Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects
NCT ID: NCT01112865
Last Updated: 2012-05-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
2010-08-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Mark VII/Current pen
Subject will use Mark VII pen for 2 months followed by Current pen for 2 months
Genotropin Pen
Pen provided in 5, 5.3 and 12 mg doses, Dose based on body weight, subcutaneous injection daily for 2 months while in study.
MARK VII pen
Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.
Current pen/Mark VII
Subject will use current Genotropin pen for 2 months followed by Mark VII pen for 2 months
Genotropin Pen
Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.
MARK VII pen
Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.
Interventions
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Genotropin Pen
Pen provided in 5, 5.3 and 12 mg doses, Dose based on body weight, subcutaneous injection daily for 2 months while in study.
MARK VII pen
Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.
Genotropin Pen
Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.
MARK VII pen
Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.
Eligibility Criteria
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Inclusion Criteria
* Subjects who are starting treatment with growth hormone (Genotropin) for the first time.
Exclusion Criteria
* Subjects and caregivers who, in the opinion of the investigator are not able to adequately participate in the study.
* Subjects with chronic systemic disorders, such as diabetes and heart disease.
4 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Fakultni Nemocnice Brno
Brno - Mesto, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Vestische Kinder- und Jugendklinik Datteln
Datteln, , Germany
Universitaetsklinik fuer Kinder und Jugendliche
Erlangen, , Germany
Privatpraxis
Gauting, , Germany
Praxis fuer paediatrische Endokrinologie
Niederrad, , Germany
Privatpraxis
Oldenburg, , Germany
Sophia Kinderziekenhuis
Rotterdam, , Netherlands
Juliana Kinderziekenhuis / Endocrinologie
The Hague, , Netherlands
Narodny endokrinologicky a diabetologicky ustav
Ľubochňa, Slovakia, Slovakia
Detska fakultna nemonica s poliklinikou, II. Detska klinika
Bratislava, , Slovakia
Sahlgrenska Universitetssjukhuset, Centrum for Endokrinologi och Metabolism (CEM)
Gothenburg, , Sweden
Drottning Silvias barn- och ungdomssjukhus, SU/Ostra
Gothenburg, , Sweden
Barn och Ungdomsmedicinkliniken
Linköping, , Sweden
Barnmedicinkliniken N
Umeå, , Sweden
Ankara University Medical Faculty Department of Internal Diseases
Sihhiye, Ankara, Turkey (Türkiye)
Istanbul University Istanbul Medical Faculty Department of Pediatric Health and Diseases
Çapa, Istanbul, Turkey (Türkiye)
Salford Royal NHS Foundation Trust, Hope Hospital
Salford, Manchester, United Kingdom
Royal Hospital for Sick Children
Glasgow, , United Kingdom
St Thomas Hospital
London, , United Kingdom
Norfolk and Norwich University Hospital
Norwich, , United Kingdom
Countries
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References
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Pleil AM, Darendeliler F, Dorr HG, Hutchinson K, Wollmann HA. Results from an international multicenter trial evaluating the ease-of-use of and preference for a newly developed disposable injection pen for the treatment of growth hormone deficiency in treatment-naive children and adults. Med Devices (Auckl). 2014 Apr 11;7:61-71. doi: 10.2147/MDER.S59821. eCollection 2014.
Related Links
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Other Identifiers
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A6281297
Identifier Type: -
Identifier Source: org_study_id
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