Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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 A/S
ClinicalTrials.gov Identifier:
NCT01435629
First received: September 14, 2011
Last updated: January 12, 2015
Last verified: August 2014
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: 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 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 ] [ 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
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
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
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 A/S
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: January 12, 2015
Health Authority: Japan: Ministry of Health, Labour and Welfare (MHLW)

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

ClinicalTrials.gov processed this record on February 25, 2015