Post Marketing Surveillance on Long-term Use With Norditropin® (Short Stature Due to Noonan Syndrome)
NCT ID: NCT03435627
Last Updated: 2022-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
71 participants
OBSERVATIONAL
2018-02-26
2022-01-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Observational Study of the Safety and Efficacy of Norditropin® in Adult Patients With Growth Hormone Deficiency
NCT01109017
A Survey Collecting Data on Adult Height in Patients With Achondroplasia Treated With Somatropin
NCT01435629
Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome
NCT01604161
Special Survey for Long Term Application
NCT01516229
Investigating the Long-term Efficacy and Safety of Two Doses of NN-220 (Somatropin) in Short Stature Due to Noonan Syndrome
NCT01927861
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Norditropin® (naïve participants)
The treatment period of Norditropin® for naïve participants will be up to 208 weeks.
Somatropin
Participants will be treated with commercially available Norditropin® (somatropin) according to routine clinical practice at the discretion of the treating physician.
Norditropin® (non-naïve participants)
The treatment period of Norditropin® for non-naïve participants will be up to 442 weeks.
Somatropin
Participants will be treated with commercially available Norditropin® (somatropin) according to routine clinical practice at the discretion of the treating physician.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Somatropin
Participants will be treated with commercially available Norditropin® (somatropin) according to routine clinical practice at the discretion of the treating physician.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The decision to initiate treatment with commercially available Norditropin® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
* For non-naïve patients; patients who were previously enrolled in study: GHLIQUID-4020.
* For naïve patients; short stature due to Noonan syndrome diagnosed by the physician and a decision to initiate treatment with Norditropin® has been made by the patient/parent and the physician. At study sites, all patients will be registered consecutively from the first patient after approval date (consecutively registered system).
* Male or female, 3 years old or over, bone age: less than 17 years old for male / less than 15 years old for female.
Exclusion Criteria
* Known or suspected allergy to study products or related products.
* In case of naïve patients, patients who have received growth hormone (GH) products for treatment of indication other than short stature due to Noonan syndrome before approval date of Noonan indication.
3 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novo Nordisk A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Reporting Anchor and Disclosure (1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novo Nordisk Investigational Site
Asahikawa, Hokkaido, , Japan
Novo Nordisk Investigational Site
Fukuoka, , Japan
Novo Nordisk Investigational Site
Kanagawa, , Japan
Novo Nordisk Investigational Site
Kanagawa, , Japan
Novo Nordisk Investigational Site
Kyoto, , Japan
Novo Nordisk Investigational Site
Kyoto, , Japan
Novo Nordisk Investigational Site
Maebashi-shi, Gunma, , Japan
Novo Nordisk Investigational Site
Miyazaki, , Japan
Novo Nordisk Investigational Site
Nagoya, Aichi, , Japan
Novo Nordisk Investigational Site
Niigata-shi, Niigata, , Japan
Novo Nordisk Investigational Site
Osaka, , Japan
Novo Nordisk Investigational Site
Osaka, , Japan
Novo Nordisk Investigational Site
Ōita, , Japan
Novo Nordisk Investigational Site
Saitama-shi, Saitama, , Japan
Novo Nordisk Investigational Site
Sapporo, Hokkaido, , Japan
Novo Nordisk Investigational Site
Sendai-shi, Miyagi, , Japan
Novo Nordisk Investigational Site
Shizuoka, , Japan
Novo Nordisk Investigational Site
Tochigi, , Japan
Novo Nordisk Investigational Site
Tokyo, , Japan
Novo Nordisk Investigational Site
Tokyo, , Japan
Novo Nordisk Investigational Site
Tokyo, , Japan
Novo Nordisk Investigational Site
Tokyo, , Japan
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1191-3084
Identifier Type: OTHER
Identifier Source: secondary_id
GHLIQUID-4358
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.