Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature (Phoenix)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00355030
First received: July 18, 2006
Last updated: August 6, 2015
Last verified: August 2015
  Purpose

The present randomized trial was initially intended to study the benefits of a combined treatment with growth hormone (GH) and a gonadotropin-releasing hormone (GnRH) agonist for pubertal children with idiopathic short stature. However, treatments were stopped in January 2012 at the request of the French drug agency. Therefore, a protocol amendment divided the study in two study periods.

Study Period 1 involved combined treatment with somatropin and leuprorelin or treatment with somatropin alone. Participants from France who participated in this Period 1 of the study were asked to participate in a long term safety follow up defined as a Period 2 of the study, which is currently ongoing. Participants from the Netherlands were offered participation in Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS, clinicaltrials.gov Identifier: NCT01088412) for long term safety follow up independent of this study.


Condition Intervention Phase
Idiopathic Short Stature (ISS)
Drug: somatropin
Drug: leuprorelin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Somatropin in Combination With Leuprorelin Compared to Somatropin Alone in Pubertal Children With Idiopathic Short Stature

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of Participants with one or more drug-related adverse events [ Time Frame: Baseline through End of Study (up to 9 years) ] [ Designated as safety issue: No ]
  • Adult height standard deviation score (SDS) [ Time Frame: Up to 9 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Height velocity [ Time Frame: Up to 9 Years ] [ Designated as safety issue: No ]
  • Height SDS [ Time Frame: Up to 9 Years ] [ Designated as safety issue: No ]
  • Difference between adult height SDS and target height SDS [ Time Frame: Up to 9 Years ] [ Designated as safety issue: No ]
  • Difference between adult height SDS and baseline predicted height SDS [ Time Frame: Baseline, End up Study (up to 9 years) ] [ Designated as safety issue: No ]
  • Difference between adult height SDS and baseline height SDS [ Time Frame: Baseline, End up Study (up to 9 years) ] [ Designated as safety issue: No ]
  • Proportion of children with normal adult height SDS [ Time Frame: Up to 9 Years ] [ Designated as safety issue: No ]
  • Bone age [ Time Frame: Up to 9 Years ] [ Designated as safety issue: No ]

Enrollment: 94
Study Start Date: June 2006
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: somatropin
0.05 mg/kg/day
Other Names:
  • LY137998
  • Humatrope
Drug: leuprorelin
11.25 mg/3 months
Experimental: 2 Drug: somatropin
0.05 mg/kg/day
Other Names:
  • LY137998
  • Humatrope

  Eligibility

Ages Eligible for Study:   8 Years to 171 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female children with ISS
  • age greater than or equal to 8 years and less than or equal to 12 years and 3 months for girls and greater than or equal to 9 years and less than or equal to 14 years and 3 months for boys
  • bone age less than or equal to 12.0 years for girls and less than or equal to 14.0 years for boys based on a central reading of an X-ray of the left hand and wrist
  • Pubertal stage B2 and B3 for girls based on the Tanner method
  • Pubertal stage G2 and G3 for boys based on the Tanner method

Exclusion Criteria:

  • Growth hormone deficiency (GHD)
  • Insulin-like growth factor-I levels greater than 3 SDS
  • Chromosomal abnormality diagnosed locally on a karyotype. For girls, the karyotype to eliminate a Turner syndrome, is mandatory
  • Small for gestational age (SGA)
  • Has reached menarche (had her first menstrual period)
  • Have any significant concomitant disease that is likely to interfere with growth or with the study, or is a known contraindication to Growth Hormone treatment
  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: NCT00355030

Locations
France
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.
Amiens, France, 80084
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.
Besancon, France, 25030
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.
Bordeaux, France, 33076
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.
Boulogne, France, 92100
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.
Le Havre, France, 76083
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Lille, France, 59037
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Lyon, France, 69322
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Marseille, France, 13385
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Nice, France, 06200
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Paris, France, 75743
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.
Reims, France, 51092
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.
Rennes, France, 35056
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.
Rouen, France, 76036
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.
Saint-Etienne, France, 42055
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Strasbourg, France, 67 098
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.
Tarbes, France, 65000
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.
Toulouse, France, 31026
Netherlands
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.
Nijmegen, Netherlands, 6525 GM
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.
Rotterdam, Netherlands, 3015 GD
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00355030     History of Changes
Other Study ID Numbers: 9861, B9R-FP-GDGI
Study First Received: July 18, 2006
Last Updated: August 6, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Dwarfism
Bone Diseases
Bone Diseases, Developmental
Endocrine System Diseases
Genetic Diseases, Inborn
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 03, 2015