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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191165
First received: September 12, 2005
Last updated: June 8, 2009
Last verified: June 2009

September 12, 2005
June 8, 2009
March 2004
April 2008   (final data collection date for primary outcome measure)
Height Velocity Standard Deviation Score (SDS) at 12-Month Endpoint [ Time Frame: 12-Months ] [ Designated as safety issue: No ]
test that 1y treat, h.velocity SDS of early pubertal subj with GHD rec hGH repl ther with a dd from 0.05 to 0.07 mg/kg/d is signif greater than that of subj rec hGH repl ther with an inlabel dose from 0.025 to 0.035 mg/kg/d
Complete list of historical versions of study NCT00191165 on ClinicalTrials.gov Archive Site
  • Change From Baseline to 12-Month and 24-Month Endpoints in Height Standard Deviation Score (SDS) [ Time Frame: Baseline, 12-Months, 24-Months ] [ Designated as safety issue: No ]
  • Height Velocity Standard Deviation Score (SDS) at 24 Month Endpoint [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
  • test that 1y treat, 2ndy h.velocity SDS of early pubertal subj with GHD who rec hGH repl ther with a dd from 0.05 to 0.07 mg/kg/d is significantly greater than that of similar subj who rec somatropin repl ther with an in-label dose
  • from 0.025 to 0.035 mg/
Not Provided
Not Provided
 
Efficacy and Safety of a High Dosage Compared to the Label Dosage of Somatropin in Early Pubertal Stage Children With Growth Hormone Deficiency
Efficacy and Safety of a High Dosage Compared to the Label Dosage of Humatrope in Early Pubertal Stage Children With Growth Hormone Deficiency

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Growth Hormone Deficiency
  • Drug: Somatropin
    Doubled dosage with respect to the pre-enrollment (in-label) dosage
    Other Names:
    • LY137998
    • Humatrope
  • Drug: Somatropin
    In-label dosage
    Other Names:
    • LY137998
    • Humatrope
  • Experimental: 1
    Doubled dosage
    Intervention: Drug: Somatropin
  • Active Comparator: 2
    In-label dosage
    Intervention: Drug: Somatropin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
April 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Both
up to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00191165
5202, B9R-IT-GDFU
No
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
Study Chair: 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
Eli Lilly and Company
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP