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NCT01435629 Clinical Trial

A Survey Collecting Data on Adult Height in Patients With Achondroplasia Treated With Somatropin

Achondroplasia Clinical Trial

Official title:
Open-label, Multicenter, Observational, Non-intervention Study to Retrospectively Evaluate the Efficacy of Norditropin® (Adult Height) in Patients With Achondroplasia/Hypochondroplasia Enrolled in the GH-1941 Study [Follow-up Survey]

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01435629
Other study ID # GH-3907
Secondary ID U1111-1121-7729J
Status Completed
Phase N/A
First received September 14, 2011
Last updated May 4, 2017
Start date November 22, 2012
Est. completion date December 4, 2015

Study information
Verified date May 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is conducted in Japan. The aim of the study is to evaluate the efficacy of somatropin (Norditropin®) on adult height (cm) in patients with achondroplasia / hypochondroplasia enrolled in the GH-1941 study (NCT01516229).

Recruitment information / eligibility
Status Completed
Enrollment 81
Est. completion date December 4, 2015
Est. primary completion date December 4, 2015
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients who were enrolled in the GH-1941 study (1997 to 2006) and expected to theoretically reach the adult height within the study period

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• somatropin
Dosage and administration to be prescribed by the physician as a result of a normal clinical practice.

Locations
Country Name City State
Japan Novo Nordisk Investigational Site Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary To collect change data of adult height (cm) of patients treated with Norditropin® and evaluate the long-term efficacy At year 1, 2, 3, 4, and 5 after the patient has reached adult height or is 18 of age
Secondary To monitor the patients to see if they undergo lower limb lengthening At year 1, 2, 3, 4, and 5 after the patient has reached adult height or is 18 of age
See also
  Status Clinical Trial Phase
Recruiting NCT05353192 - A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children With Achondroplasia Phase 4
Recruiting NCT05328050 - Registry for Patients With Achondroplasia / Hypochondroplasia (OMPR-Ach/Hy)
Completed NCT05659719 - A Study to Learn About Recifercept in Patients With Achondroplasia
Active, not recruiting NCT04554940 - A Clinical Trial to Evaluate Safety of Vosoritide in At-risk Infants With Achondroplasia Phase 2
Enrolling by invitation NCT06164951 - A Study to Evaluate the Efficacy and Safety of Infigratinib in Children and Adolescents With Achondroplasia Phase 3
Completed NCT03583697 - A Clinical Trial to Evaluate the Safety and Efficacy of BMN 111 in Infants and Young Children With Achondroplasia Phase 2
Completed NCT01516229 - Special Survey for Long Term Application N/A
Completed NCT03872531 - Lifetime Impact Study for Achondroplasia
Active, not recruiting NCT05598320 - A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Children With Achondroplasia Phase 2/Phase 3
Terminated NCT05813314 - Bioequivalence Study to Compare Two Injection Devices for BMN 111 in Healthy Participants Phase 1
Recruiting NCT04265651 - Study of Infigratinib in Children With Achondroplasia Phase 2
Recruiting NCT05603936 - Adaption and Testing of the Quality of Life in Short Stature Youth (QoLISSY) Questionnaire for Parents With Children From 0-4
Completed NCT03780153 - The Norwegian Adult Achondroplasia Study
Active, not recruiting NCT04085523 - A Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of TransCon CNP Administered Once Weekly in Prepubertal Children With Achondroplasia Phase 2
Enrolling by invitation NCT05929807 - A Clinical Trial to Investigate Long-term Safety, Tolerability, and Efficacy of Weekly Subcutaneous Doses With TransCon CNP in Children and Adolescents With Achondroplasia Phase 2/Phase 3
Completed NCT03875534 - A Multi-center, Longitudinal, Observational Study of Children With Achondroplasia
Terminated NCT03794609 - Observational Study Investigating Clinical & Anthropometric Characteristics of Children With Achondroplasia.
Active, not recruiting NCT03989947 - An Extension Study to Evaluate Safety and Efficacy of BMN 111 in Children With Achondroplasia Phase 2
Active, not recruiting NCT05246033 - A Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of Multiple Subcutaneous Doses of TransCon CNP Administered Once Weekly in Children With Achondroplasia Phase 2
Active, not recruiting NCT02724228 - A Study to Evaluate Long-Term Safety, Tolerability, & Efficacy of BMN 111 in Children With Achondroplasia (ACH) Phase 2

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