Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary
NCT00174278
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Adult Trials: 18+ Years
- All the patients who have benefit during one year of a treatment by Genotonorm during the study 94-8123-014
- All patients who have stopped during one year will be included if a signed written informed consent
- Endocrine disease, except well substituted hypothyroidism
- Other severe chronic diseases (e.g. diabetes mellitus, cardiac or liver insufficiency)
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary | |||
| Official Title ICMJE | Treatment With Recombinant Human Growth Hormone (Genotonorm®) In Children With Short Stature Secondary To A Long Term Corticoid Therapy. A Study of Efficacy and Safety. | |||
| Brief Summary | To assess the effect of long-term treatment by Genotonorm on linear growth | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE |
| |||
| Intervention ICMJE | Drug: Somatropin | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | David H, Aupiais C, Louveau B, Quartier P, Jacqz-Aigrain E, Carel JC, Simon D. Growth Outcomes After GH Therapy of Patients Given Long-Term Corticosteroids for Juvenile Idiopathic Arthritis. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4578-4587. doi: 10.1210/jc.2017-01455. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 14 | |||
| Original Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | October 2006 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 6 Years and older (Child, Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | France | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00174278 | |||
| Other Study ID Numbers ICMJE | 96-8123-018 A6281217 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | August 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||