TAK-633-4008: Quantitative Testing of Patient and Prescriber Knowledge, Attitudes, and Behavior about GATTEX (Teduglutide) for Injection Safety and Use Information (GATTEX KAB)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Knowledge, Attitude, Behavior Survey

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Survey

Study drug and medical condition

• Name of medicine, other:
  GATTEX
• Study drug International non-proprietary name (INN) or common name:
  TEDUGLUTIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (A16AX08) teduglutide

  teduglutide
• Medical condition to be studied:
  Short-bowel syndrome

Population studied

• Short description of the study population:
  Participants and prescriber who have completed Wave 7 of the GATTEX participant KAB Survey will be observed in this REMS survey.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  600

Study design details

• Main study objective:
  The main aim of this study is to document the level of knowledge and assess attitudes and behaviors of both participants and physicians regarding the risks and safe use of GATTEX. The survey will be done via internet, telephone, or paper and both physicians and participants will be able to choose the method that is preferred.
• Outcomes:
  Number of Participants and Prescribers Providing Correct Responses to Questions. Number of Participants and Prescribers Providing Correct Responses (80%) to and Demonstrated Understanding of Survey Knowledge Domains.
• Data analysis plan:
  Detailed statistical analysis methods will be conducted as described in the SAP for this study. Data will be summarized with tabulated descriptive statistics: number of observations, minimum, maximum, mean, median, standard deviation, and range for continuous variables and counts and percentages for categorical variables. In addition, graphical data displays will be used to summarize selected data.