Navigation Links
Phase III Study Demonstrates INVEGA(R) SUSTENNA(TM) (paliperidone palmitate) Statistically Similar to RISPERDAL(R) CONSTA(R) (risperidone) Long-Acting Injection
Date:12/10/2009

A was non-inferior to RISPERDAL CONSTA in the treatment of schizophrenia in this trial, which validates that these are both good options," said George Simpson, M.D., professor of research at Keck School of Medicine, University of Southern California and clinical investigator for the INVEGA SUSTENNA program. "The differences between the two products, such as the shorter or longer dosing interval or the need for oral supplementation, provide options for physicians to decide what will work best for an individual patient."

About the Study

The 13-week, randomized, double-blind, double-dummy trial included 1220 adults with a diagnosis of schizophrenia and a PANSS total score of 60 to 120. Participants were randomly assigned to receive INVEGA SUSTENNA (IS) plus oral placebo or RISPERDAL CONSTA (RC) plus oral risperidone for the first three weeks.

Patients assigned to IS received an initiation dosing regimen of 234* mg on day 1 and 156 mg on day 8, followed by once-monthly dosing on day 36 (78 mg or 156 mg) and day 64 (78 mg, 156 mg, or 234 mg). Additional placebo injections were administered to match RC dosing. Patients assigned to RC received their first injection on day 8, followed by biweekly injections on day 22, 36, 50, 64 and 78. This was supplemented with placebo injections to match IS dosing. The 25 mg starting dose of RC could have been increased up to 37.5 mg starting on day 36 and up to 50 mg on day 64. Patients on RC received mandatory oral risperidone supplementation from days 1 to 28. Oral supplementation was optional with subsequent dose increases.

The primary endpoint of the trial was the change in the PANSS total score versus baseline. Non-inferiority would be concluded by calculation using a 95% confidence interval (CI) based on a pre-specified change in total PANSS score. Secondary efficacy measures included change from baseline for Clinical Global Impression-Severity (CGI-S) and Personal and Social Pe
'/>"/>

SOURCE Janssen(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10

Related medicine technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. Thomson Scientific Publishes The Ones to Watch - A Quarterly Review of Phase Changes in the Pharmaceutical Pipeline
3. Progen Engages Leading CRO to Assist with Phase 3 Trial of PI-88
4. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
5. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
6. Multiple Myeloma Research Consortium (MMRC) Partners with Novartis to Advance Phase II Study of Deacetylase Inhibitor
7. Positive Kuvan(TM) Pivotal Phase 3 Trial Results Published in The Lancet
8. Potential Safety Issue Identified in Ongoing Phase 2 Clinical Study of HCV-796
9. TaiGen Biotechnology Successfully Completes Patient Recruitment for Phase II Trial of Nemonoxacin for Treatment of Adult Community Acquired Pneumonia (CAP)
10. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
11. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/2/2014)... 2, 2014 Perrigo Company plc, a public limited ... (the " Company "), today announced that it is ... its new 1.30% Senior Notes due 2016 (the " 2016 ... due 2018 (the " 2018 Exchange Notes "), $800,000,000 of ... Exchange Notes ") and $400,00,000 of its new 5.30% Senior ...
(Date:9/2/2014)... 2, 2014  XBiotech announced today interim results ... in the US for its anti-cancer agent Xilonix™. ... therapy, is being evaluated in advanced colorectal cancer ... The primary endpoint of the study is overall ... a control population provided only palliative therapy for ...
(Date:9/2/2014)... Sept. 2, 2014 Reportlinker.com announces that ... its catalogue: Acute Heart Failure Global ... http://www.reportlinker.com/p0689743/Acute-Heart-Failure-Global-Clinical-Trials-Review-H2-2014.html Acute Heart Failure ... Summary GlobalData,s clinical trial report, "Acute Heart ... data on the Acute Heart Failure clinical trial ...
Breaking Medicine Technology:Perrigo Company plc Announces Exchange Offer For Its 1.30% Senior Notes Due 2016, 2.30% Senior Notes Due 2018, 4.00% Senior Notes Due 2023 and 5.30% Senior Notes Due 2043 2Perrigo Company plc Announces Exchange Offer For Its 1.30% Senior Notes Due 2016, 2.30% Senior Notes Due 2018, 4.00% Senior Notes Due 2023 and 5.30% Senior Notes Due 2043 3Perrigo Company plc Announces Exchange Offer For Its 1.30% Senior Notes Due 2016, 2.30% Senior Notes Due 2018, 4.00% Senior Notes Due 2023 and 5.30% Senior Notes Due 2043 4XBiotech Halts Study, Reports Positive Phase III Results with Antibody Therapy for Cancer 2Acute Heart Failure Global Clinical Trials Review, H2, 2014 2Acute Heart Failure Global Clinical Trials Review, H2, 2014 3Acute Heart Failure Global Clinical Trials Review, H2, 2014 4Acute Heart Failure Global Clinical Trials Review, H2, 2014 5Acute Heart Failure Global Clinical Trials Review, H2, 2014 6Acute Heart Failure Global Clinical Trials Review, H2, 2014 7Acute Heart Failure Global Clinical Trials Review, H2, 2014 8
... March 7, 2011 Ajinomoto Co., a leader ... safe, effective nutraceutical solutions, has announced that its ... federal trademark registration, (®), on the Principal Register ...  The trademark is the latest milestone for Capsiate ...
... 7, 2011 HGI Global Holdings, Inc., a leading ... today announced the appointment of Michael B. Petras, Jr. ... Mr. Petras, 43, joins HGI from GE Lighting, ... (NYSE: GE ) where he served as ...
Cached Medicine Technology:Ajinomoto Co.'s Capsiate Natura® Reaches New Milestone 2Michael Petras, Former CEO of GE Lighting, Named CEO of Cleveland-Based Specialty Medical Supplies Leader 2Michael Petras, Former CEO of GE Lighting, Named CEO of Cleveland-Based Specialty Medical Supplies Leader 3
(Date:9/2/2014)... September 02, 2014 The Wm. Jennings Bryan ... and public town hall meeting for Veterans and their families ... the outreach fair to provide Veterans with valuable healthcare and ... town hall will provide a forum where we can gather ... , The outreach fair will be held 4:45 p.m. to ...
(Date:9/2/2014)... Essen, Germany, September 2, 2014 In a ... Germany, researchers found that mild cognitive impairment (MCI) ... diabetes mellitus type 2. Interestingly, this strong association ... whereas in older participants (66-80 years) the association ... Journal of Alzheimer,s Disease . , The concept ...
(Date:9/2/2014)... Operators in the Community Services ... annually, arranging care and counsel for those in need. ... expected to derive $39.4 billion in revenue, which includes ... Over the five years through 2014-15, the subdivision is ... including growth of 4.1% in 2014-15. , As the ...
(Date:9/2/2014)... Steven Reinberg HealthDay Reporter ... device intended to help with weight loss by blocking a ... expectations in a trial among obese patients. Using electric ... brain and stomach, researchers hoped to suppress feelings of hunger. ... "A device that safely blocks the nerve that connects ...
(Date:9/2/2014)... locations with less intensive (and expensive) practice patterns appear ... spare patients unnecessary and excessive medical care, according to ... , "Growing concern about the costs and harms of ... to avoid the provision of unnecessary care," said lead ... The Dartmouth Institute for Health Policy & Clinical ...
Breaking Medicine News(10 mins):Health News:Diabetes mellitus and mild cognitive impairment: Higher risk in middle age? 2Health News:Community Services in Australia Industry Market Research Report Now Updated by IBISWorld 2Health News:Community Services in Australia Industry Market Research Report Now Updated by IBISWorld 3Health News:Nerve Blocking Procedure Fails to Impress in Weight Loss Study 2Health News:Nerve Blocking Procedure Fails to Impress in Weight Loss Study 3Health News:Residency training predicts physicians' ability to practice conservatively 2
... within the Academy of Finland,s Research Programme on Substance Use ... aid in smoking reduction therapy. The new drug slows down ... down their smoking. Nicotine is absorbed rapidly through the ... from where it quickly passes through the body and into ...
... Gardner HealthDay Reporter , WEDNESDAY, March 16 (HealthDay ... in a large hospital, more patients died, a new study ... of nursing shortages and cost-cutting, in that the focus should ... the research, appearing in the March 17 issue of the ...
... By Steven Reinberg HealthDay Reporter , ... in the United States reached an all-time low in ... percent from 2008, federal health officials report. , "There ... a statistician at the U.S. Centers for Disease Control ...
... (March 16, 2011) -- On March 28, leading experts ... Congress on Interventional Therapies for Type 2 Diabetes to ... treatment option. The three-day meeting, hosted by NewYork-Presbyterian Hospital/Weill ... together physicians, scientists and policymakers representing 60 countries. The ...
... trial using an all-natural lozenge to treat dry mouth, a ... way at Georgia Health Sciences University College of Dental Medicine. ... closed the faucet, and we want to turn that faucet ... and co-investigator of the study. "The cells and glands that ...
... Young adults are more likely to be heavy drinkers if they ... also had to cope with stressful life events, a new study ... women and 140 men in Germany who were asked about when ... the previous three years, what daily hassles they might have had ...
Cached Medicine News:Health News:New targeted drug helps smokers stub it out 2Health News:When Nurse Staffing Drops, Mortality Rates Rise: Study 2Health News:U.S. Death Rate at All-Time Low: CDC 2Health News:U.S. Death Rate at All-Time Low: CDC 3Health News:Diabetes Surgery 2nd World Congress 2Health News:Diabetes Surgery 2nd World Congress 3Health News:Diabetes Surgery 2nd World Congress 4Health News:Diabetes Surgery 2nd World Congress 5Health News:Clinical trial for dry mouth funded by international oral care award 2Health News:Drinking Behavior May Be Tied to Early Alcohol Use 2
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: