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

• Register: EUCTR
• Last refreshed on: 31 July 2012
• Main ID: EUCTR2009-017354-12-SE
• Date of registration: 09/04/2010
• Prospective Registration: Yes
• Primary sponsor: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
• Public 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
• Scientific 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
• Date of first enrolment: 11/10/2010
• Target sample size: 130
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-017354-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Czech Republic, Germany, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1. Age = 4 years.
2. Subjects who are starting treatment with growth hormone (Genotropin) for the first time.
3. Written informed consent of the adult member of the subject dyad or legally authorized representative (ie, Parent/Legal Guardian) indicating that the subject and the legally acceptable representative have been informed of all pertinent aspects of the study. In addition if possible, assent should be obtained from the child to take part in the study. The adult member of the dyad will be consenting for his/her participation. For adult subjects evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
4. Subjects who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
5. Female Genotropin users of child bearing potential must have a negative urine pregnancy test at screening. They should use adequate and reliable birth control methods during the study period.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subjects presenting with any of the following will not be included in the trial:
1. Subjects with Prader-Willi syndrome or chronic renal insufficiency.
2. Subjects and caregivers who, in the opinion of the investigator are not able to adequately participate in the study.
3. Subjects with chronic systemic disorders, such as diabetes and heart disease.
4. Subjects who are not able to understand written and/or verbal instructions on the proper use of the growth hormone injection devices.
5. Subjects who are not able to able or willing to complete the questionnaires used for the study assessments.
6. Subjects who have previously used other growth hormone injection devices including the current Genotropin Pen.
7. Subjects who previously participated in any of the Genotropin Mark VII development research and studies.
8. Subjects who are participating in any interventional clinical studies.
9. Subjects who are taking concomitant investigational drugs/treatment.
10. Subjects who, in the opinion of the investigator, are not likely to comply with the study requirements for any reason.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Subjects with Growth Hormone Deficiency
MedDRA version: 12.1 Level: LLT Classification code 10056438 Term: Growth hormone deficiency

Intervention(s)

Product Name: Genotropin Mark VII pen
Product Code: PN-180307
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Somatropin
CAS Number: n/a
Current Sponsor code: Genotropin
Other descriptive name: n/a
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Product Name: Genotropin Mark VII pen
Product Code: PN-180307
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Somatropin
CAS Number: n/a
Current Sponsor code: Genotropin
Other descriptive name: n/a
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5.3-

Product Name: Genotropin Mark VII pen
Product Code: PN-180307
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Somatropin
CAS Number: n/a
Current Sponsor code: Genotropin
Other descriptive name: n/a
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12-

Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: SOMATROPIN
CAS Number: 12629-01-5
Current Sponsor code: Genotropin
Other descriptive name: n/a
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: SOMATROPIN
CAS Number: 12629-01-5
Current Sponsor code: Genotropin
Other descriptive name: n/a
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5.3-

Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: SOMATROPIN
CAS Number: 12629-01-5
Current Sponsor code: Genotropin
Other descriptive name: n/a
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12-

Primary Outcome(s)

Secondary Objective: To evaluate the subject preference for the new Genotropin Mark VII pen compared with the current Genotropin Pen.

Primary end point(s): Proportion of dyads and adult subjects that reported the Genotropin Mark VII pen as no different or easier to use compared the current Genotropin Pen

Main Objective: To evaluate the ease of use/convenience of the new Genotropin Mark VII pen compared to the current Genotropin Pen.

Secondary ID(s)

A6281297