Comparison of a Needle-free Injection Method (T-jet™) With a Needle-syringe Injection Method for the Delivery of Tev-Tropin® in Pediatric Subjects With Human Growth Hormone Deficiency - 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™ Procedure: needle-syringe injection method	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment
Official Title:	Phase IV Study to 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™) With a Maximum Single Dose of ≤ 2.5 mg/0.5 mL Using the Dosage Schedule Individualized for Each Patient by Their Prescribing Physician.

Resource links provided by NLM:

Genetics Home Reference related topics: 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:

The difference in mean subject-reported injection anxiety between the two injection methods as recorded on a 5 point scale immediately before administration [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

1.The difference in mean subject-reported injection pain between the two injection methods as recorded on a 6-point scale immediately following administration. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
2.The difference in mean subject- or caregiver-reported perception of ease of preparation between the two injection methods as recorded weekly on a 5-point scale. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
3.The difference in mean subject- or caregiver-reported perception of ease of administration between the two injection methods as recorded weekly on a 5-point scale. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
4. 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. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
5.The categorical subjects' preference for future use rating between the two injection methods following the end of the study [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	53
Study Start Date:	September 2009
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Tev-Tropin® needle-free: Active Comparator needle-free injection method (T-jet™)for 14 days before cross-over to other arm	Device: T-jet™ Needle-free delivery method for 14 days before cross-over to other arm
Tev-Tropin® by Needle-syringe: Active Comparator needle-syringe injection method for 14 days before cross-over to other arm	Procedure: needle-syringe injection method comparison of delivery methods for 14 days before cross-over to other arm

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 hGH 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

Contacts

Contact: Iris Culbert, MSHS	8165085273	iris.culbert@tevaneuro.com
Contact: Jill Conner, PhD	8165085195	jill.conner@tevaneuro.com

Locations

United States, Alabama
University of Alabama at Birmingham	Recruiting
Birmingham, Alabama, United States, 35206
United States, California
Children's Specialist Medical Group	Recruiting
Sacramento, California, United States, 95819
United States, Florida
Florida Hospital	Recruiting
Orlando, Florida, United States, 32806
Orlando Regional	Recruiting
Orlando, Florida, United States, 32806
Pediatric Endocrinology Consultants	Recruiting
Margate, Florida, United States, 33063
United States, Minnesota
Children's Hospital of Minneapolis	Recruiting
Minneapolis, Minnesota, United States, 55404
United States, New York
Maimonides/SUNY Downstate Infant and Children's Hospital	Recruiting
Brooklyn, New York, United States, 11219
Phelp's Memorial Hospital/New York Medical College	Recruiting
Sleepy Hollow, New York, United States, 10591
Albert Einstein College of Medicine	Recruiting
New Rochelle, New York, United States, 10804
United States, Ohio
Cleveland Clinic	Recruiting
Cleveland, Ohio, United States, 44195
United States, Washington
Swedish Hospital	Recruiting
Seattle, Washington, United States, 98105

Sponsors and Collaborators

Teva Pharmaceutical Industries

Investigators

Study Director:

Thomas Smith, MD

Teva Pharmaceutical Industries

More Information

No publications provided

Responsible Party:	Teva Neuroscience ( Iris Culbert; Clinical Trials Manager )
Study ID Numbers:	PM201
Study First Received:	October 5, 2009
Last Updated:	October 12, 2009
ClinicalTrials.gov Identifier:	NCT00990340 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Dwarfism
Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Nervous System Diseases
Endocrine System Diseases
Central Nervous System Diseases

Dwarfism, Pituitary
Brain Diseases
Bone Diseases
Musculoskeletal Diseases
Hypopituitarism
Bone Diseases, Developmental

ClinicalTrials.gov processed this record on February 09, 2010