Rheumatic DiseasesPhase 4NCT03558971
Patient Self-administration of Cortisol for Cortisol-responding Disorders in Men and Women Over the Age of 17
A Phase 4 study testing Cortisol in people with Rheumatic Diseases, run by Helen Foundation at 1 site in United States.
Trial summary
Participants diagnosed as having fibromyalgia, osteoarthritis, and rheumatoid arthritis are to be brought to a minimum symptom state using a 3-week period during which they are to ingest modest doses of cortisol tablets with weekly lowered tapered doses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatic Diseases
- What is being tested?
- Cortisol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,430 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2000to 31 Dec 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnoses of fibromyalgia, osteoarthritis, or rheumatoid arthritis -
Who cannot join
- Congestive heart failure, stomach ulceration, unstable diabetes, and bipolar disorder
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Helen Foundation Clinic
Apache Junction, Arizona, 85120
About this study
Official title: Patient Self-administration of Cortisol for Cortisol-responding Disorders in Men and Women Over the Age of 17, Demonstration of Double-blind Trial Results
Participants diagnosed as having fibromyalgia, osteoarthritis, and rheumatoid arthritis are to be brought to a minimum symptom state using a 3-week period during which they are to ingest modest doses of cortisol tablets with weekly lowered tapered doses. Thereafter, the participants are to be taught to self-administer cortisol tablets on the as-needed basis to maintain the minimum symptom state. For this, they are to ingest a smaller-dosage, 5-day tapered regimen of cortisol tablets to quench each reoccurring exacerbation of the disease at its earliest stage. Participants are limited to using less than the safe use limit of cortisol per month and are required to include a minimum of 10 days per month during which no cortisol was ingested.
Read the detailed description
OBJECTIVE: To define why and demonstrate how patient self-administration of cortisol with stress management eliminates chronic inflammation pain within fibromyalgia, osteoarthritis, and rheumatoid arthritis.
METHODS: One thousand seventeen hundred and twenty (1,720) participants with chronic inflammation-containing diseases, were brought to a minimum symptom state using daily-administered cortisol tablets. Thereafter, participants used 5-day, small-dosage cortisol regimens to quench subsequent disorder exacerbations to maintain the minimum symptom state. Stressors as emotional traumas, infections, allergies, and injuries were minimized to reduce cortisol consumption and participant discomfort. This protocol is compliant with current United States Food and Drug Administration recommendations for cortisol use applied to corticosteroid-responding disorders.
- Conditions
- Rheumatic Diseases
- Being tested
- Cortisol
- Keywords
- Cortisol
- Medical subject headings
- Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CortisolDrug
Also called microdose therapy
Participants determine when to administer 5-day regimens of cortisol
| Study group | Role | What they receive |
|---|---|---|
| Patient self-administration of cortisol | Experimental | Intervention is patient self-administration of cortisol. Receives: Drug: Cortisol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant evaluation of disease symptom intensity
Participants evaluate 50 symptoms for intensity using the 0 to 10 scale. 0 represents no disease intensity and 10 represents extreme maximum symptom intensity with the intermediate numbers defined as Mild I, Mild II, Mild III, Moderate I, Moderate II, Moderate III, Severe I, Severe II, Severe III for 2 through 9, respectively. The participant-determined disease intensity numbers of the 50 symptoms are added to obtain Total Score for each day.
Measured: Participants determine Total Scores 7 days prior to cortisol initiation to obtain the average baseline Total Score. Participant Total Score change is plotted daily vs. time for study. Outcome: Total Score at 24 weeks vs. baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start1 Jan 2000
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatic 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants follow the same treatment protocol: First, the participants ingest a defined dosage, 3-week treatment of cortisol tablets to achieve a minimum symptom state. Second, after the first is complete, participants are trained to self-administer small-dosage, 5-day regimens of cortisol tablets to quench disease exacerbations to maintain the minimum symptom state.
- Masking
- None (open label)
- Enrolment
- 2,430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helen Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virgil I Stenberg, Ph.D., Principal investigator, University of North Dakota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558971
- Sponsor's protocol ID
- HF 101
- Status last verified
- May 2018
- First submitted
- 3 May 2018
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Plan to publish the study, its results and conclusions
Publications
Stenberg VI, Fiechtner JJ, Rice JR, Miller DR, Johnson LK. Endocrine control of inflammation: rheumatoid arthritis double-blind, crossover clinical trial. Int J Clin Pharmacol Res. 1992;12(1):11-8.
PubMed 1526694Irwin JB, Baldwin AL, Stenberg VI. General theory of inflammation: patient self-administration of hydrocortisone safely achieves superior control of hydrocortisone-responding disorders by matching dosage with symptom intensity. J Inflamm Res. 2019 Jun 13;12:161-166. doi: 10.2147/JIR.S195165. eCollection 2019.
PubMed 31354330
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Self-administration of Cortisol for Cortisol-responding Disorders in Men and Women Over the Age of 17, Demonstration of Double-blind Trial Results
- ClinicalTrials.gov ID
- NCT03558971
- Acronym / sponsor ID
- HF 101
- Conditions
- Rheumatic Diseases
- Keywords
- Cortisol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,430 participants (actual)
- Lead sponsor
- Helen FoundationUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 15 Jun 2018 (actual)
- 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.
Participants diagnosed as having fibromyalgia, osteoarthritis, and rheumatoid arthritis are to be brought to a minimum symptom state using a 3-week period during which they are to ingest modest doses of cortisol tablets with weekly lowered tapered doses. Thereafter, the participants are to be taught to self-administer cortisol tablets on the as-needed basis to maintain the minimum symptom state. For this, they are to ingest a smaller-dosage, 5-day tapered regimen of cortisol tablets to quench each reoccurring exacerbation of the disease at its earliest stage. Participants are limited to using less than the safe use limit of cortisol per month and are required to include a minimum of 10 days per month during which no cortisol was ingested.
Detailed description
OBJECTIVE: To define why and demonstrate how patient self-administration of cortisol with stress management eliminates chronic inflammation pain within fibromyalgia, osteoarthritis, and rheumatoid arthritis.
METHODS: One thousand seventeen hundred and twenty (1,720) participants with chronic inflammation-containing diseases, were brought to a minimum symptom state using daily-administered cortisol tablets. Thereafter, participants used 5-day, small-dosage cortisol regimens to quench subsequent disorder exacerbations to maintain the minimum symptom state. Stressors as emotional traumas, infections, allergies, and injuries were minimized to reduce cortisol consumption and participant discomfort. This protocol is compliant with current United States Food and Drug Administration recommendations for cortisol use applied to corticosteroid-responding disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants follow the same treatment protocol: First, the participants ingest a defined dosage, 3-week treatment of cortisol tablets to achieve a minimum symptom state. Second, after the first is complete, participants are trained to self-administer small-dosage, 5-day regimens of cortisol tablets to quench disease exacerbations to maintain the minimum symptom state.
| Arm | Type | Receives |
|---|---|---|
| Patient self-administration of cortisol | Experimental | Drug: CortisolIntervention is patient self-administration of cortisol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnoses of fibromyalgia, osteoarthritis, or rheumatoid arthritis -
Key exclusion criteria (2 listed)
- Congestive heart failure, stomach ulceration, unstable diabetes, and bipolar disorder
- -
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 |
|---|---|---|
| CortisolAlso: microdose therapyParticipants determine when to administer 5-day regimens of cortisol | Drug | Patient self-administration of cortisol |
Primary outcome
Participant evaluation of disease symptom intensity
Time frame: Participants determine Total Scores 7 days prior to cortisol initiation to obtain the average baseline Total Score. Participant Total Score change is plotted daily vs. time for study. Outcome: Total Score at 24 weeks vs. baseline.
Participants evaluate 50 symptoms for intensity using the 0 to 10 scale. 0 represents no disease intensity and 10 represents extreme maximum symptom intensity with the intermediate numbers defined as Mild I, Mild II, Mild III, Moderate I, Moderate II, Moderate III, Severe I, Severe II, Severe III for 2 through 9, respectively. The participant-determined disease intensity numbers of the 50 symptoms are added to obtain Total Score for each day.
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 15 Jun 2018.
- Background: PubMed 1526694Stenberg VI, Fiechtner JJ, Rice JR, Miller DR, Johnson LK. Endocrine control of inflammation: rheumatoid arthritis double-blind, crossover clinical trial. Int J Clin Pharmacol Res. 1992;12(1):11-8.
- Derived from this study: PubMed 31354330Irwin JB, Baldwin AL, Stenberg VI. General theory of inflammation: patient self-administration of hydrocortisone safely achieves superior control of hydrocortisone-responding disorders by matching dosage with symptom intensity. J Inflamm Res. 2019 Jun 13;12:161-166. doi: 10.2147/JIR.S195165. eCollection 2019.
- Individual participant dataSharing planned: No. Plan to publish the study, its results and conclusions
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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.
Virgil I Stenberg, Ph.D. principal investigator
University of North Dakota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cortisol in people with Rheumatic Diseases, run by Helen Foundation at 1 site in United States.
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 2 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 15 Jun 2018. 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 United States. 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 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?
Participant evaluation of disease symptom intensity (time frame: Participants determine Total Scores 7 days prior to cortisol initiation to obtain the average baseline Total Score. Participant Total Score change is plotted daily vs. time for study. Outcome: Total Score at 24 weeks vs. baseline.). 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 NCT03558971, which also lists 2 linked publications.
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 15 Jun 2018.