Navigation Links
Pivotal Phase 3 Study Compares Tapentadol Extended Release Tablets to Placebo in Patients with Chronic Osteoarthritis Knee Pain
Date:8/30/2010

RARITAN, N.J., Aug. 30 /PRNewswire/ -- Phase 3 safety and efficacy data comparing tapentadol extended release (ER) tablets, an investigational pain medication, to placebo in patients with moderate to severe chronic osteoarthritis knee pain have been published by Clinical Drug Investigation. In addition, this study compared oxycodone controlled release (CR) to placebo as an active control.  

Tapentadol ER vs. Placebo

The study demonstrated that a significantly higher percentage of patients receiving tapentadol ER tablets achieved at least a 50 percent improvement in average pain intensity compared to placebo (32 percent vs. 24.3 percent, respectively; nominal p = 0.027), indicating a clinically significant improvement in pain intensity.

To measure perceived change in overall health status, patients also were asked to report their pain at Weeks 5 and 9 of the maintenance period and at the end of treatment. Results of this patient global impression of change (PGIC) analysis indicated that patients receiving tapentadol ER tablets showed statistically significant improvements compared with placebo (nominal p<0.001).

Primary endpoints for the study were the changes in average daily pain intensity from baseline (11-point numerical rating scale) over the last week of maintenance and over the study's entire 12-week maintenance period. Tapentadol ER significantly reduced average pain intensity from baseline to Week 12 of the maintenance period versus placebo (least squares mean [LSM] difference [95 percent confidence interval], -0.7 [-1.04, -0.33]), and throughout the maintenance period (-0.7 [-1.00, -0.33]).

The incidence of patients who reported at least one treatment-emergent adverse event (TEAE) was 61.1 percent for placebo and 75.9 percent for tapentadol ER. The percentages of tapentadol ER patients experiencing common TEAEs (reported by ≥10 percent in any group of the study) included
'/>"/>

SOURCE PriCara(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9

Related medicine technology :

1. Lost and Found: L2FU Recovers 100% of Clinical Trial Patients for Recent Pivotal Study
2. Kiadis Pharma Receives IND Approval From FDA to Start Pivotal Clinical Trial With ATIR(TM) in the United States
3. Crux Biomedical Enrolls First Patient in Its Retrieve 2 U.S. Pivotal Trial
4. Boehringer Ingelheim Announces Pivotal Phase III Data Showing Linagliptin Reduced Blood Sugar Compared to Placebo in People With Type 2 Diabetes
5. Pivotal Phase III Trial of Novartis Drug Afinitor® Met Primary Endpoint in Study of Patients With Advanced Pancreatic Neuroendocrine Tumors
6. Pivotal Data for the Investigational Treatment PSD502 for Primary Premature Ejaculation in the United States to be Presented at Major Medical Meeting
7. QRxPharma Releases Additional Pivotal Phase 3 Combination Rule Study Data for MoxDuo(R)IR in Patients with Post-Surgical Pain
8. Agendia to Play Pivotal Role in ISPY-2 Trial for Breast Cancer
9. Zogenix Initiates Pivotal Phase 3 Clinical Trial for Novel Formulation of Oral Controlled-Release Hydrocodone
10. NovaShunt Starts its Pivotal Clinical Study "PIONEER" to Demonstrate the Clinical Value of the AFS System
11. QRxPharma Initiates Second Pivotal Phase 3 Study of MoxDuo(TM)IR Dual-Opioid(TM) for NDA Submission
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/21/2014)... Aug. 21, 2014  Armada Health Care (Armada), ... (GPO), is pleased to announce an agreement with ... host of innovative specialty pharmacy patient program offerings. ... therapy management services to specialty patients via Armada,s ... Aurora will use the OTM platform as ...
(Date:8/21/2014)... /CNW/ - Bedrocan Cannabis Corp., previously Bedrocan Canada Inc. ... Board of Directors, enhancing executive oversight and strengthening ... leading licensed producer of medicinal cannabis in ... years, experience in producing and supplying government-regulated pharmaceutical-grade ... As previously announced in a ...
(Date:8/21/2014)... Pa. , Aug. 21, 2014   ... ), a specialty biopharmaceutical company, today announced positive ... of collagenase clostridium histolyticum (or CCH) for the ... as cellulite. In the Phase 2a trial, all ... and high (0.84mg)) showed an improvement in the ...
Breaking Medicine Technology:Aurora Health Care Partners with Armada Health Care to Deliver Added Pharmacy Capabilities to Specialty Patients 2Aurora Health Care Partners with Armada Health Care to Deliver Added Pharmacy Capabilities to Specialty Patients 3Senior Life Sciences Executives Join Bedrocan as Independent Directors 2Senior Life Sciences Executives Join Bedrocan as Independent Directors 3Auxilium Pharmaceuticals, Inc. Announces Positive Data From Phase 2a Study Of CCH In Patients With Cellulite 2Auxilium Pharmaceuticals, Inc. Announces Positive Data From Phase 2a Study Of CCH In Patients With Cellulite 3Auxilium Pharmaceuticals, Inc. Announces Positive Data From Phase 2a Study Of CCH In Patients With Cellulite 4Auxilium Pharmaceuticals, Inc. Announces Positive Data From Phase 2a Study Of CCH In Patients With Cellulite 5Auxilium Pharmaceuticals, Inc. Announces Positive Data From Phase 2a Study Of CCH In Patients With Cellulite 6Auxilium Pharmaceuticals, Inc. Announces Positive Data From Phase 2a Study Of CCH In Patients With Cellulite 7
... (Nasdaq: DNDN ) today announced that the ... convertible senior notes due January 15, 2016 (the "Notes") ... to purchase an additional $80 million aggregate principal amount ... exercise of the overallotment option, resulted in net proceeds ...
... Hospira, Inc. (NYSE: HSP ), the ... Food and Drug Administration (FDA) approval of Topotecan Injection, ... in the United States. The medication is a generic ... more than $140 million. Hospira,s topotecan is indicated for ...
Cached Medicine Technology:Dendreon Announces Exercise and Closing of Overallotment Option 2Hospira Announces FDA Approval of Topotecan Injection 2
(Date:8/21/2014)... diabetic peripheral neuropathy is important for the successful ... Fourth Affiliated Hospital of Kunming Medical University, China, ... a sensitive index for nerve conduction studies in ... patients with diabetes mellitus. Nerve conduction studies revealed ... conduction velocity was slower, and sensory nerve action ...
(Date:8/21/2014)... Bedros Keuilian’s Annual Fitness Business Summit is ... by many people already earning seven-figure incomes. But his annual ... only open to the owners of Keuilian’s own international fitness ... Fit Body Boot Camp World Conference will also be attended ... boot camp or are struggling with their own boot ...
(Date:8/21/2014)... (PRWEB) August 21, 2014 Quantum ... are pleased to announce the healthcare technology platform, ... operational/production servers. , The company anticipates provisioning its ... are established between individual physicians, via interfaces, to medical ... and finally with electronic data exchanges and medical clearing ...
(Date:8/21/2014)... August 21, 2014 Australian scientists say ... Staph bacteria has been used to successfully fight mesothelioma ... article on the new research. Click here to ... of Western Australia treated mesothelioma cells with ... the cancer cells while simultaneously stimulating a stronger anti-tumor ...
(Date:8/21/2014)... B. E. Smith, the only full-service leadership solutions ... to lead a national Chief Nurse Executive ... in Valdosta, GA. The top executive search firm ... recently placed more than 900 healthcare executives into organizations. ... organization headquartered in Valdosta, GA., and its four campuses ...
Breaking Medicine News(10 mins):Health News:Fitness Boot Camp Founder Offers Fifty Scholarships to Fit Body Boot Camp World Conference 2Health News:Fitness Boot Camp Founder Offers Fifty Scholarships to Fit Body Boot Camp World Conference 3Health News:Grace Century’s Electronic Health Records Project, Quantum Innovations, Announces That PWeR® Healthcare Technology Platform is Ready for Deployment 2Health News:Grace Century’s Electronic Health Records Project, Quantum Innovations, Announces That PWeR® Healthcare Technology Platform is Ready for Deployment 3Health News:Grace Century’s Electronic Health Records Project, Quantum Innovations, Announces That PWeR® Healthcare Technology Platform is Ready for Deployment 4Health News:Study Finds Bacteria Compound Shrinks Mesothelioma Tumors, According to Surviving Mesothelioma 2Health News:South Georgia Medical Center Retains B. E. Smith to Recruit New Chief Nurse Executive 2Health News:South Georgia Medical Center Retains B. E. Smith to Recruit New Chief Nurse Executive 3
... trials in humans to treat obesity from a drug derived ... the Managing Director of the company. ,As per ... and each part of the plant has a different effect ... has the power to curb hunger, some other part of ...
... who wear a special kind of no-line bifocal lenses ... who wear more conventional lenses according to a new// ... Ophthalmology & Visual Science (IOVS). ,The ... myopia progression was slower in children wearing progressive-addition lenses ...
... February is National Children's Dental Health Month and as ... its Fifth Annual Give Kids A Smile Day on ... the ADA offers advice for parents and caregivers to ... ,"Preventive dental care has greatly improved the oral health ...
... pill-sized robot that can travel inside your body, can find ... to a computer//. ,After being swallowed, the robot ... Daily Mail. The miniature video camera fitted with the device ... ,The extraordinary invention by Alex Zivanovic of Imperial College, London, ...
... be bustling around hospital wards in as little as ... developed ground-breaking software//. ,The mechanised "nursebots" being ... such as mopping up spillages, taking messages and guiding ... distribute medicines and even monitor the temperature of patients ...
... if its treatment guidelines are followed, the death rate in ... 5%, but it is more common for 20% or over ... the deaths of 1.5 million children every year. ... Professor of Paediatrics in Blantyre, Malawi discusses whether the problem ...
Cached Medicine News:Health News:Good Oral Health Practices Should Begin in Infancy 2Health News:Robot Nurses Ready For Hospitals 'In Three Years' 2
Our soft guedel airway is clear and has a color coded bite block. Airway has a smooth finish and is Latex Free. Recommended for single use. Non-Sterile....
New - Color Coded Berman Airways. A simple idea makes size identification easier for you., ,Premium upgrade without a premium price. Color Coded Berman airways are latex-free., ,Plastic. Single use...
... Endotracheal Tube Kits (silicone) Magill, ... includes a SidePort™ AutoControl™ airway connector, ... mm ISO connector., ,The wire ... helping to ensure an open airway., ...
... Portex® Blue Line® uncuffed ... Magill or Murphy styles, in ... ,Blue Line® adult and pediatric ... from implant-tested polyvinyl chloride with ...
Medicine Products: