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:7/10/2014)... July 10, 2014  Breg, Inc., a premier ... launched the FreeRunner™ knee brace with new innovations ... patella mal-tracking return to active lifestyles.  FreeRunner,s patent-pending ... braces, providing support when patients need it most, ... don,t. Patellofemoral issues are the most ...
(Date:7/10/2014)...  Valeant Pharmaceuticals International, Inc. (NYSE: VRX ... the sale to Galderma of all rights to Restylane, ... Valeant for $1.4 billion in cash, pursuant to the ... its acquisition of Galderma. "We are ... a company that is firmly committed to the aesthetic ...
(Date:7/10/2014)... , July 10, 2014 Decision Resources ... awareness of the U.S. Food and Drug Administration,s (FDA) ... phosphate binder Velphoro, which was approved by the FDA ... chronic kidney disease (CKD) patients on dialysis. ... TreatmentTrends: Nephrology (US) Q2 2014 : ...
Breaking Medicine Technology:Breg Introduces Knee Brace to Help Runners with Patellofemoral Pain Syndrome 2Half of Surveyed Nephrologists Report Moderate Familiarity with Velphoro, Which Received FDA Approval Late Last Year for the Treatment of Hyperphosphatemia in Dialysis 2Half of Surveyed Nephrologists Report Moderate Familiarity with Velphoro, Which Received FDA Approval Late Last Year for the Treatment of Hyperphosphatemia in Dialysis 3
... LAGUNA HILLS, Calif., Oct. 6 Minnow Medical, Inc., ... thermoplasty for the treatment of in-stent restenosis and other ... veteran medical device executives. Prabodh Mathur ... K. Handley has been named vice president of quality, ...
... Oct. 6 Ferring Pharmaceuticals Inc. today announced ... trials of LYSTEDA™ (tranexamic acid) tablets for cyclic ... of the peer-reviewed journal, Obstetrics & Gynecology ... significantly reduced menstrual blood loss from baseline, and ...
Cached Medicine Technology:Minnow Medical Bolsters Management Team 2Minnow Medical Bolsters Management Team 3Obstetrics and Gynecology Publishes Data From Pivotal Phase 3 LYSTEDA Study 2Obstetrics and Gynecology Publishes Data From Pivotal Phase 3 LYSTEDA Study 3Obstetrics and Gynecology Publishes Data From Pivotal Phase 3 LYSTEDA Study 4
(Date:7/11/2014)... GA (PRWEB) July 11, 2014 Datalogic ... step in improving sanitation hospital wide. With their new ... the spread of disease, like the devastating MRSA, which ... The Gryphon GD4400-HC 2D and the Gryphon ... 2D barcodes and can even read barcodes off of ...
(Date:7/11/2014)... -- U.S. health officials have concluded that it,s highly ... during a safety mishap last month. But, the ... announced a moratorium on the transfer of any dangerous ... a report issued Friday, the CDC outlined several measures ... incident doesn,t occur again. Last month, as many as ...
(Date:7/11/2014)... enterprises today are shifting towards the changing trend in ... offer these global enterprises a strategic method to cut ... operational costs to companies. The aim to minimize operational ... market driver for expanding the managed services market in ... estimated to grow from $142.75 billion in 2013 to ...
(Date:7/11/2014)... 10, 2014) Obese and overweight firefighters are ... care providers, according to new research from The ... (UTHealth). , National guidelines state that health care ... of maintaining a healthy weight. Firefighters have high ... leading cause of line-of-duty deaths in firefighters. This ...
(Date:7/11/2014)... 11, 2014 (HealthDay News) -- Prostate cancer patients are ... less effective treatment and die sooner if they also ... data from more than 41,200 American men who were ... They followed them through 2009. Nearly 1,900 of the ... years before their prostate cancer was discovered. "Men ...
Breaking Medicine News(10 mins):Health News:Stop Spreading Disease with the New Disinfectant-Ready Bar Code Scanner 2Health News:Stop Spreading Disease with the New Disinfectant-Ready Bar Code Scanner 3Health News:CDC Issues Tough Report on Anthrax Scare 2Health News:North America Managed Services Market Worth $68.65 Billion by 2018 - New Report by MicroMarket Monitor 2Health News:North America Managed Services Market Worth $68.65 Billion by 2018 - New Report by MicroMarket Monitor 3Health News:North America Managed Services Market Worth $68.65 Billion by 2018 - New Report by MicroMarket Monitor 4Health News:Depression May Make It Harder to Beat Prostate Cancer 2
... Germany and America who had treated injured protestors while ... to // leave Nepal by the King Gyanendra's government. ... detained Wednesday after he appeared on a private television ... brutally assaulted by the security forces. ,On ...
... at the McDonald’s or KFC restaurants, across the world, have ... levels of the same // food elsewhere. ,According to ... of Medicine, the researchers analysed various food items like McDonald's ... in many countries between 2004 and 2005, the Associated Press ...
... that been launched on a trial basis in Singapore would ... intensive care unit//. A camera hooked up beside the baby's ... to view the live footage on 3G-enabled mobile phones, Singapore ... on a three-month trial, during which the infants go online ...
... symposium titled ‘Challenging Intellectual Property’ will be analyzed and ... ,The Symposium will look into the aspects of ... production in economic development. It will also gauge the ... table, desirous of bringing a change in health research ...
... way to reverse the process of cell division. This ... could be an important milestone in the fight// against ... from the Oklahoma Medical Research Foundation have published their ... a million times in the human body each day. ...
... If you thought that McDonalds’ in USA serves the same ... and// think!,According to a study by three Danish doctors, fat ... as "trans fat" in foods purchased at McDonald's Corp and ... to the staggering research published in this week's New England ...
Cached Medicine News:
Helmer's Horizon Series line of refrigerators are designed specifically for the cost conscious buyer. This line offers outstanding performance, quality, and the features you need to ensure the safety...
... presents i.Series refrigerators ... solutions for the blood ... features than ever before, ... are at the forefront ...
This storage freezer, which is based on our premium freezer line, maintain red cells safely below regulatory standards at -86C (-123F). Recorder is standard for model 8627. Model 8627 is UL Listed, C...
The TBR-360-1-GD is a large capacity upright style operating temperature +4C. It is specially designed refrigerators for the storage of blood in standard 500ml bags, complying with Australian Standar...
Medicine Products: