Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects (CHOOSE)
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01112865
First received: April 20, 2010
Last updated: May 15, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Growth Hormone Deficiency |
Device: Genotropin Pen Device: MARK VII pen |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter, Open-label, Randomized Two Arm Cross Over Study Assessing Dyad (Subject and Caregiver) and Adult Subject Perception of Convenience and Preference of the Newly Developed Genotropin Mark VII Pen. |
Resource links provided by NLM:
Genetics Home Reference related topics:
combined pituitary hormone deficiency
isolated growth hormone deficiency
metatropic dysplasia
pseudoachondroplasia
MedlinePlus related topics:
Caregivers
Drug Information available for:
Somatropin
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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® [ Time Frame: Month 4 ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Percentage of Dyads and Adult Participants Reporting no Preference or Preference for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen® [ Time Frame: Month 4 ] [ Designated as safety issue: No ]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.
- Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Easier to Use Compared to the Genotropin Pen® [ Time Frame: Month 4 ] [ Designated as safety issue: No ]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.
- Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Preferable Compared to the Genotropin Pen® [ Time Frame: Month 4 ] [ Designated as safety issue: No ]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.
- Percentage of Dyads and Adult Participants Who Would Choose the New Genotropin Mark VII Injection Pen in Preference to the Genotropin® Pen [ Time Frame: Month 4 ] [ Designated as safety issue: No ]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.
- Ease of Use of Each Injection Pen [ Time Frame: Month 2 and Month 4 ] [ Designated as safety issue: No ]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).
| Enrollment: | 120 |
| Study Start Date: | August 2010 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Mark VII/Current pen
Subject will use Mark VII pen for 2 months followed by Current pen for 2 months
|
Device: Genotropin Pen
Pen provided in 5, 5.3 and 12 mg doses, Dose based on body weight, subcutaneous injection daily for 2 months while in study.
Device: MARK VII pen
Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.
|
|
Current pen/Mark VII
Subject will use current Genotropin pen for 2 months followed by Mark VII pen for 2 months
|
Device: Genotropin Pen
Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.
Device: MARK VII pen
Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.
|
Eligibility| Ages Eligible for Study: | 4 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age greater than or equal to 8 years.
- Subjects who are starting treatment with growth hormone (Genotropin) for the first time.
Exclusion Criteria:
- Subjects with Prader-Willi syndrome or chronic renal insufficiency.
- Subjects and caregivers who, in the opinion of the investigator are not able to adequately participate in the study.
- Subjects with chronic systemic disorders, such as diabetes and heart disease.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112865
Locations
| Czech Republic | |
| Fakultni Nemocnice Brno | |
| Brno - mesto, Czech Republic, 61300 | |
| Fakultni nemocnice Olomouc | |
| Olomouc, Czech Republic, 775 20 | |
| Vseobecna fakultni nemocnice v Praze | |
| Praha 2, Czech Republic, 128 08 | |
| Fakultni nemocnice v Motole | |
| Praha 5, Czech Republic, 150 06 | |
| Germany | |
| Vestische Kinder- und Jugendklinik Datteln | |
| Datteln, Germany, 45711 | |
| Universitaetsklinik fuer Kinder und Jugendliche | |
| Erlangen, Germany, 91054 | |
| Praxis fuer paediatrische Endokrinologie | |
| Frankfurt-Niederrad, Germany, 60528 | |
| Privatpraxis | |
| Gauting, Germany, 82131 | |
| Privatpraxis | |
| Oldenburg, Germany, 26122 | |
| Netherlands | |
| Juliana Kinderziekenhuis / Endocrinologie | |
| Den Haag, Netherlands | |
| Sophia Kinderziekenhuis | |
| Rotterdam, Netherlands, 3015 GD | |
| Slovakia | |
| Detska fakultna nemonica s poliklinikou, II. Detska klinika | |
| Bratislava, Slovakia, 833 40 | |
| Narodny endokrinologicky a diabetologicky ustav | |
| Lubochna, Slovakia, 034 91 | |
| Sweden | |
| Sahlgrenska Universitetssjukhuset, Centrum for Endokrinologi och Metabolism (CEM) | |
| Goteborg, Sweden, 413 45 | |
| Drottning Silvias barn- och ungdomssjukhus, SU/Ostra | |
| Goteborg, Sweden, 416 85 | |
| Barn och Ungdomsmedicinkliniken | |
| Linkoping, Sweden, 581 85 | |
| Barnmedicinkliniken N | |
| Umea, Sweden, 901 85 | |
| Turkey | |
| Ankara University Medical Faculty Department of Internal Diseases | |
| Sihhiye, Ankara, Turkey, 06100 | |
| Istanbul University Istanbul Medical Faculty Department of Pediatric Health and Diseases | |
| Capa, Istanbul, Turkey, 34390 | |
| United Kingdom | |
| Salford Royal NHS Foundation Trust, Hope Hospital | |
| Salford, Manchester, United Kingdom, M6 8HD | |
| Royal Hospital for Sick Children | |
| Glasgow, United Kingdom, G3 8SJ | |
| St Thomas Hospital | |
| London, United Kingdom, SE1 7EH | |
| Norfolk and Norwich University Hospital | |
| Norwich, United Kingdom, NR4 7UY | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01112865 History of Changes |
| Other Study ID Numbers: | A6281297 |
| Study First Received: | April 20, 2010 |
| Results First Received: | April 16, 2012 |
| Last Updated: | May 15, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Pfizer:
|
Growth Hormone Deficiency Somatropin Injection Pen Medical Device Cross Over Study |
Preference Convenience Children Dyads Adults |
Additional relevant MeSH terms:
|
Dwarfism, Pituitary Endocrine System Diseases Dwarfism Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Bone Diseases, Endocrine |
Hypopituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013