1/30/2020
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`History of Changes for Study: NCT00119756
`
`History of Changes for Study: NCT00119756
`
`A Safety and Tolerability Study of Paliperidone Palmitate Injected in the Shoulder or the Buttock
`Muscle in Patients With Schizophrenia
`
`Latest version (submitted June 6, 2011) on ClinicalTrials.gov
`
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`Side format only applies to the Protocol section of the study.
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`Study Record Versions
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`Version
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`A
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`B
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`Submitted Date
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`Changes
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`July 7, 2005 None (earliest Version on record)
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`July 13, 2005 Study Status
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`October 21, 2005 Recruitment Status, Study Status, Outcome Measures, Contacts/Locations, Eligibility,
`Study Design and Study Description
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`December 2, 2005 Contacts/Locations and Study Status
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`March 3, 2006 Contacts/Locations, Study Status and Eligibility
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`March 31, 2006 Contacts/Locations and Study Status
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`April 28, 2006 Study Status
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`May 26, 2006 Contacts/Locations and Study Status
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`July 3, 2006 Study Status and Contacts/Locations
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`July 28, 2006 Recruitment Status, Study Status and Contacts/Locations
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`March 17, 2008 Recruitment Status, Study Status, Study Design and Oversight
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`August 27, 2009 Study Design, Study Status, References, Contacts/Locations and Study Description
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`https://clinicaltrials.gov/ct2/history/NCT00119756?V_10=View#StudyPageTop
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`1/30/2020
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`History of Changes for Study: NCT00119756
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`Version
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`A
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`B
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`Submitted Date
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`Changes
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`13
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`14
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`15
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`November 19, 2009 Study Status
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`April 26, 2010 Study Status
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`June 6, 2011 References and Study Status
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`Compare
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`
`Study NCT00119756
`Submitted Date: July 28, 2006 (v10)
`
`Study Identification
`Unique Protocol ID: CR002350
`Brief Title: A Safety and Tolerability Study of Paliperidone Palmitate Injected in the Shoulder or
`the Buttock Muscle in Patients With Schizophrenia
`Official Title: A Randomized, Crossover Study to Evaluate the Overall Safety and Tolerability of
`Paliperidone Palmitate Injected in the Deltoid or Gluteus Muscle in Patients With
`Schizophrenia
`
`Secondary IDs:
`
`Study Status
`
`Record Verification: July 2006
`Overall Status: Active, not recruiting
`Study Start: June 2005
`Primary Completion:
`Study Completion:
`
`First Submitted: July 7, 2005
`First Submitted that
`July 7, 2005
`Met QC Criteria:
`First Posted: July 14, 2005 [Estimate]
`
`July 28, 2006
`
`Last Update Submitted that
`Met QC Criteria:
`Last Update Posted: July 31, 2006 [Estimate]
`Sponsor/Collaborators
`
`Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
`Responsible Party:
`Collaborators:
`
`Oversight
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`https://clinicaltrials.gov/ct2/history/NCT00119756?V_10=View#StudyPageTop
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`History of Changes for Study: NCT00119756
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`U.S. FDA-regulated Drug:
`U.S. FDA-regulated Device:
`Data Monitoring:
`Study Description
`Brief Summary: The purpose of this study is to evaluate the safety and tolerability of intramuscular
`injections (to the buttocks or to the shoulders) of paliperidone palmitate in patients with
`schizophrenia.
`Detailed Description: To date, all prior trials involving intramuscular injection of paliperidone palmitate were
`conducted with buttock administration. This is a randomized, multicenter, crossover
`design study in evaluating safety and tolerability of paliperidone palmitate in two
`different injection sites. The study hypothesis is that there will be no difference in
`safety and tolerability between buttock injection compared to shoulder injection at any
`of the three different doses of paliperidone palmitate.
`
`The patients will receive intramuscular injections of paliperidone palmitate in either
`their buttocks or in their shoulders
`
`Conditions
`
`Study Design
`
`Conditions: Schizophrenia
`Keywords: Intramuscular injection
`Gluteus muscle
`Schizophrenia
`Paliperidone palmitate
`Deltoid muscle
`
`Study Type: Interventional
`Primary Purpose: Treatment
`Study Phase: Phase 3
`Interventional Study Model: Crossover Assignment
`Number of Arms:
`Masking: Double (masked roles unspecified)
`Allocation: Randomized
`Enrollment: 282
`Arms and Interventions
`Intervention Details:
`Drug: paliperidone palmitate
`Outcome Measures
`Primary Outcome Measures:
`1. Safety evaluation (e.g. incidence of adverse events) between start and finish of the trial
`Secondary Outcome Measures:
`2. Pharmacokinetic evaluations (e.g. blood level of the drug) at finish of trial; Efficacy measures at finish of trial
`Eligibility
`
`https://clinicaltrials.gov/ct2/history/NCT00119756?V_10=View#StudyPageTop
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`History of Changes for Study: NCT00119756
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`Minimum Age: 18 Years
`Maximum Age:
`Sex: All
`Gender Based:
`Accepts Healthy Volunteers: No
`Criteria: Inclusion Criteria:
`
`The patient must have signed an informed consent
`The patient must meet the diagnostic criteria for schizophrenia
`Female patient must be postmenopausal for at least 2 years or have negative
`pregnancy test result at screening
`The patient must be able to perform study requirements (e.g. answer
`questionnaire)
`
`Exclusion Criteria:
`
`Primary, active diagnosis other than schizophrenia
`Psychiatric inpatient hospitalization for relapse of symptoms of schizophrenia in
`the past 90 days
`Change in their antipsychotic medication in the past 45 days
`Diagnosis of active substance dependence within 3 months
`History of treatment resistance
`History of concurrent significant or unstable diseases (e.g. heart, lung, or liver
`diseases)
`
`Contacts/Locations
`Study Officials: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial
`Study Director
`Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
`
`Locations:
`
`Plan to Share IPD:
`
`IPDSharing
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`References
`
`Citations: Hough D, Lindenmayer JP, Gopal S, Melkote R, Lim P, Herben V, Yuen E, Eerdekens
`M. Safety and tolerability of deltoid and gluteal injections of paliperidone palmitate in
`schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2009 Aug 31;33(6):1022-
`31. doi: 10.1016/j.pnpbp.2009.05.014. Epub 2009 May 28. PubMed 19481579
`
`Links:
`Available IPD/Information:
`
`Scroll up to access the controls
`
`Scroll to the Study top
`
`U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services
`
`https://clinicaltrials.gov/ct2/history/NCT00119756?V_10=View#StudyPageTop
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