Primary outcomeMean· 28 days; Period 1: 14 days, Period 2: 14 days
Subject-reported Injection Anxiety Immediately Before Administration
| Group | Value (Scores on a scale) | Spread |
|---|---|---|
| TevTropin® Needle-free | 2.15 | 1.019 |
| TevTropin® by Needle-syringe | 1.98 | 1.024 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataComparison of a Needle-free Injection Method With a Needle-syringe Injection Method
Short name T-jet®
NCTNCT00990340 (opens ClinicalTrials.gov in a new tab)Other idPM201
This trial does not test a peptide that PepBank tracks.
- Measures HGH (somatotropin), does not give it. It appears in the eligibility rules.
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 52 participants (actual)
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc. · Industry
- Design
- Randomized · Open label (no masking)
- Countries
- Not stated
- Start
- Sept 2009
- Primary completion
- Jun 2010
- Completion
- Aug 2010
- First posted
- 6 Oct 2009 (estimated)
- Last update posted
- 25 Jul 2011 (estimated)
- Conditions
- Growth Hormone Deficiency
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200920102011
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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®)
Interventions
- T-jet® containing TevTropin®Device
- TevTropin® needle-syringe injection methodProcedure
Arms2
Active comparator
Tev-Tropin® needle-free
needle-free injection method (T-jet®)for 14 days before cross-over to other arm
Active comparator
Tev-Tropin® by Needle-syringe
needle-syringe injection method for 14 days before cross-over to other arm
Primary outcomes1
Outcomes the sponsor listed as primary.
Subject-reported Injection Anxiety Immediately Before Administration
Time frame · 28 days; Period 1: 14 days, Period 2: 14 days
Registry description
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 outcomes(4)
Subject-reported Injection Pain Immediately Following Administration.
Time frame · 28 days; Period 1: 14 days, Period 2: 14 days
Registry description
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
Registry description
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)
Registry description
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)
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(4)
Secondary outcomeLeast squares mean· 28 days; Period 1: 14 days, Period 2: 14 days
Subject-reported Injection Pain Immediately Following Administration.
| Group | Value (Scores on a scale) | Spread |
|---|---|---|
| TevTropin® Needle-free | 0.96 | 0.994 |
| TevTropin® by Needle-syringe | 0.89 | 1.015 |
Secondary outcomeLeast squares mean· 2 weeks
Subject or Caregiver Reported Perception of Ease of Preparation as Recorded Weekly on a 5-point Scale.
| Group | Value (Scores on a scale) | Spread |
|---|---|---|
| TevTropin® Needle-free | 2.55 | 1.222 |
| TevTropin® by Needle-syringe | 1.78 | 0.967 |
Secondary outcomeLeast squares mean· 28 Days; end of Period 1(14 days) and end of Period 2 (14 days)
Subject or Caregiver Reported Perception of Ease of Administration as Recorded Weekly on a 5-point Scale.
| Group | Value (Scores on a scale) | Spread |
|---|---|---|
| TevTropin® Needle-free Followed by TevTropin® Syringe | 2.40 | 1.246 |
| TevTropin® by Needle-syringe Followed byTevTropin® Needle-free | 1.76 | 1.052 |
Secondary outcomeLeast squares mean· 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.
| Group | Value (Scores on a scale) | Spread |
|---|---|---|
| TevTropin® Needle-free | 3.31 | 1.339 |
| TevTropin® by Needle-syringe | 3.96 | 1.147 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| TevTropin® Needle-free Followed by TevTropin® Syringeneedle-free injection method (T-jet®)for 14 days before cross-over to other arm | – | 0 / 42 | 0 / 42 |
| TevTropin® by Needle-syringe Followed byTevTropin® Needle-freeneedle-syringe injection method for 14 days before cross-over to other arm | – | 0 / 42 | 0 / 42 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 7 Years up to 17 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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