Efficacy & Safety of an Oral Growth Hormone Drug in the Treatment of

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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:

1. To evaluate the efficacy of MK-0677 25 mg in primary fibromyalgia subjects over a 24-week treatment period, as assessed by the FIQ.

2. 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:

1. MK-0677 25 mg is superior to placebo in reducing muscle tenderness, as assessed by the Fibromyalgia Myalgic Score (FMyS).

2. 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).

3. 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00116129
Study type	Interventional
Source	Bennett, Robert, M.D.
Contact
Status	Completed
Phase	Phase 2
Start date	July 2005
Completion date	April 2008

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Efficacy and Safety of an Oral Growth Hormone Drug in the Treatment of Fibromyalgia

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms