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Hormone Therapy

Norditropin for Dwarfism

Phase 1 & 2
Waitlist Available
Led By Philippe Backeljauw, MD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up knee mri data collected from baseline visit to 3 year study visit
Awards & highlights

Study Summary

This trial will study the effects of daily growth hormone medication on children with a deficiency that causes stunted growth. The children will be monitored for 2 years to see if the medication helps them grow.

Eligible Conditions
  • Dwarfism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~knee mri data collected from baseline visit to 3 year study visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and knee mri data collected from baseline visit to 3 year study visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Height Velocity After Three Years of Treatment with recombinant human growth hormone (rhGH)
Secondary outcome measures
Describe Clinical Features of ACAN Deficiency

Side effects data

From 2018 Phase 3 trial • 62 Patients • NCT03075644
48%
Nasopharyngitis
9%
Headache
7%
Influenza
7%
Arthralgia
7%
Gingivitis
7%
Rhinitis
4%
Back pain
4%
Hypoaesthesia
2%
Pharyngitis
2%
Inguinal hernia
2%
Respiratory tract infection
2%
Large intestine polyp
2%
Rhinitis allergic
2%
Chest pain
2%
Oropharyngeal pain
2%
Gastroenteritis
2%
Head injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
Somapacitan
Norditropin®

Trial Design

1Treatment groups
Experimental Treatment
Group I: Growth Hormone Treatment for Participants with ACAN DeficiencyExperimental Treatment1 Intervention
Pre-pubertal children with ACAN deficiency on daily growth hormone (Norditropin) regimen for a 3 year period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Norditropin
2017
Completed Phase 3
~600

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,574 Total Patients Enrolled
2 Trials studying Dwarfism
8 Patients Enrolled for Dwarfism
Philippe Backeljauw, MDPrincipal InvestigatorCincinnati Childrens Hospital Medical Center
1 Previous Clinical Trials
7 Total Patients Enrolled
1 Trials studying Dwarfism
7 Patients Enrolled for Dwarfism

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical ailments is Norditropin typically prescribed for?

"Norditropin is a viable treatment option for general surgery, short stature, and open epiphyses."

Answered by AI

What is the scope of participants in this clinical investigation?

"At this time, recruitment for this trial has been halted. The post was first made on February 1st 2018 and the latest update occured on February 9th 2022. For those looking to participate in other trials, there are 13 studies enlisting patients with stunted growth and 34 clinical trails seeking candidates using Norditropin as a treatment option."

Answered by AI

Is this a pioneering clinical trial?

"For over 15 years, trials for Norditropin have been conducted in 41 countries and 151 cities. BioPartners GmbH was the first to sponsor a trial with 144 participants in 2005. Since then, 209 clinical studies have taken place."

Answered by AI

Have any prior experiments been conducted using Norditropin?

"Currently, 34 clinical trials for Norditropin are ongoing. 13 of those have entered phase 3, and there are 565 locations across the nation that offer studies with this medication. The majority of these sites can be found in Philadelphia, Pennsylvania."

Answered by AI

Is recruitment for this research endeavor still underway?

"This medical study is no longer open to enrollees. It was initially posted in February of 2018 and last updated on the 9th of February 2022. For those searching for alternate studies, there are 13 trials recruiting participants with short stature and a further 34 involving Norditropin actively seeking out patients."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Growth Hormone Treatment in Patients With Aggrecan (ACAN) Deficiency
2018. "Growth Hormone Treatment in Patients With Aggrecan (ACAN) Deficiency". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03288103.
~3 spots leftby Apr 2025
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