Somatropin for Growth Disorders

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Children's National Hospital, Washington, United States
Growth Disorders
Somatropin - Drug
Eligibility
Any Age
Male
What conditions do you have?
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Study Summary

This trial will give growth hormone to one patient with a genetic mutation that causes too much growth hormone binding protein. They will monitor how well the patient responds to the therapy. Somatropin is used to treat Growth Disorders and has been previously approved by the FDA for a different condition. No patients in this trial will receive a placebo.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Growth Disorders

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 1 year

1 year
Growth Velocity
Growth hormone dose
Height standard deviation
Height standard deviation score

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Growth Disorders

Side Effects for

Somatropin
21%Headache
15%Vomiting
10%Upper respiratory tract infection
9%Injection site bruising
7%Pharyngitis streptococcal
7%Rash
6%Pyrexia
6%Nasopharyngitis
This histogram enumerates side effects from a completed 2017 Phase 4 trial (NCT02311894) in the Somatropin ARM group. Side effects include: Headache with 21%, Vomiting with 15%, Upper respiratory tract infection with 10%, Injection site bruising with 9%, Pharyngitis streptococcal with 7%.

Trial Design

1 Treatment Group

Growth hormone
1 of 1
Experimental Treatment

1 Total Participants · 1 Treatment Group

Primary Treatment: Somatropin · No Placebo Group · Phase 2

Growth hormone
Drug
Experimental Group · 1 Intervention: Somatropin · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Somatropin
2015
Completed Phase 4
~68040

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
Closest Location: Children's National Hospital · Washington, United States
Photo of washington 1Photo of washington 2Photo of washington 3
2013First Recorded Clinical Trial
1 TrialsResearching Growth Disorders
12 CompletedClinical Trials

Who is running the clinical trial?

Children's National Research InstituteLead Sponsor
190 Previous Clinical Trials
199,718 Total Patients Enrolled
Andrew Dauber, MDPrincipal InvestigatorChildren's National Research Institute
2 Previous Clinical Trials
11 Total Patients Enrolled

Eligibility Criteria

Age Any Age · Male Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing to comply with all study procedures and are available for the duration of the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.