NCT00191529

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2002

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

June 15, 2007

Status Verified

June 1, 2007

First QC Date

September 12, 2005

Last Update Submit

June 13, 2007

Conditions

Infant, Small for Gestational Age

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • Safety profiles

  • Compare absolute height velocity

Interventions

somatropinDRUG

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Location

Related Publications (1)

  • 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.

    PMID: 19039085DERIVED

Related Links

MeSH Terms

Interventions

Human Growth Hormone

Intervention Hierarchy (Ancestors)

Growth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

December 1, 2002

Study Completion

June 1, 2007

Last Updated

June 15, 2007

Record last verified: 2007-06

Locations

DE(1)