Navigation Links
Cadence Pharmaceuticals Updates Omigard(TM) Clinical Timeline
Date:9/15/2008

SAN DIEGO, Sept. 15 /PRNewswire-FirstCall/ -- Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) announced today that it has revised the expected timing of its announcement of results for the CLIRS trial, the company's Phase III clinical trial of Omigard(TM) (omiganan pentahydrochloride 1% topical gel) for the prevention of catheter-related infections.

Cadence is currently engaged in discussions with the U.S. Food and Drug Administration (FDA) regarding the statistical analysis plan for the CLIRS trial. These discussions, which are being conducted under a Special Protocol Assessment (SPA), must be completed prior to unblinding the data from the trial. As a result, Cadence has revised the expected timing of its announcement of results for the CLIRS trial from the fourth quarter of 2008 to the first quarter of 2009. If the trial is successful, Cadence continues to plan for submission of a New Drug Application (NDA) for Omigard in the second quarter of 2009.

About the CLIRS trial

The CLIRS trial, or Central Line Infection Reduction Study, is Cadence's confirmatory Phase III clinical trial of Omigard(TM) for the prevention of catheter-related infections. The CLIRS trial is a multi-center, randomized, evaluation committee-blinded study in patients whose medical condition requires a central venous catheter. The primary efficacy endpoint of the clinical trial is to evaluate whether Omigard is superior to 10% povidone-iodine in the prevention of local catheter-site infections. The CLIRS trial, which has completed enrollment of over 1,850 patients randomized to receive either Omigard or 10% povidone-iodine, is designed to have 80% power to detect significance at the 0.05 level. The CLIRS trial is being conducted under an SPA with th
'/>"/>

SOURCE Cadence Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Cadence Pharmaceuticals to Host Conference Call and Webcast to Discuss Second Quarter 2008 Financial Results and Provide a Clinical Program Update on August 7, 2008
2. Cadence Pharmaceuticals Reports First Quarter 2008 Financial Results and Provides Clinical Program Update
3. Cadence Pharmaceuticals Completes Enrollment of Pivotal Phase III Trial for Intravenous Acetaminophen Ahead of Schedule
4. VIA Pharmaceuticals to Present at American Heart Association Scientific Sessions 2008
5. Unibioscreen and Drais Pharmaceuticals Partner to Develop and Commercialize UNBS 5162 for Treatment of Cancer
6. Vanda Pharmaceuticals Provides Update on Iloperidone
7. Cerimon Pharmaceuticals Announces Positive Results from a Phase II Clinical Study of Its Diclofenac Sodium Patch for Acute Pain
8. Jazz Pharmaceuticals, Inc. Announces Final Patient Has Completed Phase III Clinical Trial of Sodium Oxybate to Treat Fibromyalgia
9. Addrenex Pharmaceuticals Announces Positive Phase III Clinical Results for Clonicel to Treat ADHD
10. Celator Pharmaceuticals Receives Orphan Drug Designation for Anticancer Agent CPX-351
11. Idenix Pharmaceuticals Announces Completion of Proof-of-Concept Study for IDX899 in Treatment-Naive HIV-Infected Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/31/2015)... 31, 2015 Pepperl+Fuchs, a world leader ... Corporation, a leading provider of HART protocol devices. ... further extend its integrated solutions offerings and strengthen ... "We are pleased to add the MACTek ... Jim Bolin , Pepperl+Fuchs, executive vice president ...
(Date:8/31/2015)... , Aug. 31, 2015  Ascendant Solutions, Inc. ... today announced that its Healthcare subsidiary, Dougherty,s Holdings, has ... on the downtown square of Springtown, Texas ... than 35 years, this community-based pharmacy has provided retail ... of Springtown . The ...
(Date:8/31/2015)... 2015  Daktari Diagnostics today announced a collaboration with Merck, ... and Canada , to develop Daktari,s ... up to $8.5 million over the next 3.5 years, will ... regulatory approval of Daktari,s HCV test. The ... can detect low levels of virus directly in a single ...
Breaking Medicine Technology:Ascendant Solutions, Inc. Announces Completion of Fifth Pharmacy Acquisition by Its Dougherty's Holdings Subsidiary 2Ascendant Solutions, Inc. Announces Completion of Fifth Pharmacy Acquisition by Its Dougherty's Holdings Subsidiary 3Daktari Enters Collaboration Agreement with Merck to Develop Test for Hepatitis C Virus 2Daktari Enters Collaboration Agreement with Merck to Develop Test for Hepatitis C Virus 3
... grounds, direct programming is superior,to cloning as a ... Nov. 20 Two major scientific,papers published this ... way to,generate patient-matched human pluripotent stem cells without ... or human or animal eggs.,Research groups in Wisconsin ...
... 20 The following statement,was released today by ... the Elizabeth Glaser Pediatric AIDS Foundation:, "Four ... Relief,(PEPFAR) began funding treatment and prevention, today,s report ... remains a devastating worldwide,pandemic, we are beginning to ...
Cached Medicine Technology:Two Major Studies Show: Human Pluripotent Stem Cells without Cloning or Destroying Embryo 2Two Major Studies Show: Human Pluripotent Stem Cells without Cloning or Destroying Embryo 3New UNAIDS Report Offers Encouraging News, But Most HIV-Positive Mothers Still Not Getting the Care & Treatment They Need 2
(Date:8/31/2015)... ... August 31, 2015 , ... The 2015 ... to patients and family members, medical professionals, and researchers, covering a variety of ... conference is a collaborative effort between the Mesothelioma Applied Research Foundation ...
(Date:8/31/2015)... CA (PRWEB) , ... August 31, 2015 , ... Patients ... from and those who are interested in learning more about the procedure beyond the ... Mohebi. , Internationally recognized hair transplant surgeon Parsa Mohebi will be on hand ...
(Date:8/31/2015)... , ... August 31, 2015 , ... The Sundance Film ... on Tuesday, September 1. , “Alive Inside” shadows a social worker who advocates for ... , “It’s a documentary about bringing music to residents in health care centers who ...
(Date:8/31/2015)... Scotch Plains, NJ (PRWEB) , ... August 31, ... ... in practice! Garden State Urology was formed in 2008, the result of a ... on the principle that by working cooperatively, they could provide more cost-effective and ...
(Date:8/31/2015)... ... ... Docs Presents, Dr. Michael Betsy! Dr. Betsy has been reviewed and approved as an ... from Don Bosco Prep in 1990 and was Class Salutatorian. He earned Varsity letters ... senior year. He was inducted into the National Honor Society as a sophomore, was ...
Breaking Medicine News(10 mins):Health News:New York Experts on Mesothelioma Come Together at Memorial Sloan Kettering Cancer Center 2Health News:New York Experts on Mesothelioma Come Together at Memorial Sloan Kettering Cancer Center 3Health News:Watch a Live Hair Transplant at Parsa Mohebi Hair Restoration’s Open House 2Health News:Public Invited to Dementia Documentary Screening at North Carolina Retirement Community 2Health News:NJ Top Docs Presents, Garden State Urology! 2Health News:NJ Top Docs Presents, Dr. Michael Betsy! 2Health News:NJ Top Docs Presents, Dr. Michael Betsy! 3
... processing, benefit administration, and care management solution for ... 3 HealthEdge, provider of the only modern, ... that Rob Gillette, in addition to continuing as ... of Ohio-based Click4Care, a leading provider of next-generation ...
... June 3 Quest Diagnostics Incorporated (NYSE: DGX ... services, announced today that, as of 5:00 p.m., New York ... the following principal amounts of its 5.125% Senior Notes due ... have been validly tendered and not validly withdrawn in connection ...
... today that five prestigious cord blood transplantations centers in ... joined the ExCell study. Participating clinical ... Clnic of Barcelona, Barcelona: Principal Investigator, Dr. Enric Carreras, ... Dr. Cristina Arbona, MD , Hospital de ...
... Ill. --- Men and women may not be from two ... mate selection, according to new research from Northwestern University. ... approaching potential romantic partners, they were not any pickier than ... the speed dating study. That finding, ...
... to gestational weight gain guidelines , TUESDAY, June 2 ... changes in pregnancy weight gain recommendations, obese women who ... outcomes than obese women who gained more. , Just ... and the National Research Council updated their gestational weight ...
... to animals on factory farms , , WASHINGTON, June 3 ... campaign is posing to area commuters and people visiting Capitol Hill. ... stations and trains this week by the Pew Campaign on Human ... of the project,s national effort to end the misuse of antibiotics ...
Cached Medicine News:Health News:HealthEdge(R) and Click4Care(R) Announce Common Leadership 2Health News:Quest Diagnostics Announces Early Tender Results of Offer to Purchase Up to $200 Million Aggregate Principal Amount of Certain of its Outstanding Notes 2Health News:Quest Diagnostics Announces Early Tender Results of Offer to Purchase Up to $200 Million Aggregate Principal Amount of Certain of its Outstanding Notes 3Health News:5 Spanish centers join a study for a new leukemia and lymphoma treatment technique 2Health News:Women may not be so picky after all about choosing a mate 2Health News:Women may not be so picky after all about choosing a mate 3Health News:Fewer New Pounds in Pregnancy Best for Obese Moms 2Health News:Fewer New Pounds in Pregnancy Best for Obese Moms 3Health News:New Ad Campaign Asks D.C. Commuters 'Who's Hogging Our Antibiotics?' 2
Bunnel hand drill with Jacobs chuck, chuck size 4 mm....
Children's hospital hand drill, hexagonal handle, twist drill diameter 4.2 mm....
Hudson Drill hand drill....
Hudson Downs hand drill....
Medicine Products: