Online Surveillance of Treatment of Children With Growth Hormone Deficiency With ZOMACTON
This study is enrolling participants by invitation only.
Sponsor:
Ferring Pharmaceuticals
Collaborator:
Ferring Arzneimittel GmbH
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01365351
First received: June 1, 2011
Last updated: April 23, 2013
Last verified: April 2013
| Tracking Information | |||||
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| First Received Date ICMJE | June 1, 2011 | ||||
| Last Updated Date | April 23, 2013 | ||||
| Start Date ICMJE | November 2007 | ||||
| Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Efficacy of ZOMACTON [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ] measured by: body height, increase of body height per annum |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01365351 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Online Surveillance of Treatment of Children With Growth Hormone Deficiency With ZOMACTON | ||||
| Official Title ICMJE | Non-interventional Study With ZOMACTON in Children With Growth Hormone Deficiency | ||||
| Brief Summary | The purpose of this study is to investigate long-term treatment with Zomacton® for pituitary short stature in children with insufficient growth hormone production and/or short stature caused by Turner syndrome. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Clinics and private practices |
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| Condition ICMJE | Growth Hormone Deficiency | ||||
| Intervention ICMJE | Other: Growth hormone
Drug given by prescription |
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| Study Group/Cohort (s) | Growth hormone
Children with growth hormone deficiency
Intervention: Other: Growth hormone |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 400 | ||||
| Estimated Completion Date | December 2014 | ||||
| Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01365351 | ||||
| Other Study ID Numbers ICMJE | ZOM/011207/03 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Ferring Pharmaceuticals | ||||
| Study Sponsor ICMJE | Ferring Pharmaceuticals | ||||
| Collaborators ICMJE | Ferring Arzneimittel GmbH | ||||
| Investigators ICMJE |
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| Information Provided By | Ferring Pharmaceuticals | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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