Trial Outcomes & Findings for Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method (NCT NCT00990340)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

52 participants

Primary outcome timeframe

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

Results posted on

2011-07-25

Participant Flow

First subject enrolled on 23 September 2009; last subject completed the study on 07 April 2010.

Participant milestones

Participant milestones
Measure	TevTropin® Needle-free Followed by TevTropin® Syringe needle-free injection method (T-jet®)for 14 days before cross-over to other arm	TevTropin® by Needle-syringe Followed byTevTropin® Needle-free needle-syringe injection method for 14 days before cross-over to other arm
First 14-day Treatment STARTED	27	25
First 14-day Treatment COMPLETED	21	21
First 14-day Treatment NOT COMPLETED	6	4
Second 14-day Treatment STARTED	21	21
Second 14-day Treatment COMPLETED	21	21
Second 14-day Treatment NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	TevTropin® Needle-free Followed by TevTropin® Syringe needle-free injection method (T-jet®)for 14 days before cross-over to other arm	TevTropin® by Needle-syringe Followed byTevTropin® Needle-free needle-syringe injection method for 14 days before cross-over to other arm
First 14-day Treatment Not Compliant	2	1
First 14-day Treatment Lost to Follow-up	2	1
First 14-day Treatment Protocol Violation	2	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TevTropin® Needle-free Followed by TevTropin® Syringe n=27 Participants needle-free injection method (T-jet®)for 14 days before cross-over to other arm	TevTropin® by Needle-syringe Followed byTevTropin® Needle-free n=25 Participants needle-syringe injection method for 14 days before cross-over to other arm	Total n=52 Participants Total of all reporting groups
Age, Categorical <=18 years	27 Participants n=5 Participants	25 Participants n=7 Participants	52 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	12.3 years STANDARD_DEVIATION 2.31 • n=5 Participants	12.5 years STANDARD_DEVIATION 2.14 • n=7 Participants	12.4 years STANDARD_DEVIATION 2.23 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	25 Participants n=7 Participants	52 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	25 participants n=7 Participants	52 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	TevTropin® Needle-free n=42 Participants Needle-free injection method (T-jet®)for 14 days before cross-over to other arm for 14 days	TevTropin® by Needle-syringe n=42 Participants Needle-syringe injection method for 14 days before cross-over to other arm for 14 days
Subject-reported Injection Anxiety Immediately Before Administration	2.15 Scores on a scale Standard Deviation 1.019 • Interval 44.6 to 60.7	1.98 Scores on a scale Standard Deviation 1.024 • Interval 38.7 to 54.9

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	TevTropin® Needle-free n=42 Participants Needle-free injection method (T-jet®)for 14 days before cross-over to other arm for 14 days	TevTropin® by Needle-syringe n=42 Participants Needle-syringe injection method for 14 days before cross-over to other arm for 14 days
Subject-reported Injection Pain Immediately Following Administration.	0.96 Scores on a scale Standard Deviation 0.994	0.89 Scores on a scale Standard Deviation 1.015

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	TevTropin® Needle-free n=42 Participants Needle-free injection method (T-jet®)for 14 days before cross-over to other arm for 14 days	TevTropin® by Needle-syringe n=42 Participants Needle-syringe injection method for 14 days before cross-over to other arm for 14 days
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	1.78 Scores on a scale Standard Deviation 0.967

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	TevTropin® Needle-free n=42 Participants Needle-free injection method (T-jet®)for 14 days before cross-over to other arm for 14 days	TevTropin® by Needle-syringe n=42 Participants Needle-syringe injection method for 14 days before cross-over to other arm for 14 days
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	1.76 Scores on a scale Standard Deviation 1.052

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	TevTropin® Needle-free n=42 Participants Needle-free injection method (T-jet®)for 14 days before cross-over to other arm for 14 days	TevTropin® by Needle-syringe n=42 Participants Needle-syringe injection method for 14 days before cross-over to other arm for 14 days
Subject-reported Overall Satisfaction Following the End of Each Period of the Study.	3.31 Scores on a scale Standard Deviation 1.339	3.96 Scores on a scale Standard Deviation 1.147

Adverse Events

TevTropin® Needle-free Followed by TevTropin® Syringe

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TevTropin® by Needle-syringe Followed byTevTropin® Needle-free

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thomas Smith, MD, VP, Medical Affairs

Teva Neuroscience

Phone: 816-508-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER