Growth Hormone Treatment in Short Children Born Small for Gestational Age

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2007-06-30

Brief Summary

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

Detailed Description

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Conditions

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Infant, Small for Gestational Age

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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somatropin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_CHAIR

Eli Lilly and Company

Locations

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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

Site Status

Countries

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Germany

References

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Jung H, Land C, Nicolay C, De Schepper J, Blum WF, Schonau E. Growth response to an individualized versus fixed dose GH treatment in short children born small for gestational age: the OPTIMA study. Eur J Endocrinol. 2009 Feb;160(2):149-56. doi: 10.1530/EJE-08-0301. Epub 2008 Nov 27.

Reference Type DERIVED

PMID: 19039085 (View on PubMed)

Other Identifiers

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B9R-EW-GDGB

Identifier Type: -

Identifier Source: secondary_id

6581