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 PE

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK0 个研究点目标入组 130 人开始时间: 2010年7月30日最近更新: 2017年10月2日

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•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

•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.

发起方

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK