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

NCT00191074 | Completed Phase 3

• 2 other identifiers: 843B9R-MC-GDCH
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Growth Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Not applicable for Amendment (g).

Interventions

somatropin, rDNA origin, for injection DRUG

Eligibility Criteria

• Age: 9 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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, 20892, United States

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Growth Disorders

Interventions

Human Growth Hormone; WW Domain-Containing Oxidoreductase

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: February 1, 2001
• Study Completion: January 1, 2006
• Last Updated: March 9, 2007

Record last verified: 2007-03

Locations

US (1)