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

NCT00191074 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2007-03-09

No results posted yet for this study

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.

Conditions

  • Growth Disorder

Interventions

DRUG

somatropin, rDNA origin, for injection

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
9 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-02-28
Completion
2006-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00191074 on ClinicalTrials.gov