Asymptomatic Subjects With Atopy and Elevated Serum IgEPhase 2NCT01106703
The Effects of PG102, a Water Soluble Extract From Actinidia Arguta, on Serum Total IgE Levels
A Phase 2 study testing PG102, a water soluble extract from Actinidia arguta in people with Asymptomatic Subjects With Atopy and Elevated Serum IgE, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
The aim of this study was to evaluate the efficacy of PG102 at lowering levels of total IgE in asymptomatic subjects with atopy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asymptomatic Subjects With Atopy and Elevated Serum IgE
- What is being tested?
- PG102, a water soluble extract from Actinidia arguta
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Dec 2006to Apr 2008
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subjects who have atopy but no allergy-related symptoms
- subjects with total IgE levels of 300IU/ml or more
- acquisition of written informed consent prior to commencement of study
- no serious clinical symptoms and normal laboratory test results; in case of abnormal finding, subjects whose conditions are not deemed severe from the judgement of investigators
Who cannot join
- individuals with normal levels of total serum IgE
- ue of one or more allergic drugs
- serious clinical conditions (such as malignancies, severe cardiovascular disease etc.)
- serious mental disorder
- pregnant woman or woman of childbearing potential within 3 months
- subjects who participated in other clinical trials in the past 6months
Show all 9Show fewer
- individuals who have a plan to participate in another clinical trials during this trial
- subjects with a history of kiwi allergy
- subjects whose conditions are inappropriate by investigators
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Soeul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
Seoul National University Hospital
Seoul
About this study
Official title: The Effects of PG102 on Allergy-related Risk Factors: A Randomized, Double Blind, Placebo Controlled Study
The aim of this study was to evaluate the efficacy of PG102 at lowering levels of total IgE in asymptomatic subjects with atopy.
- Being tested
- PG102, a water soluble extract from Actinidia arguta, placebo
- Keywords
- atopy, IgE
- Medical subject headings
- Epilepsy, Idiopathic Generalized
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG102, a water soluble extract from Actinidia argutaDietary supplement
PG102 two tables(Actinidia arguta extract:Microcrystalline cellulose(1:1)mixed powder 1120mg) twice a day for 8weeks
placeboOther
placebo two tables(equivalent dose of Microcrystalline cellulose) twice a day for 8weeks
| Study group | Role | What they receive |
|---|---|---|
| PG102 group | Experimental | Not described Receives: Dietary Supplement: PG102, a water soluble extract from Actinidia arguta |
| placebo group | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum total IgE level
Measured: 8weeks
Secondary outcomes (1)
serum level of allergy-related factors, such as eosinophilic cation protein(ECP), eotaxin, thymus, and activation-regulated chemokine (TARC), IL-4, IL-5, and IL-13, skin test(atopy score), and adverse reactions
Measured: 8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startDec 2006
- Primary completionMar 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic Subjects With Atopy and Elevated Serum IgEStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Investigators
- Kyung-Up Min, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106703
- Sponsor's protocol ID
- A060655
- Status last verified
- Jul 2010
- First submitted
- 19 Apr 2010
- Last updated
- 27 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of PG102 on Allergy-related Risk Factors: A Randomized, Double Blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT01106703
- Acronym / sponsor ID
- A060655
- Keywords
- atopy, IgE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Study start
- Dec 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 20 Apr 2010 (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 aim of this study was to evaluate the efficacy of PG102 at lowering levels of total IgE in asymptomatic subjects with atopy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PG102 group | Experimental | Dietary Supplement: PG102, a water soluble extract from Actinidia arguta |
| placebo group | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- subjects who have atopy but no allergy-related symptoms
- subjects with total IgE levels of 300IU/ml or more
- acquisition of written informed consent prior to commencement of study
- no serious clinical symptoms and normal laboratory test results; in case of abnormal finding, subjects whose conditions are not deemed severe from the judgement of investigators
Key exclusion criteria (9 listed)
- individuals with normal levels of total serum IgE
- ue of one or more allergic drugs
- serious clinical conditions (such as malignancies, severe cardiovascular disease etc.)
- serious mental disorder
- pregnant woman or woman of childbearing potential within 3 months
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 |
|---|---|---|
| PG102, a water soluble extract from Actinidia argutaPG102 two tables(Actinidia arguta extract:Microcrystalline cellulose(1:1)mixed powder 1120mg) twice a day for 8weeks | Dietary supplement | PG102 group |
| placeboplacebo two tables(equivalent dose of Microcrystalline cellulose) twice a day for 8weeks | Other | placebo group |
Primary outcome
serum total IgE level
Time frame: 8weeks
1 secondary outcome
serum level of allergy-related factors, such as eosinophilic cation protein(ECP), eotaxin, thymus, and activation-regulated chemokine (TARC), IL-4, IL-5, and IL-13, skin test(atopy score), and adverse reactions
Time frame: 8weeks
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 27 Jul 2010.
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.
Kyung-Up Min, M.D., Ph.D. principal investigator
Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PG102, a water soluble extract from Actinidia arguta in people with Asymptomatic Subjects With Atopy and Elevated Serum IgE, run by Seoul National University Hospital at 2 sites 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 4 inclusion and 9 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 27 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
serum total IgE level (time frame: 8weeks). 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 27 Jul 2010.