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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT01435629

First received: September 14, 2011

Last updated: May 4, 2017

Last verified: May 2017

History of Changes

Purpose

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).

Condition	Intervention
Genetic Disorder Achondroplasia	Drug: somatropin


Study Type:	Observational
Study Design:	Observational Model: Other Time Perspective: Retrospective
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]

Resource links provided by NLM:

Genetics Home Reference related topics: achondroplasia hypochondroplasia

Drug Information available for: Somatropin

Genetic and Rare Diseases Information Center resources: Achondroplasia Hypochondroplasia Mucopolysaccharidosis Type IV

U.S. FDA Resources

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:

To collect change data of adult height (cm) of patients treated with Norditropin® and evaluate the long-term efficacy [ Time Frame: At year 1, 2, 3, 4, and 5 after the patient has reached adult height or is 18 of age ]

Secondary Outcome Measures:

To monitor the patients to see if they undergo lower limb lengthening [ Time Frame: At year 1, 2, 3, 4, and 5 after the patient has reached adult height or is 18 of age ]


Enrollment:	81
Actual Study Start Date:	November 22, 2012
Study Completion Date:	December 4, 2015
Primary Completion Date:	December 4, 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Norditropin®	Drug: somatropin Dosage and administration to be prescribed by the physician as a result of a normal clinical practice.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients enrolled in the GH-1941 study (NCT01516229) expected to achieve the adult height by 2015 and available for follow-up by the investigator

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435629

Locations


Japan
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005

Sponsors and Collaborators

Novo Nordisk A/S

Investigators


Study Director:	Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site


Responsible Party:	Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT01435629 History of Changes
Other Study ID Numbers:	GH-3907 U1111-1121-7729 ( Other Identifier: WHO ) JapicCTI-111622 ( Other Identifier: JAPIC )
Study First Received:	September 14, 2011
Last Updated:	May 4, 2017

Additional relevant MeSH terms:


Achondroplasia Dwarfism Bone Diseases, Developmental Bone Diseases	Musculoskeletal Diseases Osteochondrodysplasias Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on June 23, 2017

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