Severe medical condition such as severe cardiac
- Hepatic, renal failure (creatinine ≥ 3.0mg/dL (normal 0.8-1.4))
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- Drug addiction or major psychiatric illness
- Suspected bowel obstruction or ileus
- Allergy to PEG
- 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 and Tolerability of Morning (AM) Only Low Volume (2L) PEG With Low Residue Test Meals Versus High Volume (4L) Split-dose (PM/AM) PEG Bowel Preparation With Standard Meals: A Prospective Randomized, Investigator Blinded Trial
Morning only low volume PEG with low reside meals may enhance patient tolerability and have similar bowel cleansing efficacy compared to standard method using high volume split-dose PEG with standard diet.
Read the detailed description
We aimed to evaluate the efficacy and tolerability of bowel preparation protocols with low volume PEG and low residue meals PEG compared to conventional high volume (4L) split-dose and standard diet.
Entry criteria: Entry criteria: Adult outpatients and inpatients (18-85 years of age) who undergo colonoscopy for screening, cancer surveillance or with gastrointestinal symptoms, other symptoms
Primary Outcome: Quality of bowel preparation (Ottawa scale) Secondary Outcome: Tolerability (preparation completion, side effect), acceptance, willingness
- Conditions
- Bowel Preparation, Colonoscopy
- Being tested
- Low volume PEG, high volume PEG
- Keywords
- colonoscopy, bowel preparation, polyethylene glycol, low residue meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low volume PEGDrug
low volume polyethylene glycol 2 liter one time
high volume PEGDrug
high volume polyethylene glycol 4 lilter split-dosing 2L/2L two times
| Study group | Role | What they receive |
|---|---|---|
| High volume PEG | Placebo comparator | Patients who are scheduled colonoscopy ingest high volume PEG(4L) for bowel preparation. Receives: Drug: high volume PEG |
| Low volume PEG with low residual meals | Active comparator | Patients who are scheduled colonoscopy ingest low volume PEG(2L) and have a prepackaged low residual meals for bowel preparation. Receives: Drug: Low volume PEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of bowel preparation
Quality of bowel preparation is assessed using Ottawa bowel preparation scale.
Measured: 2 months
Secondary outcomes (1)
Tolerability
Tolerability of bowel preparation regimen is assessed by patient questionnaire.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2012
- Study completionMar 2012
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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 188 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
- NCT01568814
- Sponsor's protocol ID
- 1.0-A2012
- Acronym
- LOWPEG
- Status last verified
- Jan 2012
- First submitted
- 29 Mar 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 and Tolerability of Morning (AM) Only Low Volume (2L) PEG With Low Residue Test Meals Versus High Volume (4L) Split-dose (PM/AM) PEG Bowel Preparation With Standard Meals: A Prospective Randomized, Investigator Blinded Trial
- ClinicalTrials.gov ID
- NCT01568814
- Acronym / sponsor ID
- LOWPEG / 1.0-A2012
- Conditions
- Bowel Preparation, Colonoscopy
- Keywords
- colonoscopy, bowel preparation, polyethylene glycol, low residue meal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 2 Apr 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.
Morning only low volume PEG with low reside meals may enhance patient tolerability and have similar bowel cleansing efficacy compared to standard method using high volume split-dose PEG with standard diet.
Detailed description
We aimed to evaluate the efficacy and tolerability of bowel preparation protocols with low volume PEG and low residue meals PEG compared to conventional high volume (4L) split-dose and standard diet.
Entry criteria: Entry criteria: Adult outpatients and inpatients (18-85 years of age) who undergo colonoscopy for screening, cancer surveillance or with gastrointestinal symptoms, other symptoms
Primary Outcome: Quality of bowel preparation (Ottawa scale) Secondary Outcome: Tolerability (preparation completion, side effect), acceptance, willingness
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High volume PEG | Placebo comparator | Drug: high volume PEGPatients who are scheduled colonoscopy ingest high volume PEG(4L) for bowel preparation. |
| Low volume PEG with low residual meals | Active comparator | Drug: Low volume PEGPatients who are scheduled colonoscopy ingest low volume PEG(2L) and have a prepackaged low residual meals for bowel preparation. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult outpatients and inpatients (18-85 years of age) who undergo colonoscopy for screening, cancer surveillance or with gastrointestinal symptoms, other symptoms
Key exclusion criteria (10 listed)
- Age under 18 years
- Pregnancy
- Breast feeding
- Prior history of surgical large bowel resection
- Severe medical condition such as severe cardiac
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 |
|---|---|---|
| Low volume PEGlow volume polyethylene glycol 2 liter one time | Drug | Low volume PEG with low residual meals |
| high volume PEGhigh volume polyethylene glycol 4 lilter split-dosing 2L/2L two times | Drug | High volume PEG |
Primary outcome
Quality of bowel preparation
Time frame: 2 months
Quality of bowel preparation is assessed using Ottawa bowel preparation scale.
1 secondary outcome
Tolerability
Time frame: 2 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.
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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 Low volume PEG and high volume PEG in people with Bowel Preparation and Colonoscopy, 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 10 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. Some participants in this study may receive a placebo. 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?
Quality of bowel preparation (time frame: 2 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.