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Zyprexa® Relprevv™ Patient Care Program

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ClinicalTrials.gov Identifier: NCT01088386
Recruitment Status : Enrolling by invitation
First Posted : March 17, 2010
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
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).

Condition or disease
Schizophrenia

Detailed Description:

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.

Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Zyprexa® Relprevv™ Patient Care Program
Study Start Date : March 2010
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
U.S. FDA Resources

Group/Cohort
Patients
All patients who will be receiving Zyprexa Relprevv must be enrolled into the Zyprexa Relprevv Patient Care Program



Primary Outcome Measures :
  1. Incidence per injection and per patient of post-injection delirium/sedation syndrome (PDSS) events [ Time Frame: Baseline to end of study ]

Secondary Outcome Measures :
  1. Type of post-injection delirium/sedation syndrome (PDSS) by clinical presentation and outcome [ Time Frame: Baseline to end of study ]
  2. Potential risk factors of post-injection delirium/sedation syndrome (PDSS). [ Time Frame: Baseline to end of study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Clinical practices in the United States
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Any patient not receiving Zyprexa Relprevv

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01088386


Locations
United States, Pennsylvania
United BioSource Corporation
Blue Bell, Pennsylvania, United States, 19422
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01088386     History of Changes
Other Study ID Numbers: 12991
F1D-MC-B041 ( Other Identifier: Eli Lilly and Company )
First Posted: March 17, 2010    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents