NCT00965484

Brief Summary

Assessment of Genotropin patient and caregiver (Dyad) perception of convenience and preference of Genotropin injection pen. Patients already on genotropin will be asked to use a genotropin pen for 2 months. Patient and caregiver will be asked to complete a questionnaire at baseline and 2 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
12 months until next milestone

Results Posted

Study results publicly available

December 23, 2010

Completed
Last Updated

January 28, 2011

Status Verified

April 1, 2010

Enrollment Period

3 months

First QC Date

August 21, 2009

Results QC Date

December 2, 2010

Last Update Submit

January 26, 2011

Conditions

Growth Hormone DeficiencyIdiopathic Short Stature

Keywords

Genotropin Medical device Patient reported outcome

Outcome Measures

Primary Outcomes (1)

  • Percentage of Dyads (Participant and Caregiver or Parent) Reporting no Difference or Easier to Use for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen®

    Ease of use measured using the Injection Pen Assessment Questionnaire (IPAQ) patient-reported outcome (PRO) tool (based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference).

    2 months

Secondary Outcomes (3)

  • Percentage of Dyads Reporting no Preference or Preference for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen®

    2 months

  • Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Easier to Use Compared to Pre-study Experience With the Genotropin Pen®

    2 months

  • Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Preferable Compared to Pre-study Experience With the Genotropin Pen®

    2 months

Study Arms (1)

Genotropin pen

EXPERIMENTAL

All subjects will receive genotropin pen to use for 2 months.

Device: New Genotropin Pen

Interventions

New Genotropin PenDEVICE

Subjects will use the genotropin pen for 2 months. After 2 months patients and caregiver will be asked to fill out a questionnaire to assess perception of the genotropin pen

Genotropin pen

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 8-18 years
  • Using genotropin pen for at least 3 months prior to study enrollment
  • Compliance with genotropin treatment

You may not qualify if:

  • Medical conditions that can affect participation in study
  • Insufficient command of English language to understand questionnaire
  • Using other growth hormone device and not Genotropin pen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Pfizer Investigational Site

Los Angeles, California, 90048, United States

Location

Pfizer Investigational Site

San Diego, California, 92123-4282, United States

Location

Pfizer Investigational Site

Greenwood Village, Colorado, 80111, United States

Location

Pfizer Investigational Site

Gainesville, Florida, 32608, United States

Location

Pfizer Investigational Site

Gainesville, Florida, 32610, United States

Location

Pfizer Investigational Site

Tallahassee, Florida, 32308, United States

Location

Pfizer Investigational Site

Indianapolis, Indiana, 46202, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21201, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21229, United States

Location

Pfizer Investigational Site

Southaven, Mississippi, 38671, United States

Location

Pfizer Investigational Site

Kansas City, Missouri, 64108, United States

Location

Pfizer Investigational Site

Morristown, New Jersey, 07962, United States

Location

Pfizer Investigational Site

Akron, Ohio, 44308, United States

Location

Pfizer Investigational Site

Columbus, Ohio, 43205, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19107, United States

Location

Pfizer Investigational Site

Pittsburgh, Pennsylvania, 15218, United States

Location

Pfizer Investigational Site

Charleston, South Carolina, 29425, United States

Location

Pfizer Investigational Site

Florence, South Carolina, 29506, United States

Location

Pfizer Investigational Site

Memphis, Tennessee, 38105, United States

Location

Pfizer Investigational Site

Memphis, Tennessee, 38119, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75230, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75235, United States

Location

Pfizer Investigational Site

Fort Worth, Texas, 76104, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78229, United States

Location

Pfizer Investigational Site

Seattle, Washington, 98105, United States

Location

Related Publications (1)

  • Hey-Hadavi J, Pleil A, Deeb LC, Fuqua JS, Silverman LA, Reiner B, Newfield R, Rajicic N, Wajnrajch MP, Cara JF. Ease of use and preference for a new disposable self-injection pen compared with a reusable pen for administering recombinant human growth hormone: A multicenter, 2-month, single-arm, open-label clinical trial in patient-caregiver dyads. Clin Ther. 2010 Nov;32(12):2036-47. doi: 10.1016/j.clinthera.2010.11.007.

    PMID: 21118739DERIVED

Related Links

MeSH Terms

Conditions

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine 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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 21, 2009

First Posted

August 25, 2009

Study Start

October 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

January 28, 2011

Results First Posted

December 23, 2010

Record last verified: 2010-04

Locations

US(25)