Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2011-10-31
2017-11-30
Brief Summary
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Detailed Description
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A prospective randomized, double blind, placebo controlled trial design, comparing four research groups, with 4 repeated psychological measures (before treatment, after 3 months,after 1 year, and at the end of treatment, after 4 years).
The study will be divided into two segments:
Segment 1:double blind, placebo controlled, will include the first 60 ISS (Idiopathic Short Stature)recruited patients. Patients in this segment will be randomized to one of the growth hormone treatment groups in a ratio of 2:1. 40 patients will be treated 4 years with GH and 20 patients will be treated with placebo at the first year of the study and will have the option to start GH treatment after one year, for a duration of 3 years.
Segment 2:after the enrollment to segment 1 will end, enrollment to segment 2 will begin.Participants in segment 2 (patients with ISS and short stature) will serve as control groups and therefore will not be treated with growth hormone. Patients in Segment 2 will be evaluated only once.
The 4 repeated psychological evaluations (before treatment,after 3 months, after 1 year, and at the end of treatment, after 4 years)will include the following:
1. Implicit Association Test
2. Masculine Self Image
3. Pictures Projective Test
4. The Rosenberg Self Esteem Scale-a self report measure of explicit self- esteem
5. Quality of Life Questionnaire
6. Silhouette Apperception Technique (SAT)- a self report measure assessing children's and adolescent's perception of their own body size compared with that of their age-related peers
7. Child Behavior Checklist
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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GH treatment
4 years of GH treatment
GH treatment (Genotropin)
4 years treatment with GH
Placebo
1 year treatment with placebo followed by optional 3 years of GH treatment
1 year treatment with placebo followed by optional 3 years of GH treatment
1 year treatment with placebo followed by optional 3 years of GH treatment
Non treatment group
No interventions assigned to this group
Interventions
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GH treatment (Genotropin)
4 years treatment with GH
1 year treatment with placebo followed by optional 3 years of GH treatment
1 year treatment with placebo followed by optional 3 years of GH treatment
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Psychiatric illness,
3. Lack of informed consent\\assent.
4. Health status that required chronic treatment with steroids
8 Years
17 Years
MALE
No
Sponsors
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Pfizer
INDUSTRY
Rabin Medical Center
OTHER
Responsible Party
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Principal Investigators
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Moshe Phillip, Prof
Role: PRINCIPAL_INVESTIGATOR
Rabin Medical Center
Locations
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Schneider Children's Medical center
Petah Tikva, , Israel
Countries
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References
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Shemesh-Iron M, Lazar L, Lebenthal Y, Nagelberg N, Tenenbaum A, Ezra R, Leffler N, Yackobovitch-Gavan M, Schoenberg-Taz M, Phillip M. Growth hormone therapy and short stature-related distress: A randomized placebo-controlled trial. Clin Endocrinol (Oxf). 2019 May;90(5):690-701. doi: 10.1111/cen.13944. Epub 2019 Mar 7.
Other Identifiers
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rmc004981ctil
Identifier Type: -
Identifier Source: org_study_id