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

patients with DPN."

The findings of this study are consistent with those of another Janssen-sponsored study published early last year, which found tapentadol ER to be effective versus placebo for relieving moderate to severe chronic pain associated with diabetic peripheral neuropathy.

"We are pleased the Phase 3 data presented today showed tapentadol ER was effective at providing pain management for patients with chronic, moderate to severe pain associated with DPN," said Christine Rauschkolb, M.D., Ph.D., Vice President and Head of Integrated Operations, Janssen Research & Development, LLC and one of the study's authors. "Janssen has a long history of helping physicians provide responsible treatment for patients to relieve their acute and chronic pain. We are committed to developing new pain management options for the millions of Americans who have painful DPN."

About the Study

This Phase 3 clinical trial was a randomized-withdrawal, placebo-controlled study.  It enrolled adult patients who had moderate to severe, chronic painful DPN for six months or more and a history of analgesic use for painful DPN for three months or more. This trial had three phases: an open-label phase, which included a 3-week titration period during which the individually optimized tapentadol ER dose (100-250 mg two times per day) was determined for each patient; a 12-week, double-blind maintenance phase, during which patients with a one-point or greater reduction in pain intensity from beginning to end of titration were randomized either to continue taking tapentadol ER (at their optimal dose) or to receive placebo; and a follow-up period with a clinic visit at four days and a telephone interview at 10 to 14 days after discontinuation of study drug.

The primary efficacy endpoint of the study was the mean change in average pain intensity from baseline (point of randomization) to the
'/>"/>

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

0

GOOD

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:5/21/2013)... 2013   RxAlly , a first-of-its-kind alliance ... the publication of a white paper entitled Personalized ... The white paper highlights an unprecedented solution for ... engagement to avert strains on the health care ... a range of individually-tailored, pharmacist-provided clinical and consultative ...
(Date:5/20/2013)... -- Volcano Corporation (NASDAQ: VOLC ) a leading ... to enhance the diagnosis and treatment of coronary and ... efforts to expand research and innovation surrounding its physiology ... ® (Instant Wave-Free Ratio™) 1 technologies, via ... 2013 in Paris . ...
(Date:5/20/2013)... Landauer, Inc. (NYSE: LDR ), ... and monitoring, outsourced medical physics services and high quality ... Directors declared, at its meeting on May 16, 2013, ... for the third quarter of fiscal 2013.  The dividend ... of record on June 7, 2013. About ...
Breaking Medicine Technology:RxAlly Releases White Paper on Necessity of Personalized Pharmacist Care 2RxAlly Releases White Paper on Necessity of Personalized Pharmacist Care 3Volcano to Highlight its Physiology Expansion Efforts at EuroPCR 2013 2Volcano to Highlight its Physiology Expansion Efforts at EuroPCR 2013 3Volcano to Highlight its Physiology Expansion Efforts at EuroPCR 2013 4Landauer, Inc. Declares Regular Cash Dividend 2
(Date:5/21/2013)... Beginning May 21st, 2013, DTP Sales ... 8000, the newest in digital recording technology, to the ... product for anyone looking to get the most from ... 8000 is expected to have revolutionary options and ... voice recorder features and highlights: , ...
(Date:5/21/2013)... (PRWEB) May 21, 2013 Tools4ever, the ... has made its Self Service Reset Password Management (SSRPM) ... employees can now use the service on mobile systems ... end users can easily reset their Windows passwords anywhere, ... of questions correctly, the user may then reset his ...
(Date:5/21/2013)... HealthDay Reporter , , MONDAY, May 20 ... millions of people with chronic obstructive pulmonary disease ... among older patients, a new large Canadian study ... age 65 who are prescribed long-acting bronchodilators -- ... as Serevent). Both medications are commonly used to ...
(Date:5/21/2013)... PHILADELPHIA The surgical management of non-small cell lung ... the race of the patient, according to a new ... I and Stage II NSCLC is surgery," said researcher ... in Omaha, Nebraska. "In our study of more than ... the years 2000 and 2010, we found statistically significant ...
(Date:5/21/2013)... 2013, PHILADELPHIA ─ A novel approach to obstructing ... of asthma has shown promise in a Phase ... , Their research will be presented at the ... simultaneously online in the New England Journal ... trial tested the efficacy and safety of the ...
Breaking Medicine News(10 mins):Health News:DTP Sales & Service Announces Upcoming Availability Of Philips Pocket Memo 8000 Series 2Health News:Tools4ever’s password reset software ready for BYOD 2Health News:Certain COPD Meds Might Raise Heart Risks, Study Says 2Health News:Certain COPD Meds Might Raise Heart Risks, Study Says 3Health News:Monoclonal antibody appears effective and safe in asthma Phase IIa trial 2Health News:Monoclonal antibody appears effective and safe in asthma Phase IIa trial 3
... of the Board, SAN DIEGO, Aug. 30 ... board of directors has unanimously approved a,succession plan for ... T. Gallahue will be promoted to Chief Executive Officer ... will succeed Dr. Peter,C. Farrell, 65. As of January ...
... following is a,memorandum to editorial writers and columnists:, ... Communications,Director, SUBJECT: Katrina Storm Warning, On ... New Orleans,and the Gulf Coast are struggling to ... disasters in U.S. history. Disaster often strikes suddenly,and ...
... air pollution, aging are main causes of spread worldwide, ... There are more people around the world suffering from ... international team of researchers reports. , Worse yet, those ... continues to age, claims the study in the Sept. ...
... Aug. 30 Omnicell, Inc.,(Nasdaq: OMCL ) a ... and operational efficiency in healthcare,facilities, today announced that Randall ... president & CFO will present at the Thomas Weisel,Partners ... Mass.,on Wednesday, September 5, 2007 at 11:30 a.m. Eastern ...
... Aug. 30 The following was issued,today by Active ... Executive Director, Active Minds, Inc. WHAT: Ms. Malmon ... student advocacy, including depression and suicide Ms. Malmon ... is,nationally recognized for her unique peer-to-peer approach in addressing,the ...
... N.C., Aug. 30 Cogdell Spencer Inc.,(NYSE: ... acquired Summit,Professional Plaza I and II in Brunswick, ... building complex totals 97,472 square feet and is,98 ... new market and new client relationship,for Cogdell Spencer. ...
Cached Medicine News:Health News:ResMed Names Kieran Gallahue as Chief Executive Officer, Effective January 1, 2008. 2Health News:Campaign for America's Future Memorandum: Katrina Storm Warning 2Health News:Campaign for America's Future Memorandum: Katrina Storm Warning 3Health News:Campaign for America's Future Memorandum: Katrina Storm Warning 4Health News:Campaign for America's Future Memorandum: Katrina Storm Warning 5Health News:Prevalence of COPD Greater Than Thought 2Health News:Prevalence of COPD Greater Than Thought 3Health News:Omnicell to Present at Thomas Weisel Healthcare Conference 2007 2Health News:College Mental Health Expert and Sister of Student Who Died By Suicide Available to Discuss College Mental Health Issues 2Health News:Cogdell Spencer Inc. Acquires Summit Professional Plaza I and II in Brunswick, Georgia 2
... 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 ...
... 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 ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: