Genotropin Study Assessing Use of Injection Pen

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00965484
• Collaborator: (none)
• Enrollment: 136
• Locations: 25
• Arm: 1
• Duration (Months): 3
• Patients Per Site: 5.4
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Growth Hormone Deficiency; Idiopathic Short Stature	Device: New Genotropin Pen	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 136 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multicenter, Open-Label Study Assessing Dyad (Subject And Caregiver) Perception Of Convenience And Preference Of The Newly Developed Mark VII Injection Pen
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Genotropin pen All subjects will receive genotropin pen to use for 2 months.	Device: New Genotropin Pen; 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

Outcome Measures

Primary Outcome Measures

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® [2 months]

   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).

Secondary Outcome Measures

1. 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]

   Preference for use measured using IPAQ PRO tool (ease of use and preference 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. Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Easier to Use Compared to Pre-study Experience With the Genotropin Pen® [2 months]

   Ease of use measured using the IPAQ PRO tool (ease of use and preference based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® Pen (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).

3. Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Preferable Compared to Pre-study Experience With the Genotropin Pen® [2 months]

   Preference for use measured using IPAQ PRO tool (ease of use and preference 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 8-18 years

• Using genotropin pen for at least 3 months prior to study enrollment

• Compliance with genotropin treatment

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Los Angeles	California	United States	90048
2	Pfizer Investigational Site	San Diego	California	United States	92123-4282
3	Pfizer Investigational Site	Greenwood Village	Colorado	United States	80111
4	Pfizer Investigational Site	Gainesville	Florida	United States	32608
5	Pfizer Investigational Site	Gainesville	Florida	United States	32610
6	Pfizer Investigational Site	Tallahassee	Florida	United States	32308
7	Pfizer Investigational Site	Indianapolis	Indiana	United States	46202
8	Pfizer Investigational Site	Baltimore	Maryland	United States	21201
9	Pfizer Investigational Site	Baltimore	Maryland	United States	21229
10	Pfizer Investigational Site	Southaven	Mississippi	United States	38671
11	Pfizer Investigational Site	Kansas City	Missouri	United States	64108
12	Pfizer Investigational Site	Morristown	New Jersey	United States	07962
13	Pfizer Investigational Site	Akron	Ohio	United States	44308
14	Pfizer Investigational Site	Columbus	Ohio	United States	43205
15	Pfizer Investigational Site	Philadelphia	Pennsylvania	United States	19107
16	Pfizer Investigational Site	Pittsburgh	Pennsylvania	United States	15218
17	Pfizer Investigational Site	Charleston	South Carolina	United States	29425
18	Pfizer Investigational Site	Florence	South Carolina	United States	29506
19	Pfizer Investigational Site	Memphis	Tennessee	United States	38105
20	Pfizer Investigational Site	Memphis	Tennessee	United States	38119
21	Pfizer Investigational Site	Dallas	Texas	United States	75230
22	Pfizer Investigational Site	Dallas	Texas	United States	75235
23	Pfizer Investigational Site	Fort Worth	Texas	United States	76104
24	Pfizer Investigational Site	San Antonio	Texas	United States	78229
25	Pfizer Investigational Site	Seattle	Washington	United States	98105

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00965484
• Other Study ID Numbers: A6281291
• First Posted: Aug 25, 2009
• Last Update Posted: Jan 28, 2011
• Last Verified: Apr 1, 2010

• Keywords provided by , ,: Genotropin Medical device Patient reported outcome
• Additional relevant MeSH terms: Dwarfism

Study Results

Participant Flow

Pre-assignment Detail	Participants who used the Genotropin® Pen for at least 3 months prior to enrollment were eligible to participate. Genotropin (somatropin) dose was not adjusted for the purposes of the study, but only based on clinical management requirements as determined by the treating physician.

Arm/Group Title	Genotropin / Genotropin Mark VII Pen
Arm/Group Description	Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
Period Title: Overall Study
STARTED	136
COMPLETED	134
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Genotropin / Genotropin Mark VII Pen
Arm/Group Description	Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
Overall Participants	136
Age, Customized (participants) [Number]
≤10 years of age	37 27.2%
Between 11 and 12 years of age	30 22.1%
Between 13 and 14 years of age	40 29.4%
≥15 years of age	29 21.3%
Sex: Female, Male (Count of Participants)
Female	45 33.1%
Male	91 66.9%

Outcome Measures

1. Primary Outcome

Title	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®
Description	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).
Time Frame	2 months

Outcome Measure Data

Analysis Population Description

Full analysis set (FAS): all participants who used the new pen at least once to administer Genotropin and who completed the 2-month follow-up questionnaire. Dyad defined as the participant (child being treated) and adult partner (parent or caregiver).

Arm/Group Title	Genotropin / Genotropin Mark VII Pen
Arm/Group Description	Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
Measure Participants	133
Number (95% Confidence Interval) [percentage of dyads]	73.68

2. Secondary Outcome

Title	Percentage of Dyads Reporting no Preference or Preference for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen®
Description	Preference for use measured using IPAQ PRO tool (ease of use and preference 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).
Time Frame	2 months

Outcome Measure Data

Analysis Population Description

FAS; N=number of participants with measurement.

Arm/Group Title	Genotropin / Genotropin Mark VII Pen
Arm/Group Description	Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
Measure Participants	132
Number (95% Confidence Interval) [percentage of dyads]	65.15

3. Secondary Outcome

Title	Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Easier to Use Compared to Pre-study Experience With the Genotropin Pen®
Description	Ease of use measured using the IPAQ PRO tool (ease of use and preference based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® Pen (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).
Time Frame	2 months

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Genotropin / Genotropin Mark VII Pen
Arm/Group Description	Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
Measure Participants	133
Number (95% Confidence Interval) [percentage of dyads]	63.16

4. Secondary Outcome

Title	Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Preferable Compared to Pre-study Experience With the Genotropin Pen®
Description	Preference for use measured using IPAQ PRO tool (ease of use and preference 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).
Time Frame	2 months

Outcome Measure Data

Analysis Population Description

FAS; number of participants with measurement.

Arm/Group Title	Genotropin / Genotropin Mark VII Pen
Arm/Group Description	Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
Measure Participants	132
Number (95% Confidence Interval) [percentage of dyads]	59.85

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Genotropin / Genotropin Mark VII Pen
Arm/Group Description	Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
All Cause Mortality
	Genotropin / Genotropin Mark VII Pen
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Genotropin / Genotropin Mark VII Pen
	Affected / at Risk (%)	# Events
Total	0/136 (0%)
Other (Not Including Serious) Adverse Events
	Genotropin / Genotropin Mark VII Pen
	Affected / at Risk (%)	# Events
Total	28/136 (20.6%)
Gastrointestinal disorders
Abdominal pain	1/136 (0.7%)
Abdominal pain upper	1/136 (0.7%)
Flatulence	1/136 (0.7%)
Toothache	1/136 (0.7%)
General disorders
Chills	1/136 (0.7%)
Influenza like illness	1/136 (0.7%)
Injection-site hematoma	3/136 (2.2%)
Injection-site pain	5/136 (3.7%)
Pyrexia	4/136 (2.9%)
Infections and infestations
Gastroenteritis viral	2/136 (1.5%)
Gastrointestinal viral infection	1/136 (0.7%)
Influenza	1/136 (0.7%)
Nasopharyngitis	1/136 (0.7%)
Pharyngitis streptococcal	3/136 (2.2%)
Sinusitis	1/136 (0.7%)
Staphylococcal infection	1/136 (0.7%)
Upper respiratory tract infection	4/136 (2.9%)
Injury, poisoning and procedural complications
Animal scratch	1/136 (0.7%)
Contusion	1/136 (0.7%)
Fall	1/136 (0.7%)
Joint sprain	1/136 (0.7%)
Limb injury	1/136 (0.7%)
Skin laceration	1/136 (0.7%)
Metabolism and nutrition disorders
Decreased appetite	1/136 (0.7%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/136 (0.7%)
Musculoskeletal pain	1/136 (0.7%)
Nervous system disorders
Headache	7/136 (5.1%)
Migraine	1/136 (0.7%)
Psychiatric disorders
Depression	1/136 (0.7%)
Insomnia	1/136 (0.7%)
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis	1/136 (0.7%)
Cough	2/136 (1.5%)
Nasal congestion	2/136 (1.5%)
Oropharyngeal pain	2/136 (1.5%)
Pulmonary congestion	1/136 (0.7%)
Rhinorrhoea	1/136 (0.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.