NCT00990340

Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method

Study to Compare Injection Anxiety Immediately Before the Administration of Each Dose of Tev-Tropin® Between a Needle-syringe Injection Method and a Needle-free Injection Method in Pediatric Subjects With Human Growth Hormone Deficiency

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: Male
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to obtain psychological response and user preference information on the use of the T jet® device versus the traditional subcutaneous injection administration of Tev Tropin®. This study will compare subject-reported injection anxiety immediately before the administration of each dose of Tev-Tropin® between a needle-syringe injection method and a needle-free injection method (T-jet®)

Detailed description

The primary efficacy endpoint was the difference in mean subject-reported injection anxiety between the two injection methods as recorded on a 5-point FIS immediately before administration. A higher score denoted greater anxiety. The injection anxiety score was to be reported by the subject from a row of five faces with values ranging from 5 (the face with the most negative affect) to 1 (the face with the most positive affect).

Conditions

• Growth Hormone Deficiency

Interventions

Type	Name	Description
DEVICE	T-jet® containing TevTropin®	Needle-free delivery method for 14 days before cross-over to other arm
PROCEDURE	TevTropin® needle-syringe injection method	comparison of delivery methods for 14 days before cross-over to other arm

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-06-01
• Completion: 2010-08-01
• First posted: 2009-10-06
• Last updated: 2011-07-25
• Results posted: 2011-07-25