Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method - Full Text View

Sponsor:	Teva Pharmaceutical Industries
Information provided by:	Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:	NCT00990340

Purpose

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®)

Condition	Intervention	Phase
Growth Hormone Deficiency	Device: T-jet® containing TevTropin® Procedure: TevTropin® needle-syringe injection method	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: combined pituitary hormone deficiency pseudoachondroplasia

MedlinePlus related topics: Anxiety

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:

Subject-reported Injection Anxiety Immediately Before Administration [ Time Frame: 28 days; Period 1: 14 days, Period 2: 14 days ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Subject-reported Injection Pain Immediately Following Administration. [ Time Frame: 28 days; Period 1: 14 days, Period 2: 14 days ] [ Designated as safety issue: No ]
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.
Subject or Caregiver Reported Perception of Ease of Preparation as Recorded Weekly on a 5-point Scale. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
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.
Subject or Caregiver Reported Perception of Ease of Administration as Recorded Weekly on a 5-point Scale. [ Time Frame: 28 Days; end of Period 1(14 days) and end of Period 2 (14 days) ] [ Designated as safety issue: No ]
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.
Subject-reported Overall Satisfaction Following the End of Each Period of the Study. [ Time Frame: 28 Days; end of Period 1(14 days) and end of Period 2 (14 days) ] [ Designated as safety issue: No ]
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.

Enrollment:	52
Study Start Date:	September 2009
Study Completion Date:	August 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Tev-Tropin® needle-free needle-free injection method (T-jet®)for 14 days before cross-over to other arm	Device: T-jet® containing TevTropin® Needle-free delivery method for 14 days before cross-over to other arm Other Name: T-jet®
Active Comparator: Tev-Tropin® by Needle-syringe needle-syringe injection 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 Other Name: TevTropin® needle-syringe injection method

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).

Eligibility

Ages Eligible for Study:	7 Years to 17 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00990340

Sponsors and Collaborators

Teva Pharmaceutical Industries

Investigators

Study Director:

Thomas Smith, MD

Teva Pharmaceutical Industries

More Information

No publications provided

Responsible Party:	Iris Culbert; Clinical Trials Manager, Teva Neuroscience
ClinicalTrials.gov Identifier:	NCT00990340 History of Changes
Other Study ID Numbers:	PM201
Study First Received:	October 5, 2009
Results First Received:	March 14, 2011
Last Updated:	June 23, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine

Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012