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Long Term Effect of Somatropin in Subjects With Intrauterine Growth Retardation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01734447
First received: November 22, 2012
Last updated: February 27, 2017
Last verified: February 2017
  Purpose
This trial is conducted in Europe. The aim of this trial is to assess the safety of long-term growth hormone treatment in growth-retarded children with intrauterine growth retardation (IUGR) enrolled in trial GHRETARD/F/1/F.

Condition Intervention Phase
Foetal Growth Problem Small for Gestational Age Drug: somatropin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Discontinued Administration (6 Months a Year) of Growth Hormone to Children With Very Short Stature and Having Suffered From Intrauterine Growth Retardation: Safety and Effect on Growth of Long-term Therapy

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Glucose tolerance as assessed by hyperglycaemia induced by oral ingestion

Secondary Outcome Measures:
  • Bone Age determined according to Greulich and Pyle method and measured on the left hand X-ray
  • Pubertal development, assessed according to Tanner method
  • Height velocity
  • Final height
  • Number of Adverse Events

Enrollment: 57
Actual Study Start Date: April 30, 2000
Study Completion Date: April 30, 2003
Primary Completion Date: April 30, 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1.2, continuous treatment Drug: somatropin
1.2 IU/kg/week, one injection per day, in six days out of seven days, for 12 months
Experimental: 1.2, non-continuous treatment Drug: somatropin
1.2 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively)
Experimental: 2.4, non-continuous treatment Drug: somatropin
2.4 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively)

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients born with IUGR enrolled in trial GHRETARD/F/1/F
  • Bone age below 14 years in boys and 12 years in girls

Exclusion Criteria:

  • Bone age above 14 years in boys and 12 years in girls
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01734447

Locations
France
Novo Nordisk Investigational Site
Paris, France
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01734447     History of Changes
Other Study ID Numbers: GHRETARD/F/2/F
Study First Received: November 22, 2012
Last Updated: February 27, 2017

Additional relevant MeSH terms:
Fetal Growth Retardation
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on June 23, 2017