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Somapacitan vs. Norditropin® for Small for Gestational Age (SGA) Children
Study Summary
This trial is comparing two medicines to see if they are effective in treating children who were born small and stayed small. One medicine is given once a week, and the other is given once a day. The trial will last for four years, and participants will have nine clinic visits.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 3 trial • 62 Patients • NCT03075644Trial Design
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Who is running the clinical trial?
Media Library
- I am a boy aged 2.5 to 11 years with small testes.You have a medical condition that could affect your growth or make it difficult to measure your height accurately.I have had cancer before, including brain tumors.I am not taking medications like methylphenidate that affect growth.My child has been on high-dose asthma medication for over a month in the past year.I haven't taken steroids for inflammation for more than 2 weeks in the last 3 months.I am a girl aged 2.5-10, born small for my age, with slow growth and no hormone treatments.I have been diagnosed with ADHD.My child has a growth hormone deficiency.
- Group 1: 0.067 mg/kg Norditropin®
- Group 2: 0.16 mg/kg somapacitan
- Group 3: 0.035 mg/kg Norditropin®
- Group 4: 0.24 mg/kg somapacitan
- Group 5: 0.20 mg/kg somapacitan
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is somapacitan typically used to heal?
"Somapacitan has clinical applications in treating general surgery patients, those with short stature, and those with open epiphyses."
What is the largest number of people who can be included in this research project?
"Unfortunately, this study isn't looking for any more patients at the moment. The listing was first put up on July 4th, 2019, and the most recent update was on September 15th, 2022. However, there are 12 other trials for patients with dwarfism that are recruiting and 35 for somapacitan."
Has somapacitan been cleared for public consumption in the United States?
"Somapacitan has not been proven effective in any clinical trials, however it has showed some signs of being safe. For this reason, it received a score of 2."
What are the other scientific investigations into somapacitan's effects?
"Somapacitan, a novel drug, is being investigated in 35 clinical trials, 14 of which are in Phase 3. Currently, 645 medical centres across the globe are running studies on somapacitan, with several of these locations in Philadelphia, Pennsylvania."
Would I be able to join this scientific research if I wanted to?
"As this is a clinical trial investigating a potential treatment for dwarfism, patients must have the condition to be eligible. In addition, all participants must be aged 2-11. A total of 62 individuals are being recruited for the trial."
Does the age limit for this test allow for people in their seventies to participate?
"Children aged 2-11 may be eligible for this study, based on the inclusion criteria."
How many different hospitals are currently conducting this trial?
"Currently, there are 14 sites conducting this trial with more locations in New york, Oklahoma City and Minneapolis. If you're interested in enrolling, try to select a site that is close to your location to reduce travel times."
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