IntussusceptionNCT01479491
Study on the Incidence of Intussusception (IS) in Children Aged < 12 Months in Japan
An observational study of Intussusception, run by GlaxoSmithKline.
Trial summary
This study aims to analyse baseline data on IS in order to monitor the possibility of increased risk of IS in children aged <12 months after introduction of the Rotarix vaccination in Japan. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Intussusception
- What is being tested?
- Data collection
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Nov 2011
- Phase
- Observational
- 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 Up to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Children aged <12 months presenting with IS and covered by the JMDC-MDB database from January 2005 to April 2011.
Who may be able to join
- A male or female infant aged < 12 months at the time of IS diagnosis and affiliated to the JMDC-MDB database.
- An IS case should be identified as per the ICD-10 diagnostic code-K56.1 (any-field listed), examination codes, and procedural codes.
Who cannot join
- Not applicable
About this study
Official title: Observational Database Study on the Incidence of Intussusception in Children Aged < 12 Months in Japan
This study aims to analyse baseline data on IS in order to monitor the possibility of increased risk of IS in children aged <12 months after introduction of the Rotarix vaccination in Japan.
- Conditions
- Intussusception
- Being tested
- Data collection
- Keywords
- Japan, Retrospective, Observational, Epidemiological study, Children aged < 12 months, Intussusception
- Medical subject headings
- Intussusception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Data source will be the Japan Medical Data Centre Company Limited (JMDC) - JMDC Medical Data Bank (JMDC-MDB) database. Aggregated data (age in months and years and gender) for all subjects recorded in the database and subject-level data for IS cases will be extracted from the database. This database will be reviewed to extract data for the period between January 2005 and April 2011. Cases of IS will be identified using the International Classification of Diseases-10 (ICD-10) diagnostic codes, examination codes and procedural codes.
| Study group | Role | What they receive |
|---|---|---|
| Case Group | Children aged < 12 months presenting with IS and covered by the Japan Medical Data Centre Company Limited (JMDC), Tokyo referred to as the JMDC Medical Data Bank (JMDC-MDB). Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of IS in subjects aged < 12 months
Measured: Between January 2005 and April 2011 (6 years)
Occurrence of age-specific and gender-specific incidence of IS among subjects aged < 12 months in Japan
Measured: Between January 2005 and April 2011 (6 years)
Secondary outcomes (2)
Number of IS cases hospitalized more than once among subjects aged < 12 months.
Measured: Between January 2005 and April 2011 (6 years)
Occurrence of IS cases by calendar months and year among subjects aged < 12 months
Measured: Between January 2005 and April 2011 (6 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntussusceptionStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479491
- Sponsor's protocol ID
- 116259
- Status last verified
- Oct 2012
- First submitted
- 22 Nov 2011
- Last updated
- 22 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Database Study on the Incidence of Intussusception in Children Aged < 12 Months in Japan
- ClinicalTrials.gov ID
- NCT01479491
- Acronym / sponsor ID
- 116259
- Conditions
- Intussusception
- Keywords
- Japan, Retrospective, Observational, Epidemiological study, Children aged < 12 months, Intussusception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 24 Nov 2011 (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.
This study aims to analyse baseline data on IS in order to monitor the possibility of increased risk of IS in children aged <12 months after introduction of the Rotarix vaccination in Japan.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case Group | – | Other: Data collectionChildren aged < 12 months presenting with IS and covered by the Japan Medical Data Centre Company Limited (JMDC), Tokyo referred to as the JMDC Medical Data Bank (JMDC-MDB). |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged <12 months presenting with IS and covered by the JMDC-MDB database from January 2005 to April 2011.
Key inclusion criteria (2 listed)
- A male or female infant aged < 12 months at the time of IS diagnosis and affiliated to the JMDC-MDB database.
- An IS case should be identified as per the ICD-10 diagnostic code-K56.1 (any-field listed), examination codes, and procedural codes.
Key exclusion criteria (1 listed)
- Not applicable
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 |
|---|---|---|
| Data collectionData source will be the Japan Medical Data Centre Company Limited (JMDC) - JMDC Medical Data Bank (JMDC-MDB) database. Aggregated data (age in months and years and gender) for all subjects recorded in the database and subject-level data for IS cases will be extracted from the database. This database will be reviewed to extract data for the period between January 2005 and April 2011. Cases of IS will be identified using the International Classification of Diseases-10 (ICD-10) diagnostic codes, examination codes and procedural codes. | Other | Case Group |
Primary outcome
Occurrence of IS in subjects aged < 12 months
Time frame: Between January 2005 and April 2011 (6 years)
Occurrence of age-specific and gender-specific incidence of IS among subjects aged < 12 months in Japan
Time frame: Between January 2005 and April 2011 (6 years)
2 secondary outcomes
Number of IS cases hospitalized more than once among subjects aged < 12 months.
Time frame: Between January 2005 and April 2011 (6 years)
Occurrence of IS cases by calendar months and year among subjects aged < 12 months
Time frame: Between January 2005 and April 2011 (6 years)
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 22 Oct 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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Intussusception, run by GlaxoSmithKline.
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 1 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 22 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Occurrence of IS in subjects aged < 12 months (time frame: Between January 2005 and April 2011 (6 years)). The study lists 2 primary outcomes in all. 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 22 Oct 2012.