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

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NCT01112865

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Study Location
Fakultni Nemocnice Brno
Brno - mesto, , 61300, Czech Republic
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Contact
1-800-718-1021
[email protected]
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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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Growth Hormone Deficiency
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 21, 2011)		120
Original Estimated Enrollment  ICMJE
 (submitted: April 27, 2010)		150
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 4 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   Germany,   Netherlands,   Slovakia,   Sweden,   Turkey,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01112865
Other Study ID Numbers  ICMJE A6281297
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP