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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191074
First received: September 12, 2005
Last updated: March 7, 2007
Last verified: March 2007
  Purpose

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.


Condition Intervention Phase
Growth Disorder
Drug: somatropin, rDNA origin, for injection
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study of Humatrope in Non-Growth Hormone Deficient Children With Short Stature

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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:
  • Not applicable for Amendment (g).

Estimated Enrollment: 11
Study Start Date: February 2001
Estimated Study Completion Date: January 2006
  Eligibility

Ages Eligible for Study:   9 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00191074

Locations
United States, Maryland
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, 20892
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00191074     History of Changes
Other Study ID Numbers: 843, B9R-MC-GDCH
Study First Received: September 12, 2005
Last Updated: March 7, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dwarfism
Growth Disorders
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014