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This study will help to determine whether an injection log on a recombinant human growth hormone (rhGH) delivery device improves subjects' adherence with injection schedules. Adherence will be compared between a group of subjects who are aware of the injection log on the easypodâ„¢ rhGH delivery device and a group of subjects who are not aware of the easypodâ„¢ injection log. It is the study hypothesis that subject non-adherence rate is different for those who are aware of the injection log capability versus those who are unaware of the injection log capability. Subject perception will also be evaluated by comparing the ease and convenience of use and subject preference for the easypodâ„¢ compared to two other rhGH pen injection devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 - Log Aware | Active Comparator | Dose Log Aware (patient is aware that the device records their injection information) Half the subjects in the log aware arm will complete a diary. The other half in the log aware arm will not complete the diary. |
|
| 2 - Log Unaware | Active Comparator | Dose Log Unaware (patient is not aware that the device records their injection information) Half the subjects in the log unaware arm will complete a diary. The other half in the log unaware arm will not complete the diary. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| easypod | Device | Subjects is aware that the device records injection information that can be viewed by user |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent rhGH Injections Missed During the Treatment Period (Based on the Easypodâ„¢ Injection Log) | 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects Perception of Easypod Ease of Use Compared to Two Other rhGH Pen Injection Devices | 90 Days | |
| Subject Perceptions of Easypod: Storage Convenience Compared to Two Other rhGH Pen Injection Devices. | 90 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible, MD | EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US Medical Information | Rockland | Massachusetts | 02370 | United States |
Screening and randomization took place at Visit 1 (Study Day 1) which consisted of informed consent, medical/disease history, physical exam and laboratory assessments.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Log Aware | Dose Log Aware and Daily Diary Enabled |
| FG001 | Log Unaware | Dose Log UnaAware and Daily Diary Disabled |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Log Aware | Dose Log Aware and Daily Diary Enabled |
| BG001 | Log Unaware | Dose Log UnaAware and Daily Diary Disabled |
| 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 | Percent rhGH Injections Missed During the Treatment Period (Based on the Easypodâ„¢ Injection Log) | 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. | Posted | May 2010 | Median | Full Range | Percent of injections missed | 90 Days |
|
Day 1, Week 12 and Four Week Follow-up
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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 | Log Aware | Dose Log Aware and Daily Diary Enabled |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Brainstem Tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
Enrollment ended early due to slow enrollment. Only 44 enrolled of the 100 subjects needed. Of the 44 enrolled, only 35 subjects had valid device data for analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sanja Dragnic, MD | EMD Serono, Inc. | 781-681-2337 | sanja.dragnic@emdserono.com |
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| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| easypod | Device | Subjects is not aware that the device records injection information that can be viewed by user |
|
| Subject Perceptions of Easypod: Preference to Use Easypod Over Two Other rhGH Pen Injection Devices. | 90 Days |
| 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 |
|
| Total |
|
|
|
| Secondary | Subjects Perception of Easypod Ease of Use Compared to Two Other rhGH Pen Injection Devices | 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. | Posted | May 2010 | Number | Participants | 90 Days |
|
|
|
| Secondary | Subject Perceptions of Easypod: Storage Convenience Compared to Two Other rhGH Pen Injection Devices. | 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. | Posted | May 2010 | Number | Participants | 90 Days |
|
|
|
| Secondary | Subject Perceptions of Easypod: Preference to Use Easypod Over Two Other rhGH Pen Injection Devices. | 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. | Posted | May 2010 | Number | Participants | 90 Days |
|
|
|
| 1 |
| 21 |
| 2 |
| 21 |
| EG001 | Log Unaware | Dose Log UnaAware and Daily Diary Disabled | 1 | 21 | 5 | 21 |
| Syncopal episodes | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Injection site haemorrhage | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Back Injury | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
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.
| 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 |
| Title | Measurements |
|---|---|
|
| Neutral |
|
| Disagree |
|
| Strongly Disagree |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Neutral |
|
| Not Very Convenient |
|
| Not at all Convenient |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Neutral |
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| Disagree |
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| Strongly Disagree |
|
| Missing |
|