ColonoscopyPhase 3SP2HPNCT01685970
Comparison of Same-day 2 Sachets Picosulfate Versus High Volume PEG for Afternoon Colonoscopy
A Phase 3 study testing High volume split-dose PEG and 2 sachets of picosulfate in people with Colonoscopy, run by Inje University at 1 site in South Korea.
Trial summary
Comparison of using the same-day 2 sachets picosulfate versus high volume PEG bowel preparation for afternoon colonoscopy Morning only same-day 2 sachets picosulfate may enhance patient tolerability and have similar bowel cleansing efficacy compared to standard method using high volume split-dose PEG. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- High volume split-dose PEG and 2 sachets of picosulfate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to Nov 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
- Adult outpatients who undergo afternoon colonoscopy for screening, surveillance or with symptoms
Who cannot join
- pregnancy,
- breast feeding,
- prior history of surgical large bowel resection,
- severe medical condition such as severe cardiac,
- hepatic, or
- renal failure (creatinine ≥ 3.0 mg/dL (normal 0.8-1.4 mg/dL)),
Show all 10Show fewer
- significant gastric paresis or gastric outlet obstruction or ileus,
- known or suspected bowel obstruction or perforation,
- drug addiction or major psychiatric illness,
- allergy to PEG and refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Haeundae Paik Hospital, Inje University College of Medicine
Busan, 612-030
Eun Hee Seo, MD, 82-51-797-0220 ext. 0220, arate98@naver.com
Tae Oh Kim, Ph D, 52-51-797-0658 ext. 0658, kto0440@paik.ac.kr
About this study
Official title: Comparison of Using the Same-day 2 Sachets Picosulfate Versus High Volume PEG Bowel Preparation for Afternoon Colonoscopy
Comparison of using the same-day 2 sachets picosulfate versus high volume PEG bowel preparation for afternoon colonoscopy Morning only same-day 2 sachets picosulfate may enhance patient tolerability and have similar bowel cleansing efficacy compared to standard method using high volume split-dose PEG.
The investigators aimed to evaluate the efficacy and tolerability of bowel preparation protocols with same-day 2 sachets picosulfate compared to conventional high volume (4L) split-dose for afternoon colonoscopy.
Read the detailed description
Split-dose PEG (4L) regimens is a standard regimen for bowel preparation because it has better preparation quality and tolerability than single dose 4L PEG regimens. However, although patients drink each 2L separately, the total volume of 4 L PEG is still quite burdensome volume to ingest. In addition, in split dose method, night dose of day before the procedure make patient to suffer from sleep disturbance because of frequent diarrhea and abdominal discomfort.
The investigators aimed to evaluate the efficacy and tolerability of bowel preparation protocols with same-day 2 sachets picosulfate compared to conventional high volume (4L) split-dose for afternoon colonoscopy.
- Conditions
- Colonoscopy
- Being tested
- High volume split-dose PEG, 2 sachets of picosulfate
- Keywords
- Bowel preparation, colonoscopy, polyethylene glycol, picosulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High volume split-dose PEGDrug
Also called Polyethylene glycol(Colyte)
High volume split-dose PEG 2L/2L 2 times before the day and at the day of colonoscopy
2 sachets of picosulfateDrug
Also called sodium picosulfate
2 sachets of picosulfate 2 times for bowel preparation at the day of colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| High volume Split-dose PEG | Placebo comparator | Patients who are scheduled afternoon colonoscopy ingest high volume split-dose PEG for bowel preparation Receives: Drug: High volume split-dose PEG |
| 2 sachets of picosulfate | Active comparator | Patients who are scheduled afternoon colonoscopy ingest 2 sachets of picosulfate at the day of colonoscopy. Receives: Drug: 2 sachets of picosulfate |
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 using Ottawa bowel preparation scale
Measured: 3 months
Secondary outcomes (1)
Tolerability
Tolerability of bowel preparation regimen is assessed by patient questionnaire.
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 posted17 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2012 (estimated)
- Study completionNov 2012 (estimated)
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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Hee Seo, MD, Inje University
- Investigators
- Tae Oh Kim, Ph D, Study director, Haeundae Paik Hospital, Inje University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685970
- Sponsor's protocol ID
- HGI-2012-09
- Acronym
- SP2HP
- Status last verified
- Sep 2012
- First submitted
- 12 Sep 2012
- Last updated
- 17 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Using the Same-day 2 Sachets Picosulfate Versus High Volume PEG Bowel Preparation for Afternoon Colonoscopy
- ClinicalTrials.gov ID
- NCT01685970
- Acronym / sponsor ID
- SP2HP / HGI-2012-09
- Conditions
- Colonoscopy
- Keywords
- Bowel preparation, colonoscopy, polyethylene glycol, picosulfate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 17 Sep 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.
Comparison of using the same-day 2 sachets picosulfate versus high volume PEG bowel preparation for afternoon colonoscopy Morning only same-day 2 sachets picosulfate may enhance patient tolerability and have similar bowel cleansing efficacy compared to standard method using high volume split-dose PEG.
The investigators aimed to evaluate the efficacy and tolerability of bowel preparation protocols with same-day 2 sachets picosulfate compared to conventional high volume (4L) split-dose for afternoon colonoscopy.
Detailed description
Split-dose PEG (4L) regimens is a standard regimen for bowel preparation because it has better preparation quality and tolerability than single dose 4L PEG regimens. However, although patients drink each 2L separately, the total volume of 4 L PEG is still quite burdensome volume to ingest. In addition, in split dose method, night dose of day before the procedure make patient to suffer from sleep disturbance because of frequent diarrhea and abdominal discomfort.
The investigators aimed to evaluate the efficacy and tolerability of bowel preparation protocols with same-day 2 sachets picosulfate compared to conventional high volume (4L) split-dose for afternoon colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High volume Split-dose PEG | Placebo comparator | Drug: High volume split-dose PEGPatients who are scheduled afternoon colonoscopy ingest high volume split-dose PEG for bowel preparation |
| 2 sachets of picosulfate | Active comparator | Drug: 2 sachets of picosulfatePatients who are scheduled afternoon colonoscopy ingest 2 sachets of picosulfate at the day of colonoscopy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult outpatients who undergo afternoon colonoscopy for screening, surveillance or with symptoms
Key exclusion criteria (10 listed)
- pregnancy,
- breast feeding,
- prior history of surgical large bowel resection,
- severe medical condition such as severe cardiac,
- hepatic, or
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 |
|---|---|---|
| High volume split-dose PEGAlso: Polyethylene glycol(Colyte)High volume split-dose PEG 2L/2L 2 times before the day and at the day of colonoscopy | Drug | High volume Split-dose PEG |
| 2 sachets of picosulfateAlso: sodium picosulfate2 sachets of picosulfate 2 times for bowel preparation at the day of colonoscopy | Drug | 2 sachets of picosulfate |
Primary outcome
Quality of bowel preparation
Time frame: 3 months
Quality of bowel preparation using Ottawa bowel preparation scale
1 secondary outcome
Tolerability
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 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.
Tae Oh Kim, Ph D study director
Haeundae Paik Hospital, Inje University College of Medicine
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 High volume split-dose PEG and 2 sachets of picosulfate in people with 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: status not confirmed, as of the sponsor's last update on 17 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tae Oh Kim, Ph D. (82-51-797-0658 ext. 0658, kto0440@paik.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of bowel preparation (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 17 Sep 2012.