FibromyalgiaEarly Phase 1NCT00236925
Efficacy Study of Low-Dose Hydrocortisone Treatment for Fibromyalgia
A Early Phase 1 study testing Low dose Hydrocortisone in people with Fibromyalgia, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
This study is based on clinical findings that some patients with fibromyalgia have a tendency towards lower levels of the stress hormone cortisol. The hypothesis to be tested in this study is that the administration of a very low-dose of cortisol which has no side effects corrects this deficiency and results in an… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Low dose Hydrocortisone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- May 2003to Jun 2007
- Phase
- Early Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- FMS diagnosis according to the American College of Rheumatology 1990 Criteria.
- Age between 18 and 60 years
Who cannot join
- Disease states representing contraindications to the administration of glucocorticoids (tuberculosis, gastric- and duodenal ulcers, Cushing's disease, osteoporosis, hypertension, pregnancy and lactation, psychosis, glaucoma, diabetes mellitus, thrombophilia, active or chronic bacterial or viral infections, hypothyreosis, cirrhosis)
- Severe or chronic somatic diseases
- Psychiatric diseases according to DSM-IV (except PTSD, minor depressive episodes, minor personality disorders)
- Body weight >20% above or below normal
- Changes in pharmacologic or psychotherapeutic management less than 3 months ago
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind Crossover Within Subject Study on Low-Dose Hydrocortisone for Fibromyalgia
This study is based on clinical findings that some patients with fibromyalgia have a tendency towards lower levels of the stress hormone cortisol. The hypothesis to be tested in this study is that the administration of a very low-dose of cortisol which has no side effects corrects this deficiency and results in an improvement of symptoms
Read the detailed description
Fibromyalgia (FMS) is regarded as one of the most important chronic pain syndromes with a high prevalence in the general population.
Hypotheses to be tested in this study:
- Impaired glucocorticoid signaling is associated in a failure to terminate the chronic stress response seen in patients with FMS.
- Low-dose hydrocortisone in patients with FMS results in a reduction in pain and other stress-related symptoms of FMS
Intervention:
2 x 5 mg of hydrocortisone given at noon and in the evening
Study design:
Double-blind, randomized, cross-over, within-subject
Presumed mechanism of main hydrocortisone effect:
- Improvements in FMS symptoms representing (functional) hypocortisolism
- Increased pain threshold
Expected results:
- Moderate reductions in physical impairment, fatigue, and stiffness
- Improvements in sleep quality
- Decline in pain intensity Inclusion criteria
- FMS diagnosis according to the American College of Rheumatology 1990 Criteria
- Age between 18 and 60 years
Exclusion criteria
- Disease states representing contraindications to the administration of glucocorticoids (tuberculosis, gastric- and duodenal ulcers, Cushing's disease, osteoporosis, hypertension, pregnancy and lactation, psychosis, glaucoma, diabetes mellitus, thrombophilia, active or chronic bacterial or viral infections, hypothyreosis, cirrhosis).
- Severe or chronic somatic diseases.
- Psychiatric diseases according to DSM-IV (except PTSD, minor depressive episodes, minor personality disorders).
- Body weight >20% above or below normal.
- Changes in pharmacologic or psychotherapeutic management less than 3 months ago.
- Age < 18 years
Proposed outcome measures
- Primary: FMS symptoms, pain scores, tenderness at tender points
- Secondary: Chronic stress symptoms, health-related quality of life
Possible benefit and use of data from the trial
This trial could help to identify glucocorticoid resistance as a major mechanism underlying the sustained stress - reactions seen in FMS and establish low-dose hydrocortisone as a useful drug for treatment of stress-related disorders.
- Conditions
- Fibromyalgia
- Being tested
- Low dose Hydrocortisone, Placebo
- Keywords
- Fibromyalgia, Cortisol, Hydrocortisone, Stress
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose HydrocortisoneDrug
Also called Cortisol
Hydrocortisone 10 mg daily
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Low dose Hydrocortisone | Active comparator | Low Dose Hydrocortisone Receives: Drug: Low dose Hydrocortisone; Drug: Placebo |
| Placebo | Placebo comparator | Placebo Receives: Drug: Low dose Hydrocortisone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia symptoms
Measured: 3 months
Secondary outcomes (4)
Chronic stress symptoms
Measured: 3 months
Health-related quality of life
Measured: 3 months
Life satisfaction
Measured: 3 months
Infection
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startMay 2003
- Primary completionMay 2007
- Study completionJun 2007
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 FibromyalgiaStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Principal investigator, Gustav Schelling,MD, Ludwig-Maximilians - University of Munich
- Investigators
- Gustav Schelling, MD, PhD, Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00236925
- Sponsor's protocol ID
- 348/02
- Status last verified
- Mar 2024
- First submitted
- 10 Oct 2005
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Aerni A, Traber R, Hock C, Roozendaal B, Schelling G, Papassotiropoulos A, Nitsch RM, Schnyder U, de Quervain DJ. Low-dose cortisol for symptoms of posttraumatic stress disorder. Am J Psychiatry. 2004 Aug;161(8):1488-90. doi: 10.1176/appi.ajp.161.8.1488.
PubMed 15285979
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Crossover Within Subject Study on Low-Dose Hydrocortisone for Fibromyalgia
- ClinicalTrials.gov ID
- NCT00236925
- Acronym / sponsor ID
- 348/02
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Cortisol, Hydrocortisone, Stress
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- May 2003
- Primary completion
- May 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 12 Oct 2005 (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 is based on clinical findings that some patients with fibromyalgia have a tendency towards lower levels of the stress hormone cortisol. The hypothesis to be tested in this study is that the administration of a very low-dose of cortisol which has no side effects corrects this deficiency and results in an improvement of symptoms
Detailed description
Fibromyalgia (FMS) is regarded as one of the most important chronic pain syndromes with a high prevalence in the general population.
Hypotheses to be tested in this study:
- Impaired glucocorticoid signaling is associated in a failure to terminate the chronic stress response seen in patients with FMS.
- Low-dose hydrocortisone in patients with FMS results in a reduction in pain and other stress-related symptoms of FMS
Intervention:
2 x 5 mg of hydrocortisone given at noon and in the evening
Study design:
Double-blind, randomized, cross-over, within-subject
Presumed mechanism of main hydrocortisone effect:
- Improvements in FMS symptoms representing (functional) hypocortisolism
- Increased pain threshold
Expected results:
- Moderate reductions in physical impairment, fatigue, and stiffness
- Improvements in sleep quality
- Decline in pain intensity Inclusion criteria
- FMS diagnosis according to the American College of Rheumatology 1990 Criteria
- Age between 18 and 60 years
Exclusion criteria
- Disease states representing contraindications to the administration of glucocorticoids (tuberculosis, gastric- and duodenal ulcers, Cushing's disease, osteoporosis, hypertension, pregnancy and lactation, psychosis, glaucoma, diabetes mellitus, thrombophilia, active or chronic bacterial or viral infections, hypothyreosis, cirrhosis).
- Severe or chronic somatic diseases.
- Psychiatric diseases according to DSM-IV (except PTSD, minor depressive episodes, minor personality disorders).
- Body weight >20% above or below normal.
- Changes in pharmacologic or psychotherapeutic management less than 3 months ago.
- Age < 18 years
Proposed outcome measures
- Primary: FMS symptoms, pain scores, tenderness at tender points
- Secondary: Chronic stress symptoms, health-related quality of life
Possible benefit and use of data from the trial
This trial could help to identify glucocorticoid resistance as a major mechanism underlying the sustained stress - reactions seen in FMS and establish low-dose hydrocortisone as a useful drug for treatment of stress-related disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose Hydrocortisone | Active comparator | Drug: Low dose Hydrocortisone, Drug: PlaceboLow Dose Hydrocortisone |
| Placebo | Placebo comparator | Drug: Low dose Hydrocortisone, Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- FMS diagnosis according to the American College of Rheumatology 1990 Criteria.
- Age between 18 and 60 years
Key exclusion criteria (6 listed)
- Disease states representing contraindications to the administration of glucocorticoids (tuberculosis, gastric- and duodenal ulcers, Cushing's disease, osteoporosis, hypertension, pregnancy and lactation, psychosis, glaucoma, diabetes mellitus, thrombophilia, active or chronic bacterial or viral infections, hypothyreosis, cirrhosis)
- Severe or chronic somatic diseases
- Psychiatric diseases according to DSM-IV (except PTSD, minor depressive episodes, minor personality disorders)
- Body weight >20% above or below normal
- Changes in pharmacologic or psychotherapeutic management less than 3 months ago
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 |
|---|---|---|
| Low dose HydrocortisoneAlso: CortisolHydrocortisone 10 mg daily | Drug | Low dose Hydrocortisone, Placebo |
| PlaceboPlacebo | Drug | Low dose Hydrocortisone, Placebo |
Primary outcome
Fibromyalgia symptoms
Time frame: 3 months
4 secondary outcomes
Chronic stress symptoms
Time frame: 3 months
Health-related quality of life
Time frame: 3 months
Life satisfaction
Time frame: 3 months
Infection
Time frame: 3 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 15 Mar 2024.
- Background: PubMed 15285979Aerni A, Traber R, Hock C, Roozendaal B, Schelling G, Papassotiropoulos A, Nitsch RM, Schnyder U, de Quervain DJ. Low-dose cortisol for symptoms of posttraumatic stress disorder. Am J Psychiatry. 2004 Aug;161(8):1488-90. doi: 10.1176/appi.ajp.161.8.1488.
- Homepage of the Dept. of Anaesthesiology of the University of MunichLink provided by the sponsor.
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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.
Gustav Schelling, MD, PhD principal investigator
Ludwig-Maximilians - University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Low dose Hydrocortisone in people with Fibromyalgia, run by Ludwig-Maximilians - University of Munich 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 2 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 15 Mar 2024. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Fibromyalgia symptoms (time frame: 3 months). 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 NCT00236925, 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 15 Mar 2024.