Navigation Links
Phase 3 Data Show NUCYNTA® ER (tapentadol) Extended-Release Tablets Provide Pain Management for Patients with Diabetic Peripheral Neuropathy (DPN)
Date:5/17/2012

last week of the 12-week, double-blind maintenance phase, as determined by an 11-point pain rating scale or numerical rating scale (NRS; 0='no pain,' 10='pain as bad as you can imagine'). Safety assessments were performed on the open-label and double-blind safety populations (all patients who received greater than or equal to 1 dose of open-label and double-blind treatment, respectively). Treatment-emergent adverse events (TEAEs), defined as any AEs (new or worse in intensity) that occurred after the first intake of study drug during the open-label or double-blind phase, were monitored throughout the study.

In the open-label titration period, 459 patients received one or more doses of tapentadol ER and were included in the open-label safety population. At the start of the 3-week, open-label phase, the majority of patients (87.1 percent) reported severe pain (6 or more on the 11-point NRS) with a mean pain intensity of 7.3. By the end of the open-label phase, the mean pain intensity was reduced to 3.6. Treatment-emergent adverse events (TEAEs) experienced by 10 percent or more of patients during the open-label phase were nausea (24.4 percent), dizziness (17), constipation (11.8) and somnolence (10.7).

A total of 358 patients completed the open-label titration period; 318 were randomized and received one or more dose of study medication (n=152 for placebo, 166 for tapentadol ER).

Following randomization, during the double-blind treatment phase to week 12, pain increased in the placebo group (as demonstrated by the mean change in pain intensity of 1.3), while in the tapentadol ER group, efficacy was maintained, as indicated by the mean change in pain intensity of 0.28. The least-squares mean difference between the tapentadol ER and placebo groups in the change in average pain intensity was -0.95 on the 11-point NRS favoring tapentadol ER (95 percent CI, -1.42 to -0.49; p<0.001, tapentadol ER vs. placebo)(4).

For more details about the s
'/>"/>

SOURCE Janssen Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11 12

Related medicine technology :

1. NVA237 Phase III GLOW2 Data at American Thoracic Society (ATS) International Conference and Phase II Clinical Trial Update
2. Boehringer Ingelheim to present pivotal Phase III results for afatinib in first-line treatment of EGFR mutation-positive NSCLC at ASCO 2012
3. Inovio Pharmaceuticals Universal Avian Flu Vaccine Generates Protective Antibody Responses Against Six H5N1 Viruses in Phase I Trial
4. Novelos Therapeutics Successfully Completes First Cohort In Phase 1b Solid Tumor Trial With I-131-CLR1404 (HOT) Cancer-Targeted Molecular Radiotherapeutic
5. Adamas Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA for Arimenda™
6. Pearl Therapeutics Phase 2b Twice-Daily Dosing Data Suggest Morning and Evening Benefit of PT003 in Patients with COPD
7. Results Reported for Phase Ib Open-Label Clinical Trial for the Treatment of Depression Using External Trigeminal Nerve Stimulation (eTNS™) - The USB Port to the Brain™
8. Alder BioPharmaceuticals Inc. Initiates Phase 1 Clinical Study of Antibody Therapeutic Candidate for Treatment of Migraine, ALD403
9. Isis Initiates Phase 2 Study of ISIS-APOCIIIRx in Patients with Hypertriglyceridemia
10. Lexicon Receives Funding for Phase 2 Clinical Trial of LX4211 in Type 1 Diabetes
11. Ultragenyx Announces Phase 1 Results of UX001 in Hereditary Inclusion Body Myopathy (HIBM), a Rare Neuromuscular Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/21/2014)... AUSTIN, Texas , Aug. 21, 2014 /PRNewswire/ ... IT services company, announced today that it has ... Records (EMR) solution for Plastic Surgery and Dermatology ... provide even more value to healthcare practices using ... CEO of eRelevance Corporation. "Using information from the ...
(Date:8/21/2014)... Eisai Limited is pleased to support the Canadian Epilepsy Alliance ... in Canada . The comic book, an ... and their parents about epilepsy, the most common neurological disorder ... Canadians. Eisai is guided by a corporate philosophy known as ... is central – there was a need within the epilepsy ...
(Date:8/21/2014)... CHARLOTTE, N.C. , Aug. 21, 2014 /PRNewswire-iReach/ ... Home Medical Equipment, Inc. for the third straight ... annual Inc. 500|5000, an exclusive ranking of the ... most comprehensive look at the most important segment ... Yelp, Pandora, Timberland, Dell, Domino,s Pizza, LinkedIn, Zillow, ...
Breaking Medicine Technology:eRelevance Corporation Integrates with Nextech Electronic Medical Records 2Eisai Pleased to Support Canadian Epilepsy Alliance Comic Book that Teaches Children About Epilepsy 2Carolina's HME Named for Third Straight Year to Inc. Magazine's List of America's Fastest-Growing Private Companies--the Inc. 5000 2Carolina's HME Named for Third Straight Year to Inc. Magazine's List of America's Fastest-Growing Private Companies--the Inc. 5000 3
... 2011 Susquehanna Growth Equity, LLC (SGE) today announced ... a provider of managed care information for the healthcare ... and interpretation of pharmaceutical and healthcare information from health ... in managed markets. In addition, it offers data collection, ...
... SILVER SPRING, Md., April 18, 2011 ... the U.S. Food and Drug Administration. I nformation in ... times for items are current as of April 18, 2011. ... FDA News & Notes does not contain any regulatory or ...
Cached Medicine Technology:Susquehanna Growth Equity Acquires MediMedia Information Technologies, LLC 2Susquehanna Growth Equity Acquires MediMedia Information Technologies, LLC 3FDA News & Notes - Week of April 18, 2011 2
(Date:8/23/2014)... August 23, 2014 Hundreds of ... on behalf of individuals who were allegedly harmed ... line continue to move forward in the U.S. ... LLP reports. According to an Order dated August ... program that would allow the litigation’s first case ...
(Date:8/23/2014)... August 23, 2014 Professional kitchen employees, ... study aid in preparing for Food Safety Certification exams ... by Dynamic Path. , Dynamic Path announced the ... includes more than 200 review questions for culinary industry ... designed to cover requirements of the ServSafe® Food Safety ...
(Date:8/23/2014)... (PRWEB) August 23, 2014 Teen drug ... Carolina. It’s no different in Wilmington, NC. Substance abuse ... are falling victim to drug and alcohol dependency in ... are looking to overcome substance abuse, but don’t know ... adolescent treatment facility can be a challenge because most ...
(Date:8/22/2014)... August 23, 2014 2014 Deep ... a professional and in-depth research report on the ... Meter information, including Glucose Meter definition, classification, application, ... overview. This research covers the international market analysis, ... analysis covering macroeconomic environment & economic situation analysis. ...
(Date:8/22/2014)... Top 10 Best SEO Hosting ... companies and highly recommended FatCow ( http://www.top10bestseohosting.com/go/FatCow.com/ ) ... of Top 10 Best SEO Hosting states, “It ... hosting supplier. Actually, these companies have outperformed their ... customer support. People can get the best web ...
Breaking Medicine News(10 mins):Health News:Wright Conserve Hip Lawsuits Move Forward, as Federal Court Issues Order Pertaining to Bellwether Trials, Bernstein Liebhard LLP Reports 2Health News:Wright Conserve Hip Lawsuits Move Forward, as Federal Court Issues Order Pertaining to Bellwether Trials, Bernstein Liebhard LLP Reports 3Health News:Wright Conserve Hip Lawsuits Move Forward, as Federal Court Issues Order Pertaining to Bellwether Trials, Bernstein Liebhard LLP Reports 4Health News:Food Handler Safety Certification Made Easy with Dynamic Path 2Health News:Troubled Teens Wilmington Helpline Guides Adolescents to the Path of Recovery 2Health News:Glucose Meter Industry Global (Europe, Asia, NA, ROW) Analysis Now Available at ReportsnReports.com 2Health News:Glucose Meter Industry Global (Europe, Asia, NA, ROW) Analysis Now Available at ReportsnReports.com 3Health News:FatCow Reviews Released by Top10BestSEOHosting.com 2
... ... bring together leaders in open innovation , ... Washington, DC (Vocus) -- This Friday, Prize4Life will be an ... session jointly hosted by the White House Office on Science and Technology Policy, the ...
... ... ... version of Greenpeace’s Cool IT Leaderboard (1) reveals how some global IT companies are leading ... energy use, while others seem unable to decide if IT climate solutions are a significant ...
... also at higher risk for cardiac events, research shows ... with erectile dysfunction, those who also have low testosterone levels ... disease, a new study has found. , In a ... link between obesity and impairment of blood flow to the ...
... an equal opportunity destroyer. It attacks the central nervous ... high-profile victims are celebrated cellist Jacqueline du Pre, whose career ... greatest writers but they are far from alone. ... currently about 400,000 cases in the U.S. and more that ...
... Study finds link between excess weight and the pain disorder, ... News) -- Women who are overweight or obese appear to ... known as fibromyalgia, a new study suggests. , If they ... researcher Paul Mork of Norwegian University of Science and Technology ...
... ... with Invisalign clear aligners, a new technology that may eventually make unattractive, uncomfortable braces ... ever before. , ... Torrance, California (PRWEB) April 29, 2010 -- Torrance orthodontist Dr. Robert Mondavi ...
Cached Medicine News:Health News:Prize4Life Featured in Major Innovation/Prize National Conference 2Health News:Prize4Life Featured in Major Innovation/Prize National Conference 3Health News:IT Leaderboard Showcases Growing Divide Between Talk and Action on Developing Climate Solutions 2Health News:IT Leaderboard Showcases Growing Divide Between Talk and Action on Developing Climate Solutions 3Health News:IT Leaderboard Showcases Growing Divide Between Talk and Action on Developing Climate Solutions 4Health News:Low Testosterone Raises Heart Death Rates in Impotent Men 2Health News:Catching multiple sclerosis before it strikes 2Health News:Catching multiple sclerosis before it strikes 3Health News:Exercise, Weight Control May Keep Fibromyalgia at Bay 2Health News:Invisalign Clear Aligners Available at Blue Sky Family Dental by Torrance Dentist, Dr. Robert Mondavi 2Health News:Invisalign Clear Aligners Available at Blue Sky Family Dental by Torrance Dentist, Dr. Robert Mondavi 3
... 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 ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: