NCT01112865

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Growth Hormone Deficiency

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2010-04-28
• Last updated: 2012-05-22
• Results posted: 2012-05-14

Locations

23 sites across 7 countries: Czechia, Germany, Netherlands, Slovakia, Sweden, Turkey (Türkiye), United Kingdom