At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 64 enrolled
Drug / intervention
Ibutamoren Mesylate (MK-0677)drug
Likely dose
Ibutamoren Mesylate (MK-0677) 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of MK-0677 25 mg in the Treatment of Primary Fibromyalgia
In Brief
A Phase 2 clinical trial evaluating Ibutamoren Mesylate (MK-0677) for Fibromyalgia. Completed, enrolled 64 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2005
Enrollment StartJul 2005
Primary CompletionJan 2008
Study CompletionApr 2008
TodayJul 2026
First PostedJun 28, 2005
Enrollment StartJul 1, 2005
Primary CompletionJan 1, 2008
Study CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 21.0 years ago
Interventions
Ibutamoren Mesylate (MK-0677)drug
Ibutamoren Mesylate 25 mg/day