Primary Adrenal InsufficiencyPhase 2PHYSCANCT01450930
Pharmacokinetics of Hydrocortisone After Subcutaneous Administration in Chronic Adrenal Insufficiency
A Phase 2 study testing Hydrocortisone intramuscular first and Hydrocortisone subcutaneously first in people with Primary Adrenal Insufficiency, run by Bruno Allolio at 1 site in Germany.
Trial summary
Patients with chronic adrenal insufficiency need to adapt their hydrocortisone replacement dose in conditions of physical or psychological stress to prevent life threatening adrenal crisis. In cases of more severe impairment or unsecure gastrointestinal absorption (e.g. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Primary Adrenal Insufficiency
- What is being tested?
- Hydrocortisone intramuscular first and Hydrocortisone subcutaneously first
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2011to Jul 2012
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Primary adrenal insufficiency under standard glucocorticoid replacement therapy due to autoimmune adrenalitis or bilateral adrenalectomy (disease duration at least 12 months),
- age ≥ 18 years,
- Patient´s written informed consent,
- Ability to comply with the protocol procedures
Who cannot join
- Diabetes mellitus,
- Infectious disease with fever at time of investigation,
- Known intolerance to the study drug or constituents oft he study drug,
- Oral contraception,
- Known pregnancy or breast feeding,
- Renal failure (creatinine > 2.5 ULN)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept of Medicine I, Endocrinology and Diabetology, University Hospital Wuerzburg
Würzburg, 97080
About this study
Official title: Pharmacokinetics of Hydrocortisone After Subcutaneous Administration Compared With Intramuscular Injection in Chronic Adrenal Insufficiency
Patients with chronic adrenal insufficiency need to adapt their hydrocortisone replacement dose in conditions of physical or psychological stress to prevent life threatening adrenal crisis. In cases of more severe impairment or unsecure gastrointestinal absorption (e.g. gastroenteritis, severe infectious disease), parenteral administration of the hydrocortisone dose is crucial. The study is conducted to offer patients the possibility to perform hydrocortisone self administration in emergency situations in a way of administration which is easy to perform and accepted by the patient. Therefore, pharmacokinetics and safety of subcutaneous hydrocortisone administration will be studied and compared to intramuscular administration.
- Conditions
- Primary Adrenal Insufficiency
- Being tested
- Hydrocortisone intramuscular first, Hydrocortisone subcutaneously first
- Keywords
- Adrenal insufficiency, Addison's disease
- Medical subject headings
- Addison Disease, Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrocortisone intramuscular firstDrug
Also called 100 mg hydrocortisone (Pfizer®) in 2 ml solvent
Hydrocortisone intramuscular first
Hydrocortisone subcutaneously firstDrug
Also called 100 mg hydrocortisone (Pfizer®) in 2 ml solvent
Hydrocortisone subcutaneously first
| Study group | Role | What they receive |
|---|---|---|
| Hydrocortisone subcutaneously first | Active comparator | Hydrocortisone subcutaneously first Receives: Drug: Hydrocortisone subcutaneously first |
| Hydrocortisone intramuscular first | Active comparator | Hydrocortisone intramuscular first Receives: Drug: Hydrocortisone intramuscular first |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence Study
pharmakokinetic data (Cmax, time to Cmax, area under the curve of serum/salivary cortisol levels)
Measured: 4 hours
Secondary outcomes (1)
safety
number of adverse events after subcutaneous administration of hydrocortisone
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2012
- Study completionJul 2012
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 Primary 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bruno Allolio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bruno Allolio, University of Wuerzburg
- Investigators
- Stefanie Hahner, MD, Principal investigator, University Hospital Wuerzburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450930
- Sponsor's protocol ID
- PHYSCA-1
- Other IDs
- 2011-002687-25
- Acronym
- PHYSCA
- Status last verified
- Jul 2012
- First submitted
- 29 Sep 2011
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hahner S, Burger-Stritt S, Allolio B. Subcutaneous hydrocortisone administration for emergency use in adrenal insufficiency. Eur J Endocrinol. 2013 Jun 29;169(2):147-54. doi: 10.1530/EJE-12-1057. Print 2013 Aug.
PubMed 23672956
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Hydrocortisone After Subcutaneous Administration Compared With Intramuscular Injection in Chronic Adrenal Insufficiency
- ClinicalTrials.gov ID
- NCT01450930
- Acronym / sponsor ID
- PHYSCA / PHYSCA-1
- Conditions
- Primary Adrenal Insufficiency
- Keywords
- Adrenal insufficiency, Addison's disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Bruno AllolioUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 13 Oct 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.
Patients with chronic adrenal insufficiency need to adapt their hydrocortisone replacement dose in conditions of physical or psychological stress to prevent life threatening adrenal crisis. In cases of more severe impairment or unsecure gastrointestinal absorption (e.g. gastroenteritis, severe infectious disease), parenteral administration of the hydrocortisone dose is crucial. The study is conducted to offer patients the possibility to perform hydrocortisone self administration in emergency situations in a way of administration which is easy to perform and accepted by the patient. Therefore, pharmacokinetics and safety of subcutaneous hydrocortisone administration will be studied and compared to intramuscular administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrocortisone subcutaneously first | Active comparator | Drug: Hydrocortisone subcutaneously firstHydrocortisone subcutaneously first |
| Hydrocortisone intramuscular first | Active comparator | Drug: Hydrocortisone intramuscular firstHydrocortisone intramuscular first |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Primary adrenal insufficiency under standard glucocorticoid replacement therapy due to autoimmune adrenalitis or bilateral adrenalectomy (disease duration at least 12 months),
- age ≥ 18 years,
- Patient´s written informed consent,
- Ability to comply with the protocol procedures
Key exclusion criteria (6 listed)
- Diabetes mellitus,
- Infectious disease with fever at time of investigation,
- Known intolerance to the study drug or constituents oft he study drug,
- Oral contraception,
- Known pregnancy or breast feeding,
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 |
|---|---|---|
| Hydrocortisone intramuscular firstAlso: 100 mg hydrocortisone (Pfizer®) in 2 ml solventHydrocortisone intramuscular first | Drug | Hydrocortisone intramuscular first |
| Hydrocortisone subcutaneously firstAlso: 100 mg hydrocortisone (Pfizer®) in 2 ml solventHydrocortisone subcutaneously first | Drug | Hydrocortisone subcutaneously first |
Primary outcome
Bioequivalence Study
Time frame: 4 hours
pharmakokinetic data (Cmax, time to Cmax, area under the curve of serum/salivary cortisol levels)
1 secondary outcome
safety
Time frame: 3 days
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 1 Aug 2012.
- Derived from this study: PubMed 23672956Hahner S, Burger-Stritt S, Allolio B. Subcutaneous hydrocortisone administration for emergency use in adrenal insufficiency. Eur J Endocrinol. 2013 Jun 29;169(2):147-54. doi: 10.1530/EJE-12-1057. Print 2013 Aug.
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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.
Stefanie Hahner, MD principal investigator
University Hospital Wuerzburg, Germany
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 Hydrocortisone intramuscular first and Hydrocortisone subcutaneously first in people with Primary Adrenal Insufficiency, run by Bruno Allolio at 1 site in Germany.
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 6 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 1 Aug 2012. 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 Germany. 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?
Bioequivalence Study (time frame: 4 hours). 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 NCT01450930, 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 1 Aug 2012.