HealthyPhase 2NCT01919255
Evaluation of PICOLIGHT Plus COOLPREP, PICOLIGHT Plus CLICOLON for Bowel Preparation
A Phase 2 study testing Picolight + Coolprep and Picolight + Clicolon in people with Healthy, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
The purpose of this study to bowel cleansing evaluation of mixed two other type bowel preparation drug(PICOLIGHT plus COOLPREP, PICOLIGHT plus CLICOLON). Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Picolight + Coolprep and Picolight + Clicolon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2013to Oct 2014
- Phase
- Phase 2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20-65 years of age
- Elective colonoscopy of outpatients(consent to the study)
Who cannot join
- Active enteritis, enteric bleeding, obstruction
- Pregnant or lactating women
- Severe liver or renal insufficiency
- Allergic to any preparation components
- History of heart disease (ischemic heart disease, congestive heart failure, arrythmia)
- History of colorectal surgery
Show all 17Show fewer
- History abdominal surgery within 6 month
- Toxic colitis or megacolon
- Nausea or vomiting
- Status emergent abdominal surgery (ex. acute appendicitis)
- Uncontrolled clinically significant pre-existing electrolyte disturbance
- Dehydration
- Phenylketonuria
- Glucose-6-phosphate dehydrogenase deficiency
- Ileus
- Suspicious hyperphosphatemia
- Acute phosphate nephropathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of PICOLIGHT Plus COOLPREP, PICOLIGHT Plus CLICOLON for Bowel Preparation (The Phase II Prospective Randomized Clinical Trial)
The purpose of this study to bowel cleansing evaluation of mixed two other type bowel preparation drug(PICOLIGHT plus COOLPREP, PICOLIGHT plus CLICOLON).
Read the detailed description
To evaluate mixed-drug bowel preparation methods for decreasing side effect and increasing compliance
Picolight + Coolprep [Day-Prior] Picolight + Clicolon [Day-Prior] Picolight + Coolprep [Split-Dose] Picolight + Clicolon [Split-Dose]
- Conditions
- Healthy
- Being tested
- Picolight + Coolprep, Picolight + Clicolon
- Keywords
- Colonoscopy, Bowel preparation, Picolight, Clicolon, Coolprep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Picolight + CoolprepDrug
Also called Picolight(Citric acid, Magnesium Oxide, Sodium picosulfate), Coolprep(PEG 3350 + EL, Ascobic acid, Sodium sulfate)
Picolight (1p/250cc, 5PM) + Coolprep (500cc x 2, 8PM)[Day-Prior] Picolight (1p/250cc, 7PM) + Coolprep (500cc x 2, 5AM)[Split-Dose]
Picolight + ClicolonDrug
Also called Picolight(Citric acid, Magnesium Oxide, Sodium picosulfate), Clicolon(Sodium phosphate)
Picolight (1p/250cc, 5PM) + Clicolon (4T x 4, 8PM) [Day-Prior] Picolight (1p/250cc, 7PM) + Clicolon (4T x 4, 5AM)[Split-Dose]
| Study group | Role | What they receive |
|---|---|---|
| Picolight + Coolprep (Day-Prior) | Active comparator | Picolight (1p/250cc, 5PM) + Coolprep (500cc x 2, 8PM)[Day-Prior] Receives: Drug: Picolight + Coolprep |
| Picolight + Clicolon (Day-Prior) | Active comparator | Picolight (1p/250cc, 5PM) + Clicolon (4T x 4, 8PM) [Day-Prior] Receives: Drug: Picolight + Clicolon |
| Picolight + Coolprep (Split-Dose) | Active comparator | Picolight (1p/250cc, 7PM) + Coolprep (500cc x 2, 5AM)[Split-Dose] Receives: Drug: Picolight + Coolprep |
| Picolight + Clicolon (Split-Dose) | Active comparator | Picolight (1p/250cc, 7PM) + Clicolon (4T x 4, 5AM)[Split-Dose] Receives: Drug: Picolight + Clicolon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel preparation quality
Aronchick bowel preparation score;
Excellent: small volume of clear liquid or greater than 95% of surface seen
Good: large volume of clear liquid 5% to 25% of the surface but greater than 90% of surface seen
Fair: some semi-solid stool that could be suctioned or washed away, but greater than 90% of surface seen
Poor: semi-solid stool that could not be suctioned or washed away and less than 90% of surface seen
Inadequate: re-preparation needed
(* 'success' of bowel preparation is defined as Aronchick's 'Excellent' or 'Good'.)
Measured: the day of colonoscopy
Secondary outcomes (1)
Patient tolerance
Patient's tolerance;
1= "none"; 2= "mild"; 3= "bothersome"; 4= "distressing"; 5= "severely distressing"
Measured: the day of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 2
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dae Kyung Sohn, National Cancer Center, Korea
- Investigators
- Dae Kyung Sohn, Principal investigator, NCC,Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919255
- Sponsor's protocol ID
- NCC-CAN-001
- Status last verified
- Mar 2015
- First submitted
- 3 Aug 2013
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of PICOLIGHT Plus COOLPREP, PICOLIGHT Plus CLICOLON for Bowel Preparation (The Phase II Prospective Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT01919255
- Acronym / sponsor ID
- NCC-CAN-001
- Conditions
- Healthy
- Keywords
- Colonoscopy, Bowel preparation, Picolight, Clicolon, Coolprep
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Aug 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 8 Aug 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 purpose of this study to bowel cleansing evaluation of mixed two other type bowel preparation drug(PICOLIGHT plus COOLPREP, PICOLIGHT plus CLICOLON).
Detailed description
To evaluate mixed-drug bowel preparation methods for decreasing side effect and increasing compliance
Picolight + Coolprep [Day-Prior] Picolight + Clicolon [Day-Prior] Picolight + Coolprep [Split-Dose] Picolight + Clicolon [Split-Dose]
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Picolight + Coolprep (Day-Prior) | Active comparator | Drug: Picolight + CoolprepPicolight (1p/250cc, 5PM) + Coolprep (500cc x 2, 8PM)[Day-Prior] |
| Picolight + Clicolon (Day-Prior) | Active comparator | Drug: Picolight + ClicolonPicolight (1p/250cc, 5PM) + Clicolon (4T x 4, 8PM) [Day-Prior] |
| Picolight + Coolprep (Split-Dose) | Active comparator | Drug: Picolight + CoolprepPicolight (1p/250cc, 7PM) + Coolprep (500cc x 2, 5AM)[Split-Dose] |
| Picolight + Clicolon (Split-Dose) | Active comparator | Drug: Picolight + ClicolonPicolight (1p/250cc, 7PM) + Clicolon (4T x 4, 5AM)[Split-Dose] |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 20-65 years of age
- Elective colonoscopy of outpatients(consent to the study)
Key exclusion criteria (17 listed)
- Active enteritis, enteric bleeding, obstruction
- Pregnant or lactating women
- Severe liver or renal insufficiency
- Allergic to any preparation components
- History of heart disease (ischemic heart disease, congestive heart failure, arrythmia)
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 |
|---|---|---|
| Picolight + CoolprepAlso: Picolight(Citric acid, Magnesium Oxide, Sodium picosulfate), Coolprep(PEG 3350 + EL, Ascobic acid, Sodium sulfate)Picolight (1p/250cc, 5PM) + Coolprep (500cc x 2, 8PM)[Day-Prior] Picolight (1p/250cc, 7PM) + Coolprep (500cc x 2, 5AM)[Split-Dose] | Drug | Picolight + Coolprep (Day-Prior), Picolight + Coolprep (Split-Dose) |
| Picolight + ClicolonAlso: Picolight(Citric acid, Magnesium Oxide, Sodium picosulfate), Clicolon(Sodium phosphate)Picolight (1p/250cc, 5PM) + Clicolon (4T x 4, 8PM) [Day-Prior] Picolight (1p/250cc, 7PM) + Clicolon (4T x 4, 5AM)[Split-Dose] | Drug | Picolight + Clicolon (Day-Prior), Picolight + Clicolon (Split-Dose) |
Primary outcome
Bowel preparation quality
Time frame: the day of colonoscopy
Aronchick bowel preparation score; Excellent: small volume of clear liquid or greater than 95% of surface seen Good: large volume of clear liquid 5% to 25% of the surface but greater than 90% of surface seen Fair: some semi-solid stool that could be suctioned or washed away, but greater than 90% of surface seen Poor: semi-solid stool that could not be suctioned or washed away and less than 90% of surface seen Inadequate: re-preparation needed (* 'success' of bowel preparation is defined as Aronchick's 'Excellent' or 'Good'.)
1 secondary outcome
Patient tolerance
Time frame: the day of 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 26 Mar 2015.
Related trials for Healthy
Recruiting
Trained vs. Untrained: Lower Extremity Pressure Changes
Trained Athletes, Untrained
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1
A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response
Healthy
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.
Dae Kyung Sohn principal investigator
NCC,Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Picolight + Coolprep and Picolight + Clicolon in people with Healthy, run by National Cancer Center, Korea 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 2 inclusion and 17 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 26 Mar 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 preparation quality (time frame: the day of 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 26 Mar 2015.