Zyprexa® Relprevv™ Patient Care Program

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01088386
First received: March 15, 2010
Last updated: September 20, 2012
Last verified: September 2012

March 15, 2010
September 20, 2012
March 2010
May 2016   (final data collection date for primary outcome measure)
Incidence per injection and per patient of post-injection delirium/sedation syndrome (PDSS) events [ Time Frame: Baseline to end of study ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01088386 on ClinicalTrials.gov Archive Site
  • Type of post-injection delirium/sedation syndrome (PDSS) by clinical presentation and outcome [ Time Frame: Baseline to end of study ] [ Designated as safety issue: Yes ]
  • Potential risk factors of post-injection delirium/sedation syndrome (PDSS). [ Time Frame: Baseline to end of study ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Zyprexa® Relprevv™ Patient Care Program
Zyprexa® Relprevv™ Patient Care Program

The goal of the Zyprexa Relprevv Patient Care Program is to mitigate the risk of negative outcomes associated with Zyprexa Relprevv post-injection delirium/sedation syndrome (PDSS).

The goal of the Zyprexa Relprevv Patient Care Program is to mitigate the risk of negative outcomes associated with Zyprexa Relprevv post-injection delirium/sedation syndrome (PDSS) by:

  1. Ensuring Zyprexa Relprevv is prescribed only by certified prescribers, dispensed only by certified dispensers, and dispensed for use only in certified healthcare facilities with ready access to emergency response services, and dispensed for use only with documentation of safe use conditions;
  2. Informing health care providers and patients about the risks and the need for continuous observation of patients for at least 3 hours in certified healthcare facilities; and
  3. Establishing long-term safety and safe use of Zyprexa Relprevv through periodic monitoring for the risk of PDSS events and by enrolling all patients who receive Zyprexa Relprevv in the Zyprexa Relprevv Patient Care Program registry.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Clinical practices in the United States

Schizophrenia
Not Provided
Patients
All patients who will be receiving Zyprexa Relprevv must be enrolled into the Zyprexa Relprevv Patient Care Program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
4000
May 2016
May 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Any patients receiving Zyprexa Relprevv enrolled in Zyprexa Relprevv Patient Care Program

Exclusion Criteria:

  • Any patient not receiving Zyprexa Relprevv
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01088386
12991, F1D-MC-B041
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP