Growth Hormone DeficiencyPhase 4T-jet®NCT00990340
Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method
A Phase 4 study testing T-jet® containing TevTropin® and TevTropin® needle-syringe injection method in people with Growth Hormone Deficiency, run by Teva Branded Pharmaceutical Products R&D, Inc..
Trial 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®. Read more about this study
- Who is it for?
- Ages 7 to 17 years, men only
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- T-jet® containing TevTropin® and TevTropin® needle-syringe injection method
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Aug 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
Official title: Study to Compare Injection Anxiety Immediately Before the Administration of Each Dose of Tev-Tropin® Between a Needle-syringe Injection Method and a Needle-free Injection Method in Pediatric Subjects With Human Growth Hormone Deficiency
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®)
Read the 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).
- Conditions
- Growth Hormone Deficiency
- Being tested
- T-jet® containing TevTropin®, TevTropin® needle-syringe injection method
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-jet® containing TevTropin®Device
Also called T-jet®
Needle-free delivery method for 14 days before cross-over to other arm
TevTropin® needle-syringe injection methodProcedure or surgery
comparison of delivery methods for 14 days before cross-over to other arm
| Study group | Role | What they receive |
|---|---|---|
| Tev-Tropin® needle-free | Active comparator | needle-free injection method (T-jet®)for 14 days before cross-over to other arm Receives: 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 Receives: Procedure: TevTropin® needle-syringe injection method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days; Period 1: 14 days, Period 2: 14 days
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 28 Days; end of Period 1(14 days) and end of Period 2 (14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas Smith, MD, Study director, Teva Pharmaceutical Industries, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990340
- Sponsor's protocol ID
- PM201
- Acronym
- T-jet®
- Status last verified
- Jun 2011
- First submitted
- 5 Oct 2009
- Last updated
- 25 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Compare Injection Anxiety Immediately Before the Administration of Each Dose of Tev-Tropin® Between a Needle-syringe Injection Method and a Needle-free Injection Method in Pediatric Subjects With Human Growth Hormone Deficiency
- ClinicalTrials.gov ID
- NCT00990340
- Acronym / sponsor ID
- T-jet® / PM201
- Conditions
- Growth Hormone Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 6 Oct 2009 (estimated)
- Results
- Posted 25 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tev-Tropin® needle-free | Active comparator | Device: T-jet® containing TevTropin®needle-free injection method (T-jet®)for 14 days before cross-over to other arm |
| Tev-Tropin® by Needle-syringe | Active comparator | Procedure: TevTropin® needle-syringe injection methodneedle-syringe injection method for 14 days before cross-over to other arm |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-jet® containing TevTropin®Also: T-jet®Needle-free delivery method for 14 days before cross-over to other arm | Device | Tev-Tropin® needle-free |
| TevTropin® needle-syringe injection methodcomparison of delivery methods for 14 days before cross-over to other arm | Procedure or surgery | Tev-Tropin® by Needle-syringe |
Primary outcome
Subject-reported Injection Anxiety Immediately Before Administration
Time frame: 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.
4 secondary outcomes
Subject-reported Injection Pain Immediately Following Administration.
Time frame: 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.
Time frame: 2 weeks
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Smith, MD study director
Teva Pharmaceutical Industries, Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing T-jet® containing TevTropin® and TevTropin® needle-syringe injection method in people with Growth Hormone Deficiency, run by Teva Branded Pharmaceutical Products R&D, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject-reported Injection Anxiety Immediately Before Administration (time frame: 28 days; Period 1: 14 days, Period 2: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2011.