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

NCT00990340 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2011-07-25

Study results available
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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®)

Conditions

  • Growth Hormone Deficiency

Interventions

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

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Smith, MD · Teva Pharmaceutical Industries, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-06-30
Completion
2010-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00990340 on ClinicalTrials.gov