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

NCT00990340 | Completed Phase 4 Results

• 1 other identifier: PM201
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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®)

Conditions

Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Subject-reported Injection Pain Immediately Following Administration.

  28 days; Period 1: 14 days, Period 2: 14 days

• Subject or Caregiver Reported Perception of Ease of Preparation as Recorded Weekly on a 5-point Scale.

  2 weeks

• Subject or Caregiver Reported Perception of Ease of Administration as Recorded Weekly on a 5-point Scale.

  28 Days; end of Period 1(14 days) and end of Period 2 (14 days)

• Subject-reported Overall Satisfaction Following the End of Each Period of the Study.

  28 Days; end of Period 1(14 days) and end of Period 2 (14 days)

Study Arms (2)

Tev-Tropin® needle-free

ACTIVE COMPARATOR

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

Device: T-jet® containing TevTropin®

Tev-Tropin® by Needle-syringe

ACTIVE COMPARATOR

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

Procedure: TevTropin® needle-syringe injection method

Interventions

T-jet® containing TevTropin® DEVICE

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

Also known as: T-jet®

Tev-Tropin® needle-free

TevTropin® needle-syringe injection method PROCEDURE

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

Tev-Tropin® by Needle-syringe

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

MeSH Terms

Conditions

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

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; Endocrine System Diseases

Results Point of Contact

• Title: Thomas Smith, MD, VP, Medical Affairs
• Organization: Teva Neuroscience

tom.smith@tevapharm.com

816-508-5000

Study Officials

• Thomas Smith, MD

  Teva Pharmaceutical Industries, Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 5, 2009
• First Posted: October 6, 2009
• Study Start: September 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: August 1, 2010
• Last Updated: July 25, 2011
• Results First Posted: July 25, 2011

Record last verified: 2011-06