A Survey Collecting Data on Adult Height in Patients With Achondroplasia Treated With Somatropin
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ClinicalTrials.gov Identifier: NCT01435629 |
Recruitment Status :
Completed
First Posted : September 16, 2011
Last Update Posted : May 5, 2017
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Condition or disease | Intervention/treatment |
---|---|
Genetic Disorder Achondroplasia | Drug: somatropin |
Study Type : | Observational |
Actual Enrollment : | 81 participants |
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] |
Actual Study Start Date : | November 22, 2012 |
Actual Primary Completion Date : | December 4, 2015 |
Actual Study Completion Date : | December 4, 2015 |

Group/Cohort | Intervention/treatment |
---|---|
Norditropin® |
Drug: somatropin
Dosage and administration to be prescribed by the physician as a result of a normal clinical practice. |
- 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 ]
- 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 ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01435629
Japan | |
Novo Nordisk Investigational Site | |
Tokyo, Japan, 1000005 |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT01435629 |
Other Study ID Numbers: |
GH-3907 U1111-1121-7729 ( Other Identifier: WHO ) JapicCTI-111622 ( Other Identifier: JAPIC ) |
First Posted: | September 16, 2011 Key Record Dates |
Last Update Posted: | May 5, 2017 |
Last Verified: | May 2017 |
Achondroplasia Genetic Diseases, Inborn Dwarfism Bone Diseases, Developmental |
Bone Diseases Musculoskeletal Diseases Osteochondrodysplasias |