Phase 4
Completed N=114
Study to Measure the Safety of Paliperidone ER (Extended-release) in Patients With Liver Disease
Source: ClinicalTrials.gov NCT00535145 ↗Enrolled (actual)
114
Serious AEs
1.4%
Results posted
Sep 2013
Primary outcomePrimary: The Difference in the Incidence of Any Adverse Events When Patients Switch Their Antipsychotic From Treatment as Usual (TAU) to Paliperidone ER — 0; 2; 27; 43 Participants
Summary
The purpose of this study is to evaluate the tolerability and safety of paliperidone ER (extended-release) in doses between 3 milligrams per day and 12 milligrams per day in the treatment of patients with schizophrenia or schizoaffective disorder and liver disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Difference in the Incidence of Any Adverse Events When Patients Switch Their Antipsychotic From Treatment as Usual (TAU) to Paliperidone ER |
0; 2; 27; 43 | — |
| SECONDARY Positive and Negative Symptoms of Schizophrenia (PANSS) Change From Baseline |
-1.7; -5.4; -7.2; -7.6 | — |
| SECONDARY Clinical Global Impression of Severity (CGI-S) Change From Baseline |
-0.1; -0.1; -0.3; -0.4; -0.4 | — |
| SECONDARY Personal and Social Performance Score (PSP) Change From Baseline |
1.2; 2.8 | — |
Eligibility Criteria
Inclusion Criteria
- Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or agree to practice an effective method of birth control if they are sexually active before entry and throughout the study, and must also have a negative urine pregnancy test at Screening
- Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnosis of schizophrenia or schizoaffective disorder
- Must have identified current, stable liver disease (e.g., viral hepatitis, alcoholic cirrhosis)
- Child-Pugh class A or B (total score =10)
- No evidence of severe hepatic decompensation within the previous 3 months, such as: ascites not controlled with diuretics, peritonitis, portal hypertension or gross hepatic encephalopathy (eg, somnolence, stupor, coma)
Data sourced from ClinicalTrials.gov (NCT00535145). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.