Trial Outcomes & Findings for Easypod United States User Trial (NCT NCT00689260)
NCT ID: NCT00689260
Last Updated: 2015-05-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
42 participants
Primary outcome timeframe
90 Days
Results posted on
2015-05-15
Participant Flow
43 Subjects were randomized from 14 Clinics in the US from March 2008 through January 2009. One subject withdrew consent prior to first dose. Recruitment was ended early due to slow enrollment.
Screening and randomization took place at Visit 1 (Study Day 1) which consisted of informed consent, medical/disease history, physical exam and laboratory assessments.
Participant milestones
| Measure |
Log Aware
Dose Log Aware and Daily Diary Enabled
|
Log Unaware
Dose Log UnaAware and Daily Diary Disabled
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
19
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Easypod United States User Trial
Baseline characteristics by cohort
| Measure |
Log Aware
n=21 Participants
Dose Log Aware and Daily Diary Enabled
|
Log Unaware
n=21 Participants
Dose Log UnaAware and Daily Diary Disabled
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
21 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
12.4 years
STANDARD_DEVIATION 1.50 • n=99 Participants
|
13.0 years
STANDARD_DEVIATION 2.56 • n=107 Participants
|
12.7 years
STANDARD_DEVIATION 2.10 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
21 participants
n=107 Participants
|
42 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 90 DaysPopulation: The modified full analysis set includes all randomized subjects who received at least one injection using the easypod device and had valid device data. Seven subjects who had damaged devices or incorrect device setting were excluded from this analysis set.
Outcome measures
| Measure |
Log Aware
n=15 Participants
Dose Log Aware and Daily Diary Enabled
|
Log Unaware
n=20 Participants
Dose Log UnaAware and Daily Diary Disabled
|
Total
n=35 Participants
|
|---|---|---|---|
|
Percent rhGH Injections Missed During the Treatment Period (Based on the Easypod™ Injection Log)
|
20 Percent of injections missed
Interval 0.0 to 71.7
|
19.46 Percent of injections missed
Interval 1.1 to 90.9
|
20 Percent of injections missed
Interval 0.0 to 90.9
|
SECONDARY outcome
Timeframe: 90 DaysPopulation: The modified full analysis set includes all randomized subjects who received at least one injection using the Easypod device and had valid device data. In addition, this total of 35 subjects was divided into 2 groups, Humatrope and Genotropin, based on their previous rhGH use.
Outcome measures
| Measure |
Log Aware
n=16 Participants
Dose Log Aware and Daily Diary Enabled
|
Log Unaware
n=19 Participants
Dose Log UnaAware and Daily Diary Disabled
|
Total
n=35 Participants
|
|---|---|---|---|
|
Subjects Perception of Easypod Ease of Use Compared to Two Other rhGH Pen Injection Devices
Strongly Agree
|
5 Participants
|
5 Participants
|
10 Participants
|
|
Subjects Perception of Easypod Ease of Use Compared to Two Other rhGH Pen Injection Devices
Agree
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Subjects Perception of Easypod Ease of Use Compared to Two Other rhGH Pen Injection Devices
Neutral
|
0 Participants
|
4 Participants
|
4 Participants
|
|
Subjects Perception of Easypod Ease of Use Compared to Two Other rhGH Pen Injection Devices
Disagree
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Subjects Perception of Easypod Ease of Use Compared to Two Other rhGH Pen Injection Devices
Strongly Disagree
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Subjects Perception of Easypod Ease of Use Compared to Two Other rhGH Pen Injection Devices
Missing
|
5 Participants
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 90 DaysPopulation: The modified full analysis set includes all randomized subjects who received at least one injection using the easypod device and had valid device data. In addition, this total of 35 subjects was divided into 2 groups, Humatrope and Genotropin, based on their previous rhGH use.
Outcome measures
| Measure |
Log Aware
n=16 Participants
Dose Log Aware and Daily Diary Enabled
|
Log Unaware
n=19 Participants
Dose Log UnaAware and Daily Diary Disabled
|
Total
n=35 Participants
|
|---|---|---|---|
|
Subject Perceptions of Easypod: Storage Convenience Compared to Two Other rhGH Pen Injection Devices.
Very Convenient
|
3 Participants
|
7 Participants
|
10 Participants
|
|
Subject Perceptions of Easypod: Storage Convenience Compared to Two Other rhGH Pen Injection Devices.
Convenient
|
3 Participants
|
5 Participants
|
8 Participants
|
|
Subject Perceptions of Easypod: Storage Convenience Compared to Two Other rhGH Pen Injection Devices.
Neutral
|
5 Participants
|
3 Participants
|
8 Participants
|
|
Subject Perceptions of Easypod: Storage Convenience Compared to Two Other rhGH Pen Injection Devices.
Not Very Convenient
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Subject Perceptions of Easypod: Storage Convenience Compared to Two Other rhGH Pen Injection Devices.
Not at all Convenient
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Subject Perceptions of Easypod: Storage Convenience Compared to Two Other rhGH Pen Injection Devices.
Missing
|
5 Participants
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 90 DaysPopulation: The modified full analysis set includes all randomized subjects who received at least one injection using the easypod device and had valid device data. In addition, this total of 35 subjects was divided into 2 groups, Humatrope and Genotropin, based on their previous rhGH use.
Outcome measures
| Measure |
Log Aware
n=16 Participants
Dose Log Aware and Daily Diary Enabled
|
Log Unaware
n=19 Participants
Dose Log UnaAware and Daily Diary Disabled
|
Total
n=35 Participants
|
|---|---|---|---|
|
Subject Perceptions of Easypod: Preference to Use Easypod Over Two Other rhGH Pen Injection Devices.
Strongly Disagree
|
3 Participants
|
4 Participants
|
7 Participants
|
|
Subject Perceptions of Easypod: Preference to Use Easypod Over Two Other rhGH Pen Injection Devices.
Missing
|
5 Participants
|
3 Participants
|
8 Participants
|
|
Subject Perceptions of Easypod: Preference to Use Easypod Over Two Other rhGH Pen Injection Devices.
Strongly Agree
|
2 Participants
|
6 Participants
|
8 Participants
|
|
Subject Perceptions of Easypod: Preference to Use Easypod Over Two Other rhGH Pen Injection Devices.
Agree
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Subject Perceptions of Easypod: Preference to Use Easypod Over Two Other rhGH Pen Injection Devices.
Neutral
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Subject Perceptions of Easypod: Preference to Use Easypod Over Two Other rhGH Pen Injection Devices.
Disagree
|
2 Participants
|
3 Participants
|
5 Participants
|
Adverse Events
Log Aware
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Log Unaware
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Log Aware
n=21 participants at risk
Dose Log Aware and Daily Diary Enabled
|
Log Unaware
n=21 participants at risk
Dose Log UnaAware and Daily Diary Disabled
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brainstem Tumor
|
4.8%
1/21 • Number of events 1 • Day 1, Week 12 and Four Week Follow-up
|
0.00%
0/21 • Day 1, Week 12 and Four Week Follow-up
|
|
Nervous system disorders
Syncopal episodes
|
0.00%
0/21 • Day 1, Week 12 and Four Week Follow-up
|
4.8%
1/21 • Number of events 1 • Day 1, Week 12 and Four Week Follow-up
|
Other adverse events
| Measure |
Log Aware
n=21 participants at risk
Dose Log Aware and Daily Diary Enabled
|
Log Unaware
n=21 participants at risk
Dose Log UnaAware and Daily Diary Disabled
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/21 • Day 1, Week 12 and Four Week Follow-up
|
4.8%
1/21 • Day 1, Week 12 and Four Week Follow-up
|
|
General disorders
Injection site haematoma
|
4.8%
1/21 • Day 1, Week 12 and Four Week Follow-up
|
0.00%
0/21 • Day 1, Week 12 and Four Week Follow-up
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/21 • Day 1, Week 12 and Four Week Follow-up
|
4.8%
1/21 • Day 1, Week 12 and Four Week Follow-up
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/21 • Day 1, Week 12 and Four Week Follow-up
|
4.8%
1/21 • Day 1, Week 12 and Four Week Follow-up
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
1/21 • Day 1, Week 12 and Four Week Follow-up
|
0.00%
0/21 • Day 1, Week 12 and Four Week Follow-up
|
|
Injury, poisoning and procedural complications
Back Injury
|
0.00%
0/21 • Day 1, Week 12 and Four Week Follow-up
|
4.8%
1/21 • Day 1, Week 12 and Four Week Follow-up
|
|
Nervous system disorders
Headache
|
4.8%
1/21 • Day 1, Week 12 and Four Week Follow-up
|
0.00%
0/21 • Day 1, Week 12 and Four Week Follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/21 • Day 1, Week 12 and Four Week Follow-up
|
4.8%
1/21 • Day 1, Week 12 and Four Week Follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The institution or Principal Investigator can publish or present any results to a third party until (i) EMD Serono publishes the results (ii) Institution receives notification from EMD Serono that publication is no longer planned (iii) 18 months following the completion of the study whichever occurs first. Prior to publishing or presenting results, the Principal Investigator needs to provide EMD Serono with a copy of the presentation for review and approval.
- Publication restrictions are in place
Restriction type: OTHER