Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Ludwig-Maximilians - University of Munich University of Zurich |
---|---|
Information provided by: | Ludwig-Maximilians - University of Munich |
ClinicalTrials.gov Identifier: | NCT00236925 |
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
Condition | Intervention |
---|---|
Fibromyalgia |
Drug: Hydrocortisone (low-dose) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind Crossover Within Subject Study on Low-Dose Hydrocortisone for Fibromyalgia |
Enrollment: | 30 |
Study Start Date: | May 2003 |
Study Completion Date: | June 2007 |
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:
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:
Expected results:
Exclusion criteria
Proposed outcome measures
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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany, Bavaria | |
Ludwig-Maximilians University | |
Muenchen, Bavaria, Germany, 81377 |
Principal Investigator: | Gustav Schelling, MD, PhD | Ludwig-Maximilians - University of Munich |
Study ID Numbers: | 348/02 |
Study First Received: | October 10, 2005 |
Last Updated: | June 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00236925 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Fibromyalgia Cortisol Hydrocortisone Stress |
Hydrocortisone Muscular Diseases Cortisol succinate Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes |
Fibromyalgia Stress Pain Hydrocortisone acetate Rheumatic Diseases |
Anti-Inflammatory Agents Therapeutic Uses Nervous System Diseases Pharmacologic Actions |