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Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects

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NCT01112865

Last updated on March 22, 2018
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FOR MORE INFORMATION
Study Location
Fakultni Nemocnice Brno
Brno - mesto, , 61300 Czech Republic
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Growth Hormone Deficiency
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
4+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Age greater than or equal to 8 years.

- Subjects who are starting treatment with growth hormone (Genotropin) for the first
time.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects with Prader-Willi syndrome or chronic renal insufficiency.

- 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.

NCT01112865
Pfizer
Completed
Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects

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[email protected]

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Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects
A Multicenter, Open-label, Randomized Two Arm Cross Over Study Assessing Dyad (Subject and Caregiver) and Adult Subject Perception of Convenience and Preference of the Newly Developed Genotropin Mark VII Pen.
Convenience and preference for the new Mark VII pen compared to the current Genotropin pen will be assessed using a questionaire. it is expected that the new pen will be preferred or at least no different to the current pen.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Growth Hormone Deficiency
  • Device: 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.
  • Device: 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.
  • Device: 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/Current pen
    Subject will use Mark VII pen for 2 months followed by Current pen for 2 months
    Interventions:
    • Device: Genotropin Pen
    • Device: MARK VII pen
  • Current pen/Mark VII
    Subject will use current Genotropin pen for 2 months followed by Mark VII pen for 2 months
    Interventions:
    • Device: Genotropin Pen
    • Device: MARK VII pen
Pleil AM, Darendeliler F, Dörr 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-naïve children and adults. Med Devices (Auckl). 2014 Apr 11;7:61-71. doi: 10.2147/MDER.S59821. eCollection 2014.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
October 2011
October 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age greater than or equal to 8 years.
  • Subjects who are starting treatment with growth hormone (Genotropin) for the first time.

Exclusion Criteria:

  • Subjects with Prader-Willi syndrome or chronic renal insufficiency.
  • 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.
Sexes Eligible for Study: All
4 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Germany,   Netherlands,   Slovakia,   Sweden,   Turkey,   United Kingdom
 
 
NCT01112865
A6281297
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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