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

Phase 3

Completed

• Conditions: Growth Disorder

• Registration Number: NCT00191074
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-02
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2006-01
• Status Verified: 2007-03
• Last Update Submitted: 2007-03-07
• Last Update Posted: 2007-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Not applicable for Amendment (g).

Trial Locations

Locations (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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇺🇸 Bethesda, Maryland, United States