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

Growth Hormone Deficiency Clinical Trial

— T-jet®  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00990340
• Other study ID #: PM201
• Status: Completed
• Phase: Phase 4
• First received: October 5, 2009
• Last updated: June 23, 2011
• Start date: September 2009
• Est. completion date: August 2010

Study information

• Verified date: June 2011
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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®)

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 7 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Deficiency

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceutical Industries

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject-reported Injection Anxiety Immediately Before Administration	The difference in mean subject-reported injection anxiety between the two injection methods as recorded on a 5 point scale immediately before administration, which scale consisted of a row of five faces with values from 1(most positive)to 5(most negative or greater anxiety.) The score is an average of the Period 1 (Days 1-14) and Period 2 (Days 15-28) assessments; like groups were combined and then averaged. There were 3 visits: Visit 1 (Begin Period 1) Screening and Randomized assignment, Visit 2 (first day of Period 2) Cross over to other assignment, Visit 3 End of Study.	28 days; Period 1: 14 days, Period 2: 14 days	No
Secondary	Subject-reported Injection Pain Immediately Following Administration.	The difference in mean subject-reported injection anxiety between the two injection methods as recorded on a 5 point scale immediately before administration, which scale consisted of a row of five faces with values from 1(most positive)to 5(most negative or greater anxiety.) The score is an average of the Period 1 (Days 1-14) and Period 2 (Days 15-28) assessments; like groups were combined and then averaged. There were 3 visits: Visit 1 (Begin Period 1) Screening and Randomized assignment, Visit 2 (first day of Period 2) Cross over to other assignment, Visit 3 End of Study.	28 days; Period 1: 14 days, Period 2: 14 days	No
Secondary	Subject or Caregiver Reported Perception of Ease of Preparation as Recorded Weekly on a 5-point Scale.	The difference in mean subject-reported injection anxiety between the two injection methods as recorded on a 5 point scale immediately before administration, which scale consisted of a row of five faces with values from 1(most positive)to 5(most negative or greater anxiety.) The score is an average of the Period 1 (Days 1-14) and Period 2 (Days 15-28) assessments; like arms were combined and then averaged. There were 3 visits: Visit 1 (Begin Period 1) Screening and Randomized assignment, Visit 2 (first day of Period 2) Cross over to other assignment, Visit 3 End of Study.	2 weeks	No
Secondary	Subject or Caregiver Reported Perception of Ease of Administration as Recorded Weekly on a 5-point Scale.	The difference in subject-reported overall satisfaction between the two injection methods as recorded on a 5-point scale following the end of each period of the study. The overall satisfaction was to be rated by the subject on a 5-point scale as 1 (Really Unhappy) to 5 (Really Happy), a higher score denoting greater satisfaction. Overall satisfaction is obtained only once at the end of each period; Period 1 Tjet group was added to Period 2 Tjet group and Period 1 syringe group was added to Period 2 syringe group; no averaging was necessary.	28 Days; end of Period 1(14 days) and end of Period 2 (14 days)	No
Secondary	Subject-reported Overall Satisfaction Following the End of Each Period of the Study.	The difference in subject-reported overall satisfaction between the two injection methods as recorded on a 5-point scale following the end of each period of the study. The overall satisfaction was to be rated by the subject on a 5-point scale as 1 (Really Unhappy) to 5 (Really Happy), a higher score denoting greater satisfaction. Overall satisfaction is obtained only once at the end of each period; Period 1 Tjet group was added to Period 2 Tjet group and Period 1 syringe group was added to Period 2 syringe group; no averaging was necessary.	28 Days; end of Period 1(14 days) and end of Period 2 (14 days)	No