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Sponsored by: |
EMD Serono |
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Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00109733 |
The primary objective is to evaluate the efficacy and safety of two different dose regimens of r-hGH (Saizen®) in subjects with childhood-onset growth hormone deficiency (COGHD) during the transition phase from childhood to adulthood.
Condition | Intervention | Phase |
---|---|---|
Childhood-Onset Growth Hormone Deficiency Pituitary Dwarfism |
Drug: Saizen® |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Efficacy Study |
Official Title: | A Phase IIIb, Prospective, Multicenter, Randomized, Open-Label Study to Determine the Safety and Efficacy of Two Different Dosing Regimens of Saizen® (Recombinant Human Growth Hormone (r-hGH), Using Cool.Click™ in Subjects With Childhood-Onset Growth Hormone Deficiency During the Adolescent Transition Phase (CATS) |
Estimated Enrollment: | 60 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | July 2006 |
This is a phase IIIb, prospective, multicenter, randomised, open label study to determine the safety and efficacy of two different dose regimens of r-hGH with a dose escalation scheme. Screening assessments must be completed 30 days prior to SD1 (Study Day 1). Eligible subjects ages 13 to 21 years will be randomised in equal allocation in a 1:1 ratio to one of two treatment groups (30 subjects/group). Daily subcutaneous injections will be self-administered or received from a designated individual using cool.click™, the needle-free growth hormone (GH) delivery device. The study consists of three periods: screening (up to 30 days prior to Study Day 1), active treatment (up to 24 weeks), and follow-up (4 week safety evaluation after the last dose of study medication).
Each subject will be required to complete a daily treatment diary to assess dosing compliance, adverse events, and concomitant medications. Each subject will receive one treatment diary at SD1, weeks 8, 12, and 24.
Subjects will be required to record daily diary entries that will capture dosing compliance, adverse events, and concomitant medications. Depending upon treatment allocation and subject tolerability, dose titration will be increased as follows:
Scheduled study visits include screening, baseline, and weeks 8, 12, and 24. Dosage adjustments will be based on subject tolerability and telephone assessments from study drug initiation through week 6. Trunk fat will be measured at SD1, weeks 12 and 24 (or early termination visit). Routine clinical laboratory assessments (hematology, blood chemistries, and urinalysis) will be performed pre-treatment (-30 to -1 SD1) and post-treatment on week 24 (or early termination visit). Special laboratory assessments include the central analysis of lipid panel, fasting insulin, fasting glucose, IGF-I, IGFBP-3, free T4 , total T4, CRP. Physical exams will be performed at screening, weeks 12 and 24. Safety evaluations will occur during scheduled study visits, through telephone assessments, and by the review of adverse events and concomitant events on the subject treatment diary.
Ages Eligible for Study: | 13 Years to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The day of entry or Study Day 1 is defined as the first day of study treatment. To be eligible for inclusion into this study, the subjects must fulfill all of the following criteria within 30 days prior to Study Day 1.
Exclusion Criteria:
To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
United States, California | |
Children's Hospital of Orange County | |
Orange, California, United States, 92868 | |
United States, Florida | |
Pediatric Endocrinology Children's Clinic | |
Tallahassee, Florida, United States, 32308 | |
Nemours Children's Clinic | |
Orlando, Florida, United States, 32806 | |
Nemours Children's Clinic | |
Jacksonville, Florida, United States, 32226 | |
United States, Georgia | |
Pediatric Endocrine Associates | |
Atlanta, Georgia, United States, 30342 | |
United States, New York | |
Women's and Children's Hospital of Buffalo | |
Buffalo, New York, United States, 14222 | |
Columbia University | |
New York, New York, United States, 10032 | |
United States, Pennsylvania | |
Children's Hospital of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Wisconsin | |
Children's Hospital of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 |
Study ID Numbers: | 25253 |
Study First Received: | May 2, 2005 |
Last Updated: | March 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00109733 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Childhood-onset growth hormone deficiency (COGHD) Saizen® |
Dwarfism Bone Diseases, Endocrine Hypothalamic Diseases Hypopituitary Dwarfism Pituitary Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Central Nervous System Diseases Dwarfism, Pituitary |
Brain Diseases Hormones Bone Diseases Growth Hormone Deficiency Musculoskeletal Diseases Genetic Diseases, Inborn Hypopituitarism Bone Diseases, Developmental Endocrinopathy |
Dwarfism Bone Diseases, Endocrine Hypothalamic Diseases Pituitary Diseases Physiological Effects of Drugs Nervous System Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Central Nervous System Diseases |
Dwarfism, Pituitary Brain Diseases Hormones Bone Diseases Pharmacologic Actions Musculoskeletal Diseases Genetic Diseases, Inborn Hypopituitarism Bone Diseases, Developmental |