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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®)
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tev-Tropin® needle-free | Active Comparator | needle-free injection method (T-jet®)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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T-jet® containing TevTropin® | Device | Needle-free delivery method for 14 days before cross-over to other arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Smith, MD | Teva Pharmaceutical Industries, Ltd. | Study Director |
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First subject enrolled on 23 September 2009; last subject completed the study on 07 April 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | TevTropin® Needle-free Followed by TevTropin® Syringe | needle-free injection method (T-jet®)for 14 days before cross-over to other arm |
| FG001 | TevTropin® by Needle-syringe Followed byTevTropin® Needle-free | needle-syringe injection method for 14 days before cross-over to other arm |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First 14-day Treatment |
|
| |||||||||||||||||||||
| Second 14-day Treatment |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TevTropin® Needle-free Followed by TevTropin® Syringe | needle-free injection method (T-jet®)for 14 days before cross-over to other arm |
| BG001 | TevTropin® by Needle-syringe Followed byTevTropin® Needle-free |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | Scores on a scale | 28 days; Period 1: 14 days, Period 2: 14 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TevTropin® Needle-free Followed by TevTropin® Syringe | needle-free injection method (T-jet®)for 14 days before cross-over to other arm |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Smith, MD, VP, Medical Affairs | Teva Neuroscience | 816-508-5000 | tom.smith@tevapharm.com |
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| TevTropin® needle-syringe injection method | Procedure | comparison of delivery methods for 14 days before cross-over to other arm |
|
| 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. | 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. | 2 weeks |
| 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. | 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. | 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. | 28 Days; end of Period 1(14 days) and end of Period 2 (14 days) |
| Protocol Violation |
|
| NOT COMPLETED |
|
needle-syringe injection method for 14 days before cross-over to other arm
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| TevTropin® Needle-free |
Needle-free injection method (T-jet®)for 14 days before cross-over to other arm for 14 days |
| OG001 | TevTropin® by Needle-syringe | Needle-syringe injection method for 14 days before cross-over to other arm for 14 days |
|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Deviation | Scores on a scale | 28 days; Period 1: 14 days, Period 2: 14 days |
|
|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Deviation | Scores on a scale | 2 weeks |
|
|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Deviation | Scores on a scale | 28 Days; end of Period 1(14 days) and end of Period 2 (14 days) |
|
|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Deviation | Scores on a scale | 28 Days; end of Period 1(14 days) and end of Period 2 (14 days) |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | TevTropin® by Needle-syringe Followed byTevTropin® Needle-free | needle-syringe injection method for 14 days before cross-over to other arm | 0 | 42 | 0 | 42 |
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
| D001849 |
| Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |