A Survey Collecting Data on Adult Height in Patients With Achondroplasia Treated With Somatropin
This study is enrolling participants by invitation only.
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01435629
First received: September 14, 2011
Last updated: September 16, 2013
Last verified: September 2013
History of Changes
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  Purpose
This study is conducted in Japan. The aim of this 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:	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 metatropic dysplasia mucopolysaccharidosis type IV pseudoachondroplasia
Drug Information available for: Somatropin
U.S. FDA Resources 

Further study details as provided by Novo Nordisk:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	May 1997
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 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

Genders Eligible for Study:  	Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435629

Locations
Japan
Tokyo, Japan, 103
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director:	Global Clinical Registry (GCR, 1452)	Novo Nordisk Pharma Ltd.
  More Information

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

No publications provided 

Responsible Party:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT01435629     History of Changes
Other Study ID Numbers:	GH-3907, U1111-1121-7729, JapicCTI-111622
Study First Received:	September 14, 2011
Last Updated:	September 16, 2013
Health Authority:	Japan: Ministry of Health, Labour and Welfare (MHLW)

Additional relevant MeSH terms:
Achondroplasia
Genetic Diseases, Inborn
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Osteochondrodysplasias

ClinicalTrials.gov processed this record on November 22, 2013