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Zyprexa® Relprevv™ Patient Care Program

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01088386
First Posted: March 17, 2010
Last Update Posted: December 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
March 15, 2010
March 17, 2010
December 8, 2017
March 2010
May 2021   (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 ]
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 ]
  • Potential risk factors of post-injection delirium/sedation syndrome (PDSS). [ Time Frame: Baseline to end of study ]
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 2021
May 2021   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01088386
12991
F1D-MC-B041 ( Other Identifier: Eli Lilly and Company )
No
Not Provided
Not Provided
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
December 2017