To evaluate in boys and girls the improvement in body composition under GH treatment in adolescents with CO-GHD who remain partially GHD after GH discontinuation.
- Males or females : Chronological age > or = 15 years and
- Chronological age > or = 17 years and
- GHD of childhood onset treated for at least 2 years
- Last GH injection at least 12 months before baseline visit
- Turner's syndrome
- Chronic hepatic impairment as shown by GGT and / or ASAT and / or ALAT > 2 X ULN
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Transition Study: Growth Hormone Therapy In Partial Growth Hormone Deficient Adolescents | |||
| Official Title ICMJE | GH Therapy in Partial GHD Adolescents : Evaluation of Efficacy Based on Body Composition and Comparison of 2 Different Doses of Genotonorm®. Open-Label, Randomised, Comparative, Controlled, Parallel-Group, Multi-Center Phase IIIB Clinical Trial. | |||
| Brief Summary | To evaluate in boys and girls the improvement in body composition under GH treatment in adolescents with CO-GHD who remain partially GHD after GH discontinuation. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Growth Hormone Deficiency | |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
| * 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 | 90 | |||
| Original Enrollment ICMJE | Same as current | |||
| Study Completion Date ICMJE | April 2005 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 15 Years to 20 Years (Child, Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Not Provided | |||
| Removed Location Countries | France | |||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00156143 | |||
| Other Study ID Numbers ICMJE | 307-MET-9002-016 A6281018 | |||
| 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 | July 2007 | |||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
