Efficacy and Safety of an Oral Growth Hormone Drug in the Treatment of Fibromyalgia
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|ClinicalTrials.gov Identifier: NCT00116129|
Recruitment Status : Completed
First Posted : June 28, 2005
Last Update Posted : August 6, 2012
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Drug: Ibutamoren Mesylate (MK-0677)||Phase 2|
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:
- To evaluate the efficacy of MK-0677 25 mg in primary fibromyalgia subjects over a 24-week treatment period, as assessed by the FIQ.
- To evaluate the safety and tolerability of MK-0677 25 mg in subjects with fibromyalgia.
The secondary aims of this study are to determine whether:
- MK-0677 25 mg is superior to placebo in reducing muscle tenderness, as assessed by the Fibromyalgia Myalgic Score (FMyS).
- MK-0677 25 mg is superior to placebo in improving the subjects' global perception of change in fibromyalgia symptoms, as assessed by the Subjects' Global Impression of Change Questionnaire (PGIC).
- MK-0677 25 mg is superior to placebo in improving the subjects' quality of life, as assessed by the Quality of Life Questionnaire (QOL).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||July 2005|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||April 2008|
Placebo Comparator: Placebo
Drug: Ibutamoren Mesylate (MK-0677)
Ibutamoren Mesylate 25 mg/day
- MK-0677 25 mg is superior to placebo in reducing symptoms of fibromyalgia, as assessed by the Fibromyalgia Impact Questionnaire (FIQ) over a 24-week treatment period [ Time Frame: Six months ]
- MK-0677 25 mg is generally safe and well tolerated in subjects with fibromyalgia [ Time Frame: Six months ]
- MK-0677 25 mg is superior to placebo in improving the subjects' global perception of change in fibromyalgia symptoms, as assessed by the Subjects' Global Impression of Change Questionnaire (PGIC) [ Time Frame: Six months ]
- MK-0677 25 mg is superior to placebo in improving the subjects' quality of life, as assessed by the Quality of Life Questionnaire (QOL) [ Time Frame: Six months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00116129
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Robert Bennett, MD||Oregon Health and Science University|