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Trial · Interventional

CompletedPhase 4Registry data

Growth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation

NCTNCT01697644 (opens ClinicalTrials.gov in a new tab)Other idGHRETARD/NL/21
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
75 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
1 country

Netherlands

Start
Oct 1990
Primary completion
May 2005
Completion
May 2005
First posted
2 Oct 2012 (estimated)
Last update posted
18 Jan 2017 (estimated)
Conditions
Foetal Growth Problem · Small for Gestational Age

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
1990199520002005
  1. Ph 4

    Growth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation

    NCT01697644

    Oct 1990 to May 2005

Registry summary

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

This trial is conducted in Europe. The aim of this trial is to assess and compare the efficacy and safety of two dose levels of somatropin over a long period (till final height is reached). This trial is an extension to trials GHRETARD/BDP/14/NL (a 2-year initial trial) and GHRETARD/BPD/20/NL (a 2-year extension trial).

Interventions

  • somatropinDrug
  • somatropinDrug

Arms2

  • Experimental

    Low dose

  • Experimental

    High dose

Primary outcomes4

Outcomes the sponsor listed as primary.

  1. Linear growth (height during childhood)

  2. Final height

  3. Bone maturation

  4. Pubertal development

Secondary outcomes(1)

  1. Adverse events

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

Studies4

Studies that cite this trial.

Studies with results

4 studies on this page

Indexing hint: Randomized controlled trial · 2003

12 results

Adult height after long-term, continuous growth hormone (GH) treatment in short children born small for gestational age: results of a randomized, double-blind, dose-response GH trial.

Van Pareren et al. 2003The Journal of clinical endocrinology and metabolismcited by 176

PMID 12915640DOI 10.1210/jc.2002-021172PUB-12915640

Full text at the publisher12 results
Publisher pageSee results (12)

Indexing hint: Randomized controlled trial · 2001

13 results

Carbohydrate metabolism during long-term growth hormone treatment in children with short stature born small for gestational age.

Sas et al. 2001Clinical endocrinologycited by 60

PMID 11207640DOI 10.1046/j.1365-2265.2001.01178.xPUB-11207640

Full text at the publisher13 results
Publisher pageSee results (13)

Indexing hint: Randomized controlled trial · 2000

8 results

Body composition, blood pressure, and lipid metabolism before and during long-term growth hormone (GH) treatment in children with short stature born small for gestational age either with or without GH deficiency.

Sas et al. 2000The Journal of clinical endocrinology and metabolismcited by 91

PMID 11061539DOI 10.1210/jcem.85.10.6917PUB-11061539

Rights unknown8 results
Source linkSee results (8)

Indexing hint: Randomized controlled trial · 1999

9 results

Growth hormone treatment in children with short stature born small for gestational age: 5-year results of a randomized, double-blind, dose-response trial.

Sas et al. 1999The Journal of clinical endocrinology and metabolismcited by 141

PMID 10487666DOI 10.1210/jcem.84.9.5942PUB-10487666

Rights unknown9 results
Source linkSee results (9)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultBoonstra V, van Pareren Y, Mulder P, Hokken-Koelega A. Puberty in growth hormone-treated children born small for gestational age (SGA). J Clin Endocrinol Metab. 2003 Dec;88(12):5753-8. doi: 10.1210/jc.2003-030512. PMID 14671164
  • ResultSas TC, Gerver WJ, De Bruin R, Mulder PG, Cole TJ, De Waal W, Hokken-Koelega AC. Body proportions during 6 years of GH treatment in children with short stature born small for gestational age participating in a randomised, double-blind, dose-response trial. Clin Endocrinol (Oxf). 2000 Dec;53(6):675-81. doi: 10.1046/j.1365-2265.2000.01155.x. PMID 11155088
  • Resultvan Pareren Y, Mulder P, Houdijk M, Jansen M, Reeser M, Hokken-Koelega A. Effect of discontinuation of growth hormone treatment on risk factors for cardiovascular disease in adolescents born small for gestational age. J Clin Endocrinol Metab. 2003 Jan;88(1):347-53. doi: 10.1210/jc.2002-020458. PMID 12519875

Eligibility

Who could join, as posted.

Sex
All
Age
from 3 Years up to 11 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Completion of the GHRETARD/BPD/20/NL trial * Written informed consent from child and/or parents/guardians before continuation in the extension trial

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