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Trial record 4 of 6 for:    "Achondroplasia"
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A Survey Collecting Data on Adult Height in Patients With Achondroplasia Treated With Somatropin

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01435629
First received: September 14, 2011
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
  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:

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: Masayuki Senda 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: April 15, 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 June 18, 2013