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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Growth Hormone Deficiency

Treatments: Device: Genotropin Pen; Device: MARK VII pen

Study type: Interventional

Funder types: Industry

Identifiers

NCT01112865

A6281297

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Mark VII/Current pen

Other group

Description:

Subject will use Mark VII pen for 2 months followed by Current pen for 2 months

Treatment:

Device: MARK VII pen

Device: Genotropin Pen

Device: MARK VII pen

Device: Genotropin Pen

Current pen/Mark VII

Other group

Description:

Subject will use current Genotropin pen for 2 months followed by Mark VII pen for 2 months

Treatment:

Device: MARK VII pen

Device: Genotropin Pen

Device: MARK VII pen

Device: Genotropin Pen