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OpenTrials
Completed

NCT Number: NCT00191529

Growth Hormone Treatment in Short Children Born Small for Gestational Age

Comparison of 2 different doses of human growth hormone treatment on change in height after 1 and 2 years of treatment.

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Key information

Conditions

Infant, Small for Gestational Age

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Cologne, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Born small for gestational age
  • actual body height less than or equal -3 SDS
  • chronological age greater than 3 years

Exclusion criteria

  • Growth hormone deficiency
  • any defined syndromal disease
  • Diabetes mellitus

Treatment and study plan

Somatropin

Drug

Primary outcomes

  1. The 2 different doses used are non-inferior to each other

Secondary outcomes

  1. Safety profiles

  2. Compare absolute height velocity

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Optimization of Growth Hormone Treatment in Short Children Born Small for Gestational Age Based on a Growth Prediction Model-The OPTIMA Trial

Important dates

Study start
2002
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
Jun 15, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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