A Safety and Tolerability Study of Paliperidone Palmitate Injected in the Shoulder or the Buttock Muscle in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00119756
First received: July 7, 2005
Last updated: June 6, 2011
Last verified: April 2010

July 7, 2005
June 6, 2011
June 2005
Not Provided
Safety evaluation (e.g. incidence of adverse events) between start and finish of the trial
Same as current
Complete list of historical versions of study NCT00119756 on ClinicalTrials.gov Archive Site
Pharmacokinetic evaluations (e.g. blood level of the drug) at finish of trial; Efficacy measures at finish of trial
  • Pharmacokinetic evaluations (e.g. blood level of the drug) at finish of trial
  • Efficacy measures at finish of trial
Not Provided
Not Provided
 
A Safety and Tolerability Study of Paliperidone Palmitate Injected in the Shoulder or the Buttock Muscle in Patients With Schizophrenia
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

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Schizophrenia
Drug: paliperidone palmitate
Not Provided
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. Epub 2009 May 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
253
November 2006
Not Provided

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00119756
CR002350
Not Provided
Not Provided
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Not Provided
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
April 2010

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