Individualizing Dose of Growth Hormone to Maintain Normal Growth Velocity After Fulfilled Catch up Growth in Children
NCT02879747
Last updated date
ABOUT THIS STUDY
The objective was to study whether normal growth velocity can be maintained with adapted GH
dosage in GH treated prepubertal children who have responded to GH treatment with fulfilled
catch up growth (=difference to target height reached, less than - 0.6 SDS).
FOR MORE INFORMATION
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Short Stature
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
4-18 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Participated in the 'GH-dose catch-up study' 98- 0198-003.
- Midparental height reached (difference less than 0.6 SDS)
- Prepubertal at start of the study (girls =B 1, boys: testes :<; 3ml).
- Signed written informed consent from the patient's parents (and the child if old enough)
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Disease affecting growth other than correctly treated hypothyroidism.
- Incapable of following the study protocol (i.e. bad compliance in the previous study).
- Puberty (> breast stage 2, or testes > 4ml).
- Poor compliance.
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Short StatureIndividualizing Dose of Growth Hormone to Maintain Normal Growth Velocity After Fulfilled Catch up Growth in Children
NCT02879747
ALL GENDERS
4 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||||||||||||||
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| Brief Title ICMJE | Individualizing Dose of Growth Hormone to Maintain Normal Growth Velocity After Fulfilled Catch up Growth in Children | |||||||||||||||
| Official Title ICMJE | Individualizing the Dose of Growth Hormone (GH) to Maintain Normal Growth Velocity After Fulfilled Catch up Growth in Children Within TR 98-0198-003 | |||||||||||||||
| Brief Summary | The objective was to study whether normal growth velocity can be maintained with adapted GH dosage in GH treated prepubertal children who have responded to GH treatment with fulfilled catch up growth (=difference to target height reached, less than - 0.6 SDS). | |||||||||||||||
| Detailed Description | The aim of the trial is to study the effect of adapted GH treatment in order to find an individualized GH dose maintaining normal growth velocity close to target height SDS and normal metabolism after fulfilled catch up growth in prepubertal children treated with individual doses of GH within the trial 98-0198-003 (1). The overall aim is to find for the individual the lowest effective GH dose during maintenance period, maintaining normal growth velocity and metabolism, i.e. a satisfactory biological active dose. | |||||||||||||||
| Study Type ICMJE | Interventional | |||||||||||||||
| Study Phase ICMJE | Phase 2 Phase 3 | |||||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||||||||||||||
| Condition ICMJE | Short Stature | |||||||||||||||
| Intervention ICMJE | Drug: Genotropin
Children were randomized to either decreased dose by 50% or unchanged dose after 2-3 years of Catch-up growth | |||||||||||||||
| Study Arms ICMJE |
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| Publications * |
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* 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 | |||||||||||||||
| Actual Enrollment ICMJE | 99 | |||||||||||||||
| Original Actual Enrollment ICMJE | Same as current | |||||||||||||||
| Actual Study Completion Date ICMJE | December 2017 | |||||||||||||||
| Actual Primary Completion Date | March 2012 (Final data collection date for primary outcome measure) | |||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 4 Years to 18 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 | ||||||||||||||||
| Administrative Information | ||||||||||||||||
| NCT Number ICMJE | NCT02879747 | |||||||||||||||
| Other Study ID Numbers ICMJE | NRA 6280003 | |||||||||||||||
| Has Data Monitoring Committee | Yes | |||||||||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||
| Responsible Party | Göteborg University | |||||||||||||||
| Study Sponsor ICMJE | Göteborg University | |||||||||||||||
| Collaborators ICMJE | Pfizer | |||||||||||||||
| Investigators ICMJE |
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| PRS Account | Göteborg University | |||||||||||||||
| Verification Date | April 2019 | |||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||||||||||||||