Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects

NCT01112865 | Completed Phase 3 Results

• 1 other identifier: A6281297
• Study Type: interventional
• Target: 120
• Locations: 7 countries
• Sites: 23

Brief Summary

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.

Conditions

Growth Hormone Deficiency

Keywords

Growth Hormone Deficiency; Somatropin; Injection Pen; Medical Device; Cross Over Study; Preference; Convenience; Children; Dyads; Adults

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Percentage of Dyads and Adult Participants Reporting no Preference or Preference for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen®

  Month 4

• Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Easier to Use Compared to the Genotropin Pen®

  Month 4

• Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Preferable Compared to the Genotropin Pen®

  Month 4

• Percentage of Dyads and Adult Participants Who Would Choose the New Genotropin Mark VII Injection Pen in Preference to the Genotropin® Pen

  Month 4

• Ease of Use of Each Injection Pen

  Month 2 and Month 4

Study Arms (2)

Mark VII/Current pen

OTHER

Subject will use Mark VII pen for 2 months followed by Current pen for 2 months

Device: Genotropin Pen; Device: MARK VII pen

Current pen/Mark VII

OTHER

Subject will use current Genotropin pen for 2 months followed by Mark VII pen for 2 months

Device: Genotropin Pen; Device: MARK VII pen

Interventions

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.

Mark VII/Current pen

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.

Mark VII/Current pen

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 8 years.
• Subjects who are starting treatment with growth hormone (Genotropin) for the first time.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (23)

Fakultni Nemocnice Brno

Brno - Mesto, 61300, Czechia

Location

Fakultni nemocnice Olomouc

Olomouc, 775 20, Czechia

Location

Vseobecna fakultni nemocnice v Praze

Prague, 128 08, Czechia

Location

Fakultni nemocnice v Motole

Prague, 150 06, Czechia

Location

Vestische Kinder- und Jugendklinik Datteln

Datteln, 45711, Germany

Location

Universitaetsklinik fuer Kinder und Jugendliche

Erlangen, 91054, Germany

Location

Privatpraxis

Gauting, 82131, Germany

Location

Praxis fuer paediatrische Endokrinologie

Niederrad, 60528, Germany

Location

Privatpraxis

Oldenburg, 26122, Germany

Location

Sophia Kinderziekenhuis

Rotterdam, 3015 GD, Netherlands

Location

Juliana Kinderziekenhuis / Endocrinologie

The Hague, Netherlands

Location

Narodny endokrinologicky a diabetologicky ustav

Ľubochňa, Slovakia, 034 91, Slovakia

Location

Detska fakultna nemonica s poliklinikou, II. Detska klinika

Bratislava, 833 40, Slovakia

Location

Sahlgrenska Universitetssjukhuset, Centrum for Endokrinologi och Metabolism (CEM)

Gothenburg, 413 45, Sweden

Location

Drottning Silvias barn- och ungdomssjukhus, SU/Ostra

Gothenburg, 416 85, Sweden

Location

Barn och Ungdomsmedicinkliniken

Linköping, 581 85, Sweden

Location

Barnmedicinkliniken N

Umeå, 901 85, Sweden

Location

Ankara University Medical Faculty Department of Internal Diseases

Sihhiye, Ankara, 06100, Turkey (Türkiye)

Location

Istanbul University Istanbul Medical Faculty Department of Pediatric Health and Diseases

Çapa, Istanbul, 34390, Turkey (Türkiye)

Location

Salford Royal NHS Foundation Trust, Hope Hospital

Salford, Manchester, M6 8HD, United Kingdom

Location

Royal Hospital for Sick Children

Glasgow, G3 8SJ, United Kingdom

Location

St Thomas Hospital

London, SE1 7EH, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, NR4 7UY, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24748824 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

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; Endocrine System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2010
• First Posted: April 28, 2010
• Study Start: August 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: May 22, 2012
• Results First Posted: May 14, 2012

Record last verified: 2012-05

Locations

SE (4); GB (4); DE (5); SL (2); CZ (4); NL (2); TU (2)