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Sponsors and Collaborators: |
Bennett, Robert, M.D. Merck |
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Information provided by: | Bennett, Robert, M.D. |
ClinicalTrials.gov Identifier: | NCT00116129 |
This is a 24-week, randomized, double-blind, placebo-controlled, trial to evaluate the safety, tolerability and efficacy of an orally administered growth hormone stimulating drug, (code named MK-0677) in the treatment of female subjects with primary fibromyalgia. The basis for this study is the observation that many fibromyalgia patients are growth hormone deficient; an earlier study of injectable growth hormone had shown benefit in this population of fibromyalgia patients.
Condition | Intervention | Phase |
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Fibromyalgia |
Drug: Ibutamoren Mesylate (MK-0677) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of MK-0677 25 mg in the Treatment of Primary Fibromyalgia |
Estimated Enrollment: | 60 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | January 2008 |
This study examines whether MK-0677 treatment will improve symptoms of fibromyalgia (FM).
The rationale for this study is the observation that many fibromyalgia patients are growth hormone deficient in terms of low levels of IGF-1, and that improving IGF-1 levels with growth hormone injections has been shown to improve fibromyalgia symptoms.
MK-0677 is an orally administered growth hormone secretagogue manufactured by Merck & Co., Inc. that acts on the growth hormone secretagogue receptor in the anterior pituitary to stimulate the release of growth hormone. This pathway represents an additional regulation of growth hormone release from pituitary somatotrophs to that mediated by growth hormone releasing hormone (stimulating) and somatostatin (inhibitory). Both stimulatory pathways lead to a pulsatile release of growth hormone, with approximately 4 hour intervals between peak levels. This growth hormone secretion leads to a rapid and robust up regulation of IGF-1 levels by about 50 to 100% that can be maintained with chronic therapy at a dose of 25 mg/day.
The primary aims of this study are:
The secondary aims of this study are to determine whether:
Ages Eligible for Study: | 30 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subject is using any of the following medications : heparin, ticlopidine, ginko (in subjects taking warfarin), oral steroids (>/= 7 days per month), chronic use of strong CYP3A4 inhibitors (HIV protease inhibitors, macrolide antibiotics and nefazodone), chronic use of CYP3A4 inducers (carbamazepine, phenytoin, rifampin, and St. John’s Wort).
p. Subject has received an investigational drug or device within 30 days of study entry.
United States, Oregon | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97239 |
Principal Investigator: | Robert Bennett, MD | Oregon Health and Science University |
Study ID Numbers: | MK-0677/FM |
Study First Received: | June 27, 2005 |
Last Updated: | July 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00116129 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Fibromyalgia Treatment Growth hormone |
IGF-1 MK-0677 Oral growth hormone secretagogue |
Muscular Diseases Neuromuscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes |
Fibromyalgia Pain Rheumatic Diseases |
Nervous System Diseases |