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

NCT ID: NCT00990340

Last Updated: 2011-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tev-Tropin® needle-free

needle-free injection method (T-jet®)for 14 days before cross-over to other arm

Group Type: ACTIVE_COMPARATOR

T-jet® containing TevTropin®

Intervention Type: DEVICE

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

Tev-Tropin® by Needle-syringe

needle-syringe injection method for 14 days before cross-over to other arm

Group Type: ACTIVE_COMPARATOR

TevTropin® needle-syringe injection method

Intervention Type: PROCEDURE

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

Interventions

T-jet® containing TevTropin®

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

Intervention Type: DEVICE

TevTropin® needle-syringe injection method

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

Intervention Type: PROCEDURE

Other Intervention Names

T-jet®

Eligibility Criteria

Inclusion Criteria

• Subjects must require a routine Tev-Tropin® dose that does not exceed 2.5 mg in one injection (0.5 mL) using the dosing schedule individualized for each patient by their prescribing physician
• Male, age 7-17 years, with the capability to provide assent, as determined by the investigator and/or parent or legal guardian
• Clinically definite growth hormone deficiency as previously diagnosed by the investigator or other physician
• Subjects must be using Tev-Tropin® prior to enrollment for 28 days
• Informed consent signed by parent(s) or legal custodian of patient prior to study entry and patient assent as determined by the investigator and/or subject's parent or legal custodian

Exclusion Criteria

• More than one subcutaneous injection per Tev-Tropin® dose
• Female gender
• Use of any other needle-free injection device at any time
• Current use of another human growth hormone product other than Tev-Tropin®
• Concurrent treatment with other routine injectable medications
• History of benign intracranial hypertension
• Significant communication difficulties, or medical or psychiatric condition, that affects the subject's and/or caregiver's ability to perform the necessary functions to complete the study, or any condition which the investigator in their medical judgment thinks may interfere with participation in the study
• Use of an investigational drug within 30 days prior to randomization
• Contraindications related to routine use of Tev-Tropin® as per investigators' medical judgment (e.g., subjects with closed epiphyses, active proliferative or severe non-proliferative diabetic retinopathy, active malignancy, acute critical illness, or Prader-Willi syndrome who are severely obese or have severe respiratory impairment)
• Current participation in another pharmaceutical or device study
• Previous participation in this study

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Teva Neuroscience

Principal Investigators

Thomas Smith, MD

Role: STUDY_DIRECTOR

Teva Pharmaceutical Industries, Ltd.

Other Identifiers

PM201

Identifier Type: -

Identifier Source: org_study_id