Easypod United States User Trial

NCT00689260 | Completed Phase 4 Results

• 1 other identifier: 28358
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study will help to determine whether an injection log on a recombinant human growth hormone (rhGH) delivery device improves subjects' adherence with injection schedules. Adherence will be compared between a group of subjects who are aware of the injection log on the easypod™ rhGH delivery device and a group of subjects who are not aware of the easypod™ injection log. It is the study hypothesis that subject non-adherence rate is different for those who are aware of the injection log capability versus those who are unaware of the injection log capability. Subject perception will also be evaluated by comparing the ease and convenience of use and subject preference for the easypod™ compared to two other rhGH pen injection devices.

Conditions

Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

• Percent rhGH Injections Missed During the Treatment Period (Based on the Easypod™ Injection Log)

  90 Days

Secondary Outcomes (3)

• Subjects Perception of Easypod Ease of Use Compared to Two Other rhGH Pen Injection Devices

  90 Days

• Subject Perceptions of Easypod: Storage Convenience Compared to Two Other rhGH Pen Injection Devices.

  90 Days

• Subject Perceptions of Easypod: Preference to Use Easypod Over Two Other rhGH Pen Injection Devices.

  90 Days

Study Arms (2)

1 - Log Aware

ACTIVE COMPARATOR

Dose Log Aware (patient is aware that the device records their injection information) Half the subjects in the log aware arm will complete a diary. The other half in the log aware arm will not complete the diary.

Device: easypod

2 - Log Unaware

ACTIVE COMPARATOR

Dose Log Unaware (patient is not aware that the device records their injection information) Half the subjects in the log unaware arm will complete a diary. The other half in the log unaware arm will not complete the diary.

Device: easypod

Interventions

easypod DEVICE

Subjects is aware that the device records injection information that can be viewed by user

1 - Log Aware

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Be male or female from 10 to 18 years of age, inclusive, with open epiphyses
• Have GH deficiency diagnosed by treating pediatric endocrinologist for at least 6 months
• Be undergoing rhGH treatment via self-injection using the Lilly Humatrope® or Pfizer Genotropin® pen injection device for at least 6 months
• Be willing and able to comply with the protocol for the duration of the trial
• Have access to the Internet
• Be able to read, speak and understand English
• If female of childbearing potential, have a negative urine pregnancy test at Screening and use an acceptable form of birth control during the trial, including abstinence, a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide

You may not qualify if:

• Known allergy or hypersensitivity to rhGH or prescribed diluent (0.3% metacresol for click.easy® cartridge)
• Severe illness during the previous 6 months
• Active malignancy (except non-melanomatous skin malignancies)
• Diabetes mellitus (type I or II)
• Pregnancy or lactation
• Any medical condition that, in the opinion of the Investigator, would jeopardize the subject's safety following exposure to the investigational device
• Participation in any other investigational study during the duration of participation in this trial

Sponsors & Collaborators

• EMD Serono: lead

Study Sites (1)

US Medical Information

Rockland, Massachusetts, 02370, United States

Location

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

Limitations and Caveats

Enrollment ended early due to slow enrollment. Only 44 enrolled of the 100 subjects needed. Of the 44 enrolled, only 35 subjects had valid device data for analysis.

Results Point of Contact

• Title: Sanja Dragnic, MD
• Organization: EMD Serono, Inc.

sanja.dragnic@emdserono.com

781-681-2337

Study Officials

• Medical Responsible, MD

  EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2008
• First Posted: June 3, 2008
• Study Start: March 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: October 1, 2009
• Last Updated: May 15, 2015
• Results First Posted: July 20, 2010

Record last verified: 2015-04

Locations

US (1)