CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 52 enrolled
Drug / intervention
T-jet® containing TevTropin® +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00990340
NCT00990340Phase 4Completed
CompareCT.gov

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

Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Oct 6, 2009·Updated Jul 25, 2011

In Brief

A Phase 4 clinical trial evaluating T-jet® containing TevTropin® and TevTropin® needle-syringe injection method for Growth Hormone Deficiency. Completed, enrolled 52 participants.

Detailed 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®)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGrowth Hormone Deficiency
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 6, 2009
Enrollment StartSep 1, 2009
Primary CompletionJun 1, 2010
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 16.7 years ago

Interventions

T-jet® containing TevTropin®device

Needle-free delivery method for 14 days before cross-over to other arm

TevTropin® needle-syringe injection methodprocedure

comparison of delivery methods for 14 days before cross-over to other arm