Growth Hormone Deficiency
Conditions
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®)
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).
Interventions
DEVICET-jet® containing TevTropin®
Needle-free delivery method for 14 days before cross-over to other arm
PROCEDURETevTropin® needle-syringe injection method
comparison of delivery methods for 14 days before cross-over to other arm
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
7 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject-reported Injection Anxiety Immediately Before Administration | 28 days; Period 1: 14 days, Period 2: 14 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Subject-reported Injection Pain Immediately Following Administration. | 28 days; Period 1: 14 days, Period 2: 14 days | 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. | 2 weeks | 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. | 28 Days; end of Period 1(14 days) and end of Period 2 (14 days) | 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. | 28 Days; end of Period 1(14 days) and end of Period 2 (14 days) | 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. |
Participant flow
Recruitment details
First subject enrolled on 23 September 2009; last subject completed the study on 07 April 2010.
Participants by arm
| Arm | Count |
|---|---|
| TevTropin® Needle-free Followed by TevTropin® Syringe needle-free injection method (T-jet®)for 14 days before cross-over to other arm | 27 |
| TevTropin® by Needle-syringe Followed byTevTropin® Needle-free needle-syringe injection method for 14 days before cross-over to other arm | 25 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First 14-day Treatment | Lost to Follow-up | 2 | 1 |
| First 14-day Treatment | Not Compliant | 2 | 1 |
| First 14-day Treatment | Protocol Violation | 2 | 2 |
Baseline characteristics
| Characteristic | TevTropin® by Needle-syringe Followed byTevTropin® Needle-free | TevTropin® Needle-free Followed by TevTropin® Syringe | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 25 Participants | 27 Participants | 52 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 12.5 years STANDARD_DEVIATION 2.14 | 12.3 years STANDARD_DEVIATION 2.31 | 12.4 years STANDARD_DEVIATION 2.23 |
| Region of Enrollment United States | 25 participants | 27 participants | 52 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 25 Participants | 27 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 42 | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 |
Outcome results
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.
Time frame: 28 days; Period 1: 14 days, Period 2: 14 days
Population: Of the 52 subjects enrolled, 10 were unevaluable as follows: 4 discontinuations (2 adverse events, 1 lost to follow up, 1 inconsistent participation) 3 non-compliant dosing or diary use, 3 protocol violations ( 2 received devices out of randomized sequence, 1 interruption of injection due to device malfunction.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TevTropin® Needle-free | Subject-reported Injection Anxiety Immediately Before Administration | 2.15 Scores on a scale | Standard Deviation 1.019 |
| TevTropin® by Needle-syringe | Subject-reported Injection Anxiety Immediately Before Administration | 1.98 Scores on a scale | Standard Deviation 1.024 |
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.
Time frame: 28 Days; end of Period 1(14 days) and end of Period 2 (14 days)
Population: Of the 52 subjects enrolled, 10 were unevaluable as follows: 4 discontinuations (2 adverse events, 1 lost to follow up, 1 inconsistent participation) 3 non-compliant dosing or diary use, 3 protocol violations ( 2 received devices out of randomized sequence, 1 interruption of injection due to device malfunction.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TevTropin® Needle-free | Subject or Caregiver Reported Perception of Ease of Administration as Recorded Weekly on a 5-point Scale. | 2.40 Scores on a scale | Standard Deviation 1.246 |
| TevTropin® by Needle-syringe | Subject or Caregiver Reported Perception of Ease of Administration as Recorded Weekly on a 5-point Scale. | 1.76 Scores on a scale | Standard Deviation 1.052 |
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.
Time frame: 2 weeks
Population: Of the 52 subjects enrolled, 10 were unevaluable as follows: 4 discontinuations (2 adverse events, 1 lost to follow up, 1 inconsistent participation) 3 non-compliant dosing or diary use, 3 protocol violations ( 2 received devices out of randomized sequence, 1 interruption of injection due to device malfunction.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TevTropin® Needle-free | Subject or Caregiver Reported Perception of Ease of Preparation as Recorded Weekly on a 5-point Scale. | 2.55 Scores on a scale | Standard Deviation 1.222 |
| TevTropin® by Needle-syringe | Subject or Caregiver Reported Perception of Ease of Preparation as Recorded Weekly on a 5-point Scale. | 1.78 Scores on a scale | Standard Deviation 0.967 |
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.
Time frame: 28 days; Period 1: 14 days, Period 2: 14 days
Population: Of the 52 subjects enrolled, 10 were unevaluable as follows: 4 discontinuations (2 adverse events, 1 lost to follow up, 1 inconsistent participation) 3 non-compliant dosing or diary use, 3 protocol violations ( 2 received devices out of randomized sequence, 1 interruption of injection due to device malfunction.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TevTropin® Needle-free | Subject-reported Injection Pain Immediately Following Administration. | 0.96 Scores on a scale | Standard Deviation 0.994 |
| TevTropin® by Needle-syringe | Subject-reported Injection Pain Immediately Following Administration. | 0.89 Scores on a scale | Standard Deviation 1.015 |
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.
Time frame: 28 Days; end of Period 1(14 days) and end of Period 2 (14 days)
Population: Of the 52 subjects enrolled, 10 were unevaluable as follows: 4 discontinuations (2 adverse events, 1 lost to follow up, 1 inconsistent participation) 3 non-compliant dosing or diary use, 3 protocol violations ( 2 received devices out of randomized sequence, 1 interruption of injection due to device malfunction.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TevTropin® Needle-free | Subject-reported Overall Satisfaction Following the End of Each Period of the Study. | 3.31 Scores on a scale | Standard Deviation 1.339 |
| TevTropin® by Needle-syringe | Subject-reported Overall Satisfaction Following the End of Each Period of the Study. | 3.96 Scores on a scale | Standard Deviation 1.147 |