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Clinical Trials/NCT00557336
NCT00557336CompletedPhase 3

Evaluation of Efficacy and Safety of Somatropin in SGA Children Due to IUGR

Novo Nordisk A/S38 sites in 1 country160 target enrollmentStarted: July 28, 2003Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
160
Locations
38
Primary Endpoint
Height gain according to birth group, age of onset, the treatment and Tanner stage
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This trial is conducted in Europe. The aim of this clinical trial is to evaluate the height gain during 12 months of growth hormone treatment in children born small for gestational age due to intrauterine growth retardation.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
2 Years to 14 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Born small for gestational age (SGA) due to intrauterine growth retardation (IUGR) defined as birth length and/or weight below P10
  • •Chronological age at least 4 years old until bone age maturation of maximum 12 years for girls and maximum 13,5 for boys at time of inclusion in the study
  • •Insufficient catch-up growth (height lesser than or equal to -2.5 SDS for chronological age
  • •Normal response to GH stimulation test (greater than 10 ng/mL)

Exclusion Criteria

  • •Growth retardation associated with infections severe chronic diseases (including chromosomal anomaly or nutritional disorders)
  • •Treatment with any medical product (anabolic drugs, sex steroids, etc.) which may interfere with GH effects
  • •History or presence of severe disease that could interfere with GH treatment/participation in the trial, e.g. active malignancy
  • •Previous or ongoing growth hormone therapy

Outcomes

Primary Outcomes

Height gain according to birth group, age of onset, the treatment and Tanner stage

Time Frame: during 12 months of treatment

Secondary Outcomes

  • Height SDS for bone age(during 12 months of treatment)
  • Height velocity SDS for bone age(during 12 months of treatment)
  • Height velocity for chronological age(during 12 months of treatment)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (38)

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