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| Sponsored by: |
Centro Medico Teknon |
|---|---|
| Information provided by: | Centro Medico Teknon |
| ClinicalTrials.gov Identifier: | NCT00497562 |
Purpose
There are evidences of functional growth hormone (GH) deficiency, expressed by means of low serum levels of insulin-like growth factor 1 (IGF-1), in a subset of fibromyalgia patients. The efficacy of low GH doses versus placebo has been demonstrated in this population. We assessed the efficacy and safety of GH added to standard therapy compared to standard therapy alone in the treatment of severe, prolonged and well-treated fibromialgya patients with low IGF-1 levels.
| Condition | Intervention | Phase |
|---|---|---|
|
Fibromyalgia Growth Hormone Deficiency |
Drug: sc recombinant growth hormone + amitriptyline, fluoxetine and tramadol (treated group) Drug: amitriptyline, fluoxetine and tramadol alone (control group) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Exploratory Study to Investigate the Efficacy and Safety of Recombinant Growth Hormone as Add-on Treatment in Patients With Severe Fibromialgia |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Spain | |
| Endocrinology Department CM Teknon | |
| Barcelona, Spain, 08022 | |
| Principal Investigator: | Guillem Cuatrecasas, MD | CM Teknon Endocrinology Head Department |
| Study Chair: | Albert Nadal, MD | CM Teknon Rheumatology Head Department |
More Information
| Study ID Numbers: | FibTek-0301, 03-0453 (AGEMED) |
| Study First Received: | July 5, 2007 |
| Last Updated: | July 5, 2007 |
| ClinicalTrials.gov Identifier: | NCT00497562 History of Changes |
| Health Authority: | Spain: Agencia Española del Medicamento y productos sanitarios |
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Fibromyalgia growth hormone IGF-1 FIQ |
|
Bone Diseases, Endocrine Dwarfism Neurotransmitter Agents Adrenergic Agents Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Psychotropic Drugs Pain Dwarfism, Pituitary Brain Diseases Bone Diseases Hormones Hypopituitarism Musculoskeletal Diseases Neuromuscular Diseases |
Bone Diseases, Developmental Analgesics Antidepressive Agents, Second-Generation Analgesics, Opioid Antidepressive Agents Hypothalamic Diseases Pituitary Diseases Hypopituitary Dwarfism Myofascial Pain Syndromes Fibromyalgia Tramadol Central Nervous System Depressants Central Nervous System Diseases Endocrine System Diseases Narcotics |
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Bone Diseases, Endocrine Dwarfism Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Psychotropic Drugs Dwarfism, Pituitary Brain Diseases Bone Diseases Hormones Hypopituitarism |
Musculoskeletal Diseases Neuromuscular Diseases Sensory System Agents Therapeutic Uses Bone Diseases, Developmental Analgesics Antidepressive Agents, Second-Generation Analgesics, Opioid Antidepressive Agents Hypothalamic Diseases Pituitary Diseases Myofascial Pain Syndromes Fibromyalgia Tramadol Nervous System Diseases |