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Trial · Interventional

CompletedPhase 4Registry data

Short Stature Related Distress

NCTNCT01246219 (opens ClinicalTrials.gov in a new tab)Other idrmc004981ctil
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Overview

Status
Completed
Phase
Phase 4
Enrollment
60 participants (actual)
Sponsor
Rabin Medical Center · Other
Design
Randomized · Triple masking
Countries
1 country

Israel

Start
Oct 2011
Primary completion
Nov 2017
Completion
Nov 2017
First posted
23 Nov 2010 (estimated)
Last update posted
20 Dec 2017
Conditions
Idiopathic Short Stature · Self Image

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201420162018
  1. Ph 4

    Short Stature Related Distress

    NCT01246219

    Oct 2011 to Nov 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • GH treatment (Genotropin)Drug
  • 1 year treatment with placebo followed by optional 3 years of GH treatmentDrug

Arms3

  • Experimental

    GH treatment

    4 years of GH treatment

  • Placebo comparator

    Placebo

    1 year treatment with placebo followed by optional 3 years of GH treatment

  • No intervention

    Non treatment group

Primary outcomes4

Outcomes the sponsor listed as primary.

  1. Psychological Distress score

    Time frame · After 4 years of treatment

    Registry description

    short stature related distress score as measured by the Height Perception Pictures Test

  2. Psychological Distress score

    Time frame · After 4 years of treatment

    Registry description

    short stature related distress score as measured by the Rosenberg Self-Esteem Scale

  3. Psychological Distress score

    Time frame · After 4 years of treatment

    Registry description

    short stature related distress score as measured by the Quality of Life questionnaire

  4. Psychological Distress score

    Time frame · After 4 years of treatment

    Registry description

    short stature related distress score as measured by Silhouette Apperception Technique questionnaire

Secondary outcomes(2)

  1. Perceived self image score

    Time frame · After 4 years of treatment

    Registry description

    Perceived self image score as measured through Single Category Implicit Association Test

  2. Perceived self image score

    Time frame · After 4 years of treatment

    Registry description

    Perceived self image score as measured through the Masculine Self Image questionnaire

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2019

Growth hormone therapy and short stature-related distress: A randomized placebo-controlled trial.

Shemesh-Iron et al. 2019Clinical endocrinologycited by 8

PMID 30721549DOI 10.1111/cen.13944PUB-30721549

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Male
Age
from 8 Years up to 17 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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