Adrenal InsufficiencyNCT03013166
THIN Database Study: Resource Use and Outcomes in Patients With Adrenal Insufficiency Prescribed Hydrocortisone: Immediate, or Modified Release, or Prednisolone
An observational study of Adrenal Insufficiency, run by Shire.
Trial summary
To describe clinical outcomes and both primary and secondary care health care resource use in patients who have been prescribed either immediate-release (IR) hydrocortisone or modified-release (MR) hydrocortisone or prednisolone in the UK. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adrenal Insufficiency
- What is being tested?
- Corticosteroid medication
- Type of treatment
- Pill or oral medicine
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 1 Dec 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients in the THIN database who have a Read code for AI and have been prescribed either IR hydrocortisone or prednisolone or MR hydrocortisone (plenadren) between 2010 and the date of data extraction will be included
Who may be able to join
- Cohort 1 (IR hydrocortisone): All patients with a Read code for AI and a prescription of IR hydrocortisone between 2010 and data extraction but no prescription for MR hydrocortisone at any time during this period, and no earlier prescription for IR prednisolone during this period
- Cohort 2 (IR prednisolone): All patients with a Read code for AI and a prescription of IR prednisolone between 2010 and data extraction but no prescription for MR prednisolone at any time during this period, and no earlier prescription for IR prednisolone during this period
- Cohort 3a (MR Hydrocortisone): All patients with a Read code for AI and a prescription of MR hydrocortisone between 2010 and data extraction
- Cohort 3b (IR to MR hydrocortisone): A sub-set of patients from cohort 3a, who have switched from IR to MR hydrocortisone.
- A list of pre-defined READ codes will be used to identify all patients with primary or secondary AI or CAH in the THIN database.
Who cannot join
- 1)Patients who have not received a prescription of hydrocortisone or prednisolone in the past five years will be excluded as the aim of the study is to describe recent experience.
About this study
Official title: Resource Use and Clinical Outcomes in Patients With Adrenal Insufficiency Prescribed Either an Immediate Release or Modified Release Hydrocortisone Formulation or Prednisolone: A THIN (The Health Improvement Network) Database Study
To describe clinical outcomes and both primary and secondary care health care resource use in patients who have been prescribed either immediate-release (IR) hydrocortisone or modified-release (MR) hydrocortisone or prednisolone in the UK.
- Conditions
- Adrenal Insufficiency
- Being tested
- Corticosteroid medication
- Medical subject headings
- Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroid medicationOther
Patients will be grouped into Cohort 1 (IR hydrocortisone), cohort 2 (IR prednisolone), cohort 3 (MR hydrocortisone), or cohort 4 (IR to MR hydrocortisone) depending on which oral corticosteroid medications were received during the observation period.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | IR hydrocortisone Receives: Other: Corticosteroid medication | |
| Cohort 2 | IR prednisolone Receives: Other: Corticosteroid medication | |
| Cohort 3 | MR hydrocortisone Receives: Other: Corticosteroid medication | |
| Cohort 4 | IR to MR hydrocortisone Receives: Other: Corticosteroid medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary care resource use per year in all patients as measured by using number of primary care contacts
Measured: 4 months
Primary care resource use per year in all patients as measured by number of referrals to secondary care (by specialty)
Measured: 4 months
Primary care resource use per year in all patients as measured by number of sick notes issues
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study start1 Sep 2016
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal InsufficiencyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013166
- Sponsor's protocol ID
- SHP617-701
- Status last verified
- May 2021
- First submitted
- 20 Oct 2016
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resource Use and Clinical Outcomes in Patients With Adrenal Insufficiency Prescribed Either an Immediate Release or Modified Release Hydrocortisone Formulation or Prednisolone: A THIN (The Health Improvement Network) Database Study
- ClinicalTrials.gov ID
- NCT03013166
- Acronym / sponsor ID
- SHP617-701
- Conditions
- Adrenal Insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 6 Jan 2017 (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.
To describe clinical outcomes and both primary and secondary care health care resource use in patients who have been prescribed either immediate-release (IR) hydrocortisone or modified-release (MR) hydrocortisone or prednisolone in the UK.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: Corticosteroid medicationIR hydrocortisone |
| Cohort 2 | – | Other: Corticosteroid medicationIR prednisolone |
| Cohort 3 | – | Other: Corticosteroid medicationMR hydrocortisone |
| Cohort 4 | – | Other: Corticosteroid medicationIR to MR hydrocortisone |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients in the THIN database who have a Read code for AI and have been prescribed either IR hydrocortisone or prednisolone or MR hydrocortisone (plenadren) between 2010 and the date of data extraction will be included
Key inclusion criteria (5 listed)
- Cohort 1 (IR hydrocortisone): All patients with a Read code for AI and a prescription of IR hydrocortisone between 2010 and data extraction but no prescription for MR hydrocortisone at any time during this period, and no earlier prescription for IR prednisolone during this period
- Cohort 2 (IR prednisolone): All patients with a Read code for AI and a prescription of IR prednisolone between 2010 and data extraction but no prescription for MR prednisolone at any time during this period, and no earlier prescription for IR prednisolone during this period
- Cohort 3a (MR Hydrocortisone): All patients with a Read code for AI and a prescription of MR hydrocortisone between 2010 and data extraction
- Cohort 3b (IR to MR hydrocortisone): A sub-set of patients from cohort 3a, who have switched from IR to MR hydrocortisone.
- A list of pre-defined READ codes will be used to identify all patients with primary or secondary AI or CAH in the THIN database.
Key exclusion criteria (1 listed)
- 1)Patients who have not received a prescription of hydrocortisone or prednisolone in the past five years will be excluded as the aim of the study is to describe recent experience.
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 |
|---|---|---|
| Corticosteroid medicationPatients will be grouped into Cohort 1 (IR hydrocortisone), cohort 2 (IR prednisolone), cohort 3 (MR hydrocortisone), or cohort 4 (IR to MR hydrocortisone) depending on which oral corticosteroid medications were received during the observation period. | Other | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Primary care resource use per year in all patients as measured by using number of primary care contacts
Time frame: 4 months
Primary care resource use per year in all patients as measured by number of referrals to secondary care (by specialty)
Time frame: 4 months
Primary care resource use per year in all patients as measured by number of sick notes issues
Time frame: 4 months
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 3 Jun 2021.
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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.
Study Director study director
Takeda
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Insufficiency, run by Shire.
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 5 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 3 Jun 2021. 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?
Primary care resource use per year in all patients as measured by using number of primary care contacts (time frame: 4 months). The study lists 3 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 3 Jun 2021; AzTrials last refreshed its copy on 27 Oct 2026.