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Convenience and preference for the new Mark VII pen compared to the current Genotropin pen will be assessed using a questionaire. it is expected that the new pen will be preferred or at least no different to the current pen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mark VII/Current pen | Other | Subject will use Mark VII pen for 2 months followed by Current pen for 2 months |
|
| Current pen/Mark VII | Other | Subject will use current Genotropin pen for 2 months followed by Mark VII pen for 2 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genotropin Pen | Device | Pen provided in 5, 5.3 and 12 mg doses, Dose based on body weight, subcutaneous injection daily for 2 months while in study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Dyads (Participant and Caregiver or Parent) and Adult Participants Reporting no Difference or Easier to Use for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen® | Participants were asked the following question from Section II of the Injection Pen Assessment Questionnaire (IPAQ) patient-reported outcome (PRO) tool, "Thinking about the Genotropin pen and the new injection pen you used over the past few months, please compare both injection pens and choose which one is easier to use overall?" Choices included: Genotropin Pen® easier to use, new injection pen easier to use, or no difference. | Month 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Dyads and Adult Participants Reporting no Preference or Preference for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen® | Participants were asked the following question from Section II of the IPAQ PRO tool, "Thinking about both injection pens over the past few months, please choose which injection pen you prefer overall." Choices included: prefer Genotropin Pen®, prefer new injection pen, or no preference. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fakultni Nemocnice Brno | Brno - Mesto | 61300 | Czechia | |||
| Fakultni nemocnice Olomouc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24748824 | Derived | Pleil AM, Darendeliler F, Dorr HG, Hutchinson K, Wollmann HA. Results from an international multicenter trial evaluating the ease-of-use of and preference for a newly developed disposable injection pen for the treatment of growth hormone deficiency in treatment-naive children and adults. Med Devices (Auckl). 2014 Apr 11;7:61-71. doi: 10.2147/MDER.S59821. eCollection 2014. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mark VII Pen Then Genotropin® Pen | Participant (not caregiver) used Mark VII pen (subcutaneous injections daily for 2 months) then the current Genotropin® pen (subcutaneous injections daily for 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin recombinant deoxyribonucleic acid [rDNA] origin); doses received by participants based on body weight. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention |
|
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| MARK VII pen | Device | Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study. |
|
| Genotropin Pen | Device | Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study. |
|
| MARK VII pen | Device | Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study. |
|
| Month 4 |
| Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Easier to Use Compared to the Genotropin Pen® | Participants were asked the following question from Section II of the IPAQ PRO tool, "Thinking about the Genotropin pen and the new injection pen you used over the past few months, please compare both injection pens and choose which one is easier to use overall?" Choices included: Genotropin Pen® easier to use, new injection pen easier to use, or no difference. | Month 4 |
| Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Preferable Compared to the Genotropin Pen® | Participants were asked the following question from Section II of the IPAQ PRO tool, "Thinking about both injection pens over the past few months, please choose which injection pen you prefer overall." Choices included: prefer Genotropin Pen®, prefer new injection pen, or no preference. | Month 4 |
| Percentage of Dyads and Adult Participants Who Would Choose the New Genotropin Mark VII Injection Pen in Preference to the Genotropin® Pen | Investigators were asked the following study treatment continuation question, "Which device did the participant choose for continued treatment?" Choices included the Genotropin® Pen or the new injection pen. | Month 4 |
| Ease of Use of Each Injection Pen | Participants were asked the following question from Section I of the IPAQ PRO tool, "Thinking about the injection pen you have been using for the past few months, how easy or difficult it is for you to use the injection pen overall?" Responses were provided using a 5 point scale which ranged from very easy (5), somewhat easy (4), neither easy nor difficult (3), somewhat difficult (2), or very difficult (1). | Month 2 and Month 4 |
| Olomouc |
| 775 20 |
| Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | 128 08 | Czechia |
| Fakultni nemocnice v Motole | Prague | 150 06 | Czechia |
| Vestische Kinder- und Jugendklinik Datteln | Datteln | 45711 | Germany |
| Universitaetsklinik fuer Kinder und Jugendliche | Erlangen | 91054 | Germany |
| Privatpraxis | Gauting | 82131 | Germany |
| Praxis fuer paediatrische Endokrinologie | Niederrad | 60528 | Germany |
| Privatpraxis | Oldenburg | 26122 | Germany |
| Sophia Kinderziekenhuis | Rotterdam | 3015 GD | Netherlands |
| Juliana Kinderziekenhuis / Endocrinologie | The Hague | Netherlands |
| Narodny endokrinologicky a diabetologicky ustav | Ľubochňa | Slovakia | 034 91 | Slovakia |
| Detska fakultna nemonica s poliklinikou, II. Detska klinika | Bratislava | 833 40 | Slovakia |
| Sahlgrenska Universitetssjukhuset, Centrum for Endokrinologi och Metabolism (CEM) | Gothenburg | 413 45 | Sweden |
| Drottning Silvias barn- och ungdomssjukhus, SU/Ostra | Gothenburg | 416 85 | Sweden |
| Barn och Ungdomsmedicinkliniken | Linköping | 581 85 | Sweden |
| Barnmedicinkliniken N | Umeå | 901 85 | Sweden |
| Ankara University Medical Faculty Department of Internal Diseases | Sihhiye | Ankara | 06100 | Turkey (Türkiye) |
| Istanbul University Istanbul Medical Faculty Department of Pediatric Health and Diseases | Çapa | Istanbul | 34390 | Turkey (Türkiye) |
| Salford Royal NHS Foundation Trust, Hope Hospital | Salford | Manchester | M6 8HD | United Kingdom |
| Royal Hospital for Sick Children | Glasgow | G3 8SJ | United Kingdom |
| St Thomas Hospital | London | SE1 7EH | United Kingdom |
| Norfolk and Norwich University Hospital | Norwich | NR4 7UY | United Kingdom |
| FG001 | Genotropin® Pen Then Mark VII Pen | Participant (not caregiver) used current Genotropin® pen (subcutaneous injections daily for 2 months) then the Mark VII pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Percentage of Dyads (Participant and Caregiver or Parent) and Adult Participants Reporting no Difference or Easier to Use for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen® | Participants were asked the following question from Section II of the Injection Pen Assessment Questionnaire (IPAQ) patient-reported outcome (PRO) tool, "Thinking about the Genotropin pen and the new injection pen you used over the past few months, please compare both injection pens and choose which one is easier to use overall?" Choices included: Genotropin Pen® easier to use, new injection pen easier to use, or no difference. | Full Analysis Set (FAS): randomized participants who used a study pen at least once to administer somatropin; Number of participants analyzed (N)= participants with evaluable data. Dyad defined as the participant (child being treated) and adult partner (parent or caregiver). | Posted | Number | 95% Confidence Interval | percentage of dyads, adult participants | Month 4 |
|
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| |||||||||||||||||||||||||
| Secondary | Percentage of Dyads and Adult Participants Reporting no Preference or Preference for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen® | Participants were asked the following question from Section II of the IPAQ PRO tool, "Thinking about both injection pens over the past few months, please choose which injection pen you prefer overall." Choices included: prefer Genotropin Pen®, prefer new injection pen, or no preference. | FAS | Posted | Number | 95% Confidence Interval | percentage of dyads, adult participants | Month 4 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Easier to Use Compared to the Genotropin Pen® | Participants were asked the following question from Section II of the IPAQ PRO tool, "Thinking about the Genotropin pen and the new injection pen you used over the past few months, please compare both injection pens and choose which one is easier to use overall?" Choices included: Genotropin Pen® easier to use, new injection pen easier to use, or no difference. | FAS; Number of participants analyzed (N)= participants with evaluable data | Posted | Number | 95% Confidence Interval | percentage of dyads, adult participants | Month 4 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Preferable Compared to the Genotropin Pen® | Participants were asked the following question from Section II of the IPAQ PRO tool, "Thinking about both injection pens over the past few months, please choose which injection pen you prefer overall." Choices included: prefer Genotropin Pen®, prefer new injection pen, or no preference. | FAS | Posted | Number | 95% Confidence Interval | percentage of dyads, adult participants | Month 4 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Dyads and Adult Participants Who Would Choose the New Genotropin Mark VII Injection Pen in Preference to the Genotropin® Pen | Investigators were asked the following study treatment continuation question, "Which device did the participant choose for continued treatment?" Choices included the Genotropin® Pen or the new injection pen. | FAS subset of participants located in areas where the new device was available. | Posted | Number | 95% Confidence Interval | percentage of dyads, adult participants | Month 4 |
|
| ||||||||||||||||||||||||||
| Secondary | Ease of Use of Each Injection Pen | Participants were asked the following question from Section I of the IPAQ PRO tool, "Thinking about the injection pen you have been using for the past few months, how easy or difficult it is for you to use the injection pen overall?" Responses were provided using a 5 point scale which ranged from very easy (5), somewhat easy (4), neither easy nor difficult (3), somewhat difficult (2), or very difficult (1). | FAS; Number of participants analyzed (N) = participants with evaluable data | Posted | Mean | Standard Deviation | scores on a scale | Month 2 and Month 4 |
|
|
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The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
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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 | Safety Population | All randomized participants who used a study pen (Genotropin® pen or the new Mark VII injection pen) at least once to administer Genotropin. | 2 | 120 | 48 | 120 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Application site pain | General disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Injection site injury | General disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v14.1 | Non-systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA v14.1 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA v14.1 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v14.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Attention deficit/hyperactivity disorder | Psychiatric disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v14.1 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA v14.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| 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 |
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| Title | Measurements |
|---|---|
|
| Between 45 and 64 years |
|
| ≥65 years |
|
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|
|
|
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| Counts |
|---|
| Participants |
|
|