Short Stature Related Distress

NCT01246219

Last updated date
Study Location
Schneider Children's Medical center
Petach-Tikva, , 49202, Israel
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Idiopathic Short Stature, Self Image
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
8-17 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1 Segment 1 :Boys at the age range of 8-13 years 2. Segment 2: Boys at the age range of 12-17 years 3. Tanner stage 1 (segment 1 only) 4. more than 2 SD's (standard deviation) below the average height

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Mental retardation,


2. Psychiatric illness,


3. Lack of informed consent\assent.


4. Health status that required chronic treatment with steroids

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Idiopathic Short Stature, Self ImageShort Stature Related Distress
NCT01246219
  1. Petach-Tikva,
Male
8 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Short Stature Related Distress
Official Title  ICMJE The Influence of Growth Hormone (GH) Therapy on Short Stature Related Distress a Prospective Randomized Controlled Trial
Brief Summary The research aims to provide data on gender-related psychological impact of GH (Growth Hormone)treatment. Implicit measurable psychological metrics of the therapy outcome on males are to be evaluated in a Prospective Randomized Controlled Trial. As a secondary axis of the study, the investigators aim to provide descriptive documentation of the unique distress signal manifestation implicitly shown by Idiopathic Short Stature (ISS) boys and suggest methods of early detection and measurement of such manifestations that can be used to cement guidelines for the treatment in GH.
Detailed Description

Study Design:

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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Idiopathic Short Stature
  • Self Image
Intervention  ICMJE
  • Drug: GH treatment (Genotropin)
    4 years treatment with GH
  • Drug: 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
Study Arms  ICMJE
  • Experimental: GH treatment
    4 years of GH treatment
    Intervention: Drug: GH treatment (Genotropin)
  • Placebo Comparator: Placebo
    1 year treatment with placebo followed by optional 3 years of GH treatment
    Intervention: Drug: 1 year treatment with placebo followed by optional 3 years of GH treatment
  • No Intervention: Non treatment group
Publications * 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.

*   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
 (submitted: December 18, 2017)
60
Original Estimated Enrollment  ICMJE
 (submitted: November 22, 2010)
120
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1 Segment 1 :Boys at the age range of 8-13 years 2. Segment 2: Boys at the age range of 12-17 years 3. Tanner stage 1 (segment 1 only) 4. more than 2 SD's (standard deviation) below the average height

Exclusion Criteria:

  1. Mental retardation,
  2. Psychiatric illness,
  3. Lack of informed consent\assent.
  4. Health status that required chronic treatment with steroids
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 8 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01246219
Other Study ID Numbers  ICMJE rmc004981ctil
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Moshe Phillip, ProfRabin Medical Center
PRS Account Rabin Medical Center
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP