Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature

Phase III Study of Humatrope in Non-Growth Hormone Deficient Children With Short Stature

After approval of amendment (g), patients who were still receiving study drug at the time were scheduled for a study visit. In addition, patients who had discontinued early from the core, blinded phase of the study were contacted.

All of these patients were offered the opportunity to enter the unblinded extension phase (if they met eligibility criteria) and continue somatropin treatment (regardless of initial treatment randomization) until they reached final height.

Study Overview

• Status: Completed
• Conditions: Growth Disorder
• Intervention / Treatment: Drug: somatropin, rDNA origin, for injection

• Study Type: Interventional
• Enrollment: 11
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Participation in core, blinded phase and ability to be contacted by investigators.

For patients who were on treatment at the time of amendment (g), growth velocity greater than or equal to 1.5 cm/year measured over the prior 12-month period. For patients who had chosen to discontinue treatment in the core, blinded phase, bone age less than or equal to 16 years for boys and less than or equal to 14 years for girls.

Exclusion Criteria:

Diabetes mellitus.

History, evidence or signs of active malignancy within 5 years prior to the start of the extension phase.

Any condition or medication that, in the opinion of the investigators, might significantly increase the risk or decrease the efficacy of growth hormone therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Every 6 months: physical exam, pubertal staging, height, weight, and adverse event collection.
Every year: arm span measurements, head circumference measurements, x-ray for bone age, and
laboratory blood draws.

Secondary Outcome Measures

Outcome Measure
Not applicable for Amendment (g).

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

Helpful Links

• Lilly Clinical Trial Registry

Study record dates

Study Major Dates

• Study Start: February 1, 2001
• Study Completion: January 1, 2006

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 19, 2005

Study Record Updates

• Last Update Posted (Estimate): March 9, 2007
• Last Update Submitted That Met QC Criteria: March 7, 2007
• Last Verified: March 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Endocrine System Diseases; Genetic Diseases, Inborn; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Developmental; Growth Disorders; Dwarfism
• Other Study ID Numbers: 843; B9R-MC-GDCH