CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 113 enrolled
Drug / intervention
Saizen® +1 moredrug
Likely dose
Saizen® 0.006 milligramfrom 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.

Search/NCT00933686
NCT00933686Phase 3Completed
CompareCT.gov

Growth Hormone Treatment of Severe Fibromyalgia Syndrome Associated With Functional Failure of Somatotropic Axis. A Multicentre, Randomized, Double-blind, Placebo-controlled Study.

Merck KGaA, Darmstadt, Germany·interventional·Posted Jul 7, 2009·Updated Aug 2, 2013

In Brief

A Phase 3 clinical trial evaluating Saizen® and Placebo and Saizen® for Fibromyalgia. Completed, enrolled 113 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the efficacy of recombinant human growth hormone (r-hGH) treatment in severe fibromyalgia subjects with growth axis dysfunction.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesSpain
CollaboratorsMerck, S.L., Spain

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 7, 2009
Enrollment StartDec 1, 2007
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 17.0 years ago

Interventions

Saizen®drug

Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) will be administered subcutaneously daily for 12 months. Dose will be titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) is less than 50 percent of the baseline value. Dose titrations will be made at Month 1, 3, 7 and 9.

Placebo and Saizen®drug

Placebo matched to Saizen® will be administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose will be titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) is less than 50 percent of the baseline value. Dose titrations will be made at Month 7 and 9.