Esophageal DiseasesPhase 4NCT02002078
Caustic Esophageal Burns in Children and High Doses of Methylprednisolone
A Phase 4 study testing methylprednisolon in people with Esophageal Diseases, run by Sisli Hamidiye Etfal Training and Research Hospital.
Trial summary
Corrosive substance ingestion in childhood is a public health issue in developing countries and several management protocols were proposed to prevent esophageal strictures. The role of corticosteroids in preventing corrosive-induced strictures is controversial. Read more about this study
- Who is it for?
- Ages 12 months to 17 years
- Conditions the study is for
- Esophageal Diseases
- What is being tested?
- methylprednisolon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to Dec 2008
- Phase
- Phase 4
- 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 12 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -Corrosive substance ingested children with grade IIb esophageal burn
Who cannot join
- Caustic substance ingested chldren grade I, IIa and grade III esophageal burns
- Caustic subtance ingested children with signs of perforation, mediastinitis, peritonitis, sespis
- Caustic substance ingested children with any chronic disease
About this study
Official title: High Doses of Methylprednisolone in the Management of Caustic Esophageal Burns in Children
Corrosive substance ingestion in childhood is a public health issue in developing countries and several management protocols were proposed to prevent esophageal strictures. The role of corticosteroids in preventing corrosive-induced strictures is controversial. The investigators' aim is to study the influence of high doses of corticosteroids to prevent esophageal strictures.
- Conditions
- Esophageal Diseases
- Being tested
- methylprednisolon
- Keywords
- caustic, corticosteroid therapy, stricture, children
- Medical subject headings
- Esophageal Diseases, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylprednisolonDrug
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone, caustic burns | No intervention | Not described Receives: Drug: methylprednisolon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of stricture development in children with caustic esophageal burns after high doses of methylprednisolone
stricture development was evaluated with endoscopic examination and upper gastrointestinal system series with barium swallow
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startFeb 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal DiseasesStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Usta, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002078
- Sponsor's protocol ID
- ClinicalTrials.gov
- Status last verified
- Nov 2013
- First submitted
- 22 Nov 2013
- Last updated
- 5 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Usta M, Erkan T, Cokugras FC, Urganci N, Onal Z, Gulcan M, Kutlu T. High doses of methylprednisolone in the management of caustic esophageal burns. Pediatrics. 2014 Jun;133(6):E1518-24. doi: 10.1542/peds.2013-3331.
PubMed 24864182
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Doses of Methylprednisolone in the Management of Caustic Esophageal Burns in Children
- ClinicalTrials.gov ID
- NCT02002078
- Acronym / sponsor ID
- ClinicalTrials.gov
- Conditions
- Esophageal Diseases
- Keywords
- caustic, corticosteroid therapy, stricture, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 5 Dec 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.
Corrosive substance ingestion in childhood is a public health issue in developing countries and several management protocols were proposed to prevent esophageal strictures. The role of corticosteroids in preventing corrosive-induced strictures is controversial. The investigators' aim is to study the influence of high doses of corticosteroids to prevent esophageal strictures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone, caustic burns | No intervention | Drug: methylprednisolon |
Who may qualify
- Ages
- 12 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- -Corrosive substance ingested children with grade IIb esophageal burn
Key exclusion criteria (3 listed)
- Caustic substance ingested chldren grade I, IIa and grade III esophageal burns
- Caustic subtance ingested children with signs of perforation, mediastinitis, peritonitis, sespis
- Caustic substance ingested children with any chronic disease
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 |
|---|---|---|
| methylprednisolon | Drug | Methylprednisolone, caustic burns |
Primary outcome
Evaluation of stricture development in children with caustic esophageal burns after high doses of methylprednisolone
Time frame: three years
stricture development was evaluated with endoscopic examination and upper gastrointestinal system series with barium swallow
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 5 Dec 2013.
- Derived from this study: PubMed 24864182Usta M, Erkan T, Cokugras FC, Urganci N, Onal Z, Gulcan M, Kutlu T. High doses of methylprednisolone in the management of caustic esophageal burns. Pediatrics. 2014 Jun;133(6):E1518-24. doi: 10.1542/peds.2013-3331.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing methylprednisolon in people with Esophageal Diseases, run by Sisli Hamidiye Etfal Training and Research Hospital.
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 3 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 5 Dec 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Evaluation of stricture development in children with caustic esophageal burns after high doses of methylprednisolone (time frame: three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02002078, which also lists 1 linked publication.
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 5 Dec 2013.