Brief Summary

Multi-center, randomized, controlled, open-label, phase III study comparing the effects of two different dosages of somatropin treatment (in-label or doubled) after 12 and 24 months of treatment, on height velocity in early pubertal children with growth hormone deficiency (GHD). The study will be conducted in Italy. Approximately 26 subjects will participate in this study, distributed as 13 in the in-label dosage group (group A) and 13 in the doubled dosage group (group B).

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Mar 2004

Typical duration for phase_3

Geographic Reach

1 country

10 active sites

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

4.1 years study duration

Study Start

First participant enrolled

March 1, 2004

Completed

1.5 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

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

June 8, 2009

Completed

Last Updated

June 10, 2009

Status Verified

June 1, 2009

Enrollment Period

4.1 years

First QC Date

September 12, 2005

Results QC Date

April 7, 2009

Last Update Submit

June 8, 2009

Conditions

Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

Height Velocity Standard Deviation Score (SDS) at 12-Month Endpoint
Height velocity (difference between 2 height measurements, divided by years elapsed between measurements) SDS was derived by subtracting age and gender-matched population mean height velocity from patient's height velocity (based on measurements 12 months apart) then dividing this value by age and gender-matched population height velocity SD.
12-Months

Secondary Outcomes (2)

Change From Baseline to 12-Month and 24-Month Endpoints in Height Standard Deviation Score (SDS)
Baseline, 12-Months, 24-Months
Height Velocity Standard Deviation Score (SDS) at 24 Month Endpoint
24 Months

Study Arms (2)

1

EXPERIMENTAL

Doubled dosage

Drug: Somatropin

2

ACTIVE COMPARATOR

In-label dosage

Drug: Somatropin

Interventions

SomatropinDRUG

Doubled dosage with respect to the pre-enrollment (in-label) dosage

Also known as: LY137998, Humatrope

Eligibility Criteria

AgeUp to 14 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Height velocity (cm/y) less than 25th percentile at the time of diagnosis.
diagnosis of GHD
Replacement therapy at label dosage (from 0.025 to 0.035 mg/kg/day) must be started at least 1 year before the enrolment in this study, but at most 3 years before enrolment
Bone age less than 12 years for girls and less than 14 years for boys. This assessment should be made by the central reader of bone ages, based on the x-ray taken at Visit 0.
Informed consent obtained from either both of the subject's parents or legal representative.

You may not qualify if:

Pubertal clinical stage less than 2 and greater than 3 according to Tanner score (for male subjects a volume of testicle greater than 15 mL).
Any evidence of active malignancy. In case of previous surgical removal of both diencephalic and hypophysial masses, an MRI, performed within six months before enrollment into the study, must exclude the growth of residual tumoral tissue.
Any known chronic disease such as diabetes mellitus, hepatic disease (defined by elevated liver enzymes 3-fold the upper limit of normal ranges), renal disease with creatinine levels greater than 130 micromol/L, or congestive heart failure.
Glucocorticoid therapy in supra physiological doses (inhaled corticoids will be accepted if below 3 puffs/day, for no more than 10 days consecutively).
Current or previous therapy with any therapy that may directly influence growth, including growth hormone releasing hormone, estrogens and anabolic steroids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (10)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Bari, Italy

Location

Bologna, Italy

Location

Catania, Italy

Location

Milan, Italy

Location

Novara, Italy

Location

Parma, Italy

Location

Pavia, Italy

Location

Pisa, Italy

Location

Torino, Italy

Location

Verona, Italy

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Human Growth HormoneGrowth Hormone

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

Call 1-877-CTLILLY (1-877-285-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

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

March 1, 2004

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

June 10, 2009

Results First Posted

June 8, 2009

Record last verified: 2009-06

Locations

IT(10)

Efficacy and Safety of a High Dosage Compared to the Label Dosage of Somatropin in Early Pubertal Stage Children With Growth Hormone Deficiency

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (10)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (10)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations