Navigation Links
Horizon Therapeutics Announces Two Pivotal HZT-501 Phase 3 Trials Meet Primary Endpoints
Date:12/2/2008

riod, as compared to ibuprofen, in patients at risk for NSAID-induced ulcers. The primary objective of REDUCE-2 was to evaluate HZT-501 in reducing the proportion of patients who develop endoscopically diagnosed gastric and/or duodenal ulcers during the 24-week treatment period, as compared to ibuprofen, in patients at risk for NSAID-induced ulcers. The trials were conducted via a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA).

Patients, who had mild-to-moderate pain, including those with osteoarthritis, were randomly assigned, in approximately a 2:1 ratio, to receive HZT-501 (800 mg ibuprofen and 26.6 mg famotidine) or ibuprofen (800 mg) alone orally three times daily for a 24- week treatment period or until patients developed either an endoscopically diagnosed upper gastrointestinal ulcer and/or prohibitive toxicity. Patients received endoscopies at baseline and weeks 8, 16 and 24. 8025 Lamon Avenue, Suite 110, Skokie, IL 60077

In REDUCE-1, 24-week treatment with HZT-501 resulted in a statistically significant reduction in gastric ulcers versus treatment with ibuprofen alone. In REDUCE-2, 24-week treatment with HZT-501 resulted in a statistically significant reduction in gastric and/or duodenal ulcers versus treatment with ibuprofen alone.

Treatment with both HZT-501 and ibuprofen alone were well tolerated in the studies. The majority were mild to moderate in severity. There were no significant differences between the two treatment groups adverse event or serious adverse event profiles.

"NSAIDs can cause significant gastrointestinal damage, including ulcers of the stomach and duodenum," said Loren Laine, MD, professor of medicine, Division of Gastrointestinal and Liver Diseases, Keck School of Medicine, University of Southern California. "These results indicate that HZT-501 can reduce the risk of ulcers, potentially improving the GI safety
'/>"/>

SOURCE Horizon Therapeutics, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. HORIZONS AMI Trial Demonstrates Superior Outcomes with TAXUS(R) Drug-Eluting Stents in Heart Attack Patients
2. Horizon Therapeutics Completes Enrollment in Phase 3 Trials for Lead Product Candidate HZT-501
3. GlaxoSmithKline and Theravance Announce Start of Large Phase 2B ICS and LABA Studies for Asthma in the Horizon Program
4. Horizon Therapeutics Initiates Long-Term Phase 3 Safety Study for Lead Product Candidate HZT-501
5. Duska Therapeutics Applies for Phase 3 Special Protocol Assessment
6. Alba Therapeutics Announces Enrollment of Its First European Patient in Global Phase IIb Study of Larazotide Acetate for Treatment of Active Celiac Disease
7. Cell Therapeutics Pixantrone Phase III (EXTEND) Pivotal Trial Successful in Achieving Primary Endpoint
8. Cell Therapeutics Announces Study Data Set Cut-off for Phase III Pivotal Pixantrone (301) Trial
9. InteRNA Technologies and VU University Medical Center to Develop microRNA-Based Diagnostics and Therapeutics for Cancer
10. Sirion Therapeutics Announces Positive Pivotal Uveitis Data for Durezol(TM)
11. XTENT Announces Clinical Trial Data to be Presented at Annual Meeting of Transcatheter Cardiovascular Therapeutics Next Week
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... 2014  Novastem, a leader in regenerative medicine, ... its study for ischemic stroke at Clinica Santa ... strokes account for 87 percent of all stroke ... the study, entitled "Internal Research Protocol in Combination ... Cells and Intrathecal Administration of Neural Stem Cells ...
(Date:12/24/2014)... Pa. , Dec. 24, 2014  Commonwealth Cornerstone Group ... Markets Tax Credits transaction on Tuesday to help fund the ... Network (PHN) in Sharon . ... in Pennsylvania . It is the largest ... with more than 150 people on staff. Currently, ...
(Date:12/24/2014)... N.Y. , Dec. 24, 2014 Kinex ... dosed with KX2-361 at Roswell Park Cancer Institute. ... small molecule drug that has shown potent inhibitory activity ... including those that are resistant to Temozolomide (T98G), the ... glioma. In a well-established brain tumor mouse model, KX2-361 ...
Breaking Medicine Technology:Novastem Treats First Patient Using Stemedica's Mesenchymal and Neural Stem Cell Combination Therapy for Ischemic Stroke 2Novastem Treats First Patient Using Stemedica's Mesenchymal and Neural Stem Cell Combination Therapy for Ischemic Stroke 3Novastem Treats First Patient Using Stemedica's Mesenchymal and Neural Stem Cell Combination Therapy for Ischemic Stroke 4Commonwealth Cornerstone Group Announces $8 Million in Tax Credits to Expand and Consolidate Healthcare Services in Sharon 2Commonwealth Cornerstone Group Announces $8 Million in Tax Credits to Expand and Consolidate Healthcare Services in Sharon 3Kinex Pharmaceuticals Announces First Patient Dosed with KX2-361 in a Phase 1 Clinical Study 2Kinex Pharmaceuticals Announces First Patient Dosed with KX2-361 in a Phase 1 Clinical Study 3
... OMER ) today announced that its exclusive license to ... been amended to include addiction and compulsive disorders in the ... Company,s discovery of a previously unknown link between PDE7 and ... it also is the first to link PDE7 to any ...
... BRUNSWICK, N.J. and LEIDEN, Netherlands, Feb. 22, 2011 Johnson ... (NYSE Euronext, Nasdaq: CRXL ; Swiss Exchange: CRX) ... offer for Crucell N.V. (Crucell) and has declared the offer ... center for vaccines within the Johnson & Johnson pharmaceuticals group. ...
Cached Medicine Technology:Omeros Announces Expansion of Exclusive License to PDE7 Inhibitors from Daiichi Sankyo 2Omeros Announces Expansion of Exclusive License to PDE7 Inhibitors from Daiichi Sankyo 3Omeros Announces Expansion of Exclusive License to PDE7 Inhibitors from Daiichi Sankyo 4Johnson & Johnson Completes Tender Offer for Crucell and Declares Offer Unconditional 2Johnson & Johnson Completes Tender Offer for Crucell and Declares Offer Unconditional 3Johnson & Johnson Completes Tender Offer for Crucell and Declares Offer Unconditional 4Johnson & Johnson Completes Tender Offer for Crucell and Declares Offer Unconditional 5Johnson & Johnson Completes Tender Offer for Crucell and Declares Offer Unconditional 6Johnson & Johnson Completes Tender Offer for Crucell and Declares Offer Unconditional 7Johnson & Johnson Completes Tender Offer for Crucell and Declares Offer Unconditional 8
(Date:12/24/2014)... 2014 Over 700 toys, that’s what ... communities. That is 700 smiling little faces this holiday ... over $6000 in monetary donations was given to the ... the expenses they incur through the year. Some of ... A Child's Haven , Shrine's Children's Hospitals, Toys for ...
(Date:12/24/2014)... TX (PRWEB) December 24, 2014 Connie ... specialist and functional medicine advocate with 30 years of ... trial to evaluate the health benefits of dietary detoxification. ... with new participants following excellent results from test patients ... When asked to explain her interest in conducting the ...
(Date:12/24/2014)... York, New York (PRWEB) December 24, 2014 ... to mount in a mass tort litigation currently underway ... LLP reports. As of December 24, 2014, court ... the proceeding on behalf of individuals who developed gynecomastia ... its use. Data from the Court indicates that this ...
(Date:12/24/2014)... TX (PRWEB) December 24, 2014 Dr. ... announced the expansion of his practice and med-spa with ... the practice’s growing list of cosmetic treatments and services. ... solution into the skin,” says Dr. Ho. “As a ... changes such as wrinkles, sun spots, discolorations or blemishes.” ...
(Date:12/24/2014)... Today, UWDress.com, the famous women’s dress supplier, has ... launched a site-wide wedding gown promotion. , For ... a more unexpected way, the collection should be a great ... global market, and they are available with custom service. , ... discounted prices, up to 75% off; most of them come ...
Breaking Medicine News(10 mins):Health News:AlignLife Donates Over 700 Toys This Year 2Health News:Connie Casad, MD, Now Accepting Test Participants for January Dietary Detoxification Study 2Health News:Connie Casad, MD, Now Accepting Test Participants for January Dietary Detoxification Study 3Health News:Risperdal Lawsuits Continue to Climb, as Claims in Pennsylvania Litigation Exceed 1,180 Filings, Bernstein Liebhard LLP Reports 2Health News:Risperdal Lawsuits Continue to Climb, as Claims in Pennsylvania Litigation Exceed 1,180 Filings, Bernstein Liebhard LLP Reports 3Health News:Risperdal Lawsuits Continue to Climb, as Claims in Pennsylvania Litigation Exceed 1,180 Filings, Bernstein Liebhard LLP Reports 4Health News:Dr. Vu Ho Expands Facial Plastic Surgery Practice to Include New Skin Care Treatment 2Health News:Buy Cheap Long Sleeve Wedding Gowns At UWDress.com 2
... WAUSAU, Wis., July 8 Like an estimated 5 million ... condition that greatly increases the risk of stroke and causes ... , , Aspirus cardiovascular surgeon John Johnkoski, M.D., ... Simonis to correct the condition that plagued the Rosholt resident ...
... with service, study finds , WEDNESDAY, July 8 (HealthDay ... new study says soldiers who need electrical spinal cord ... to return to active duty. , In electrical spinal ... help disrupt nerve signals for pain. The procedure, an ...
... SOUTH SAN FRANCISCO, Calif., July 8 ... a teleconference at 11:00 a.m. Eastern Time tomorrow, Thursday, ... deal in the past six months, this time for ... currently in Phase II clinical development for the prevention ...
... work conditions may be to blame for the decline in ... study published in the latest issue of the Annals ... are associated with stress, burnout and intent to leave for ... assistant professor in the department of medicine, Loyola University Chicago ...
... Foundation of America, Inc. (LFA) is accepting letters of intent ... transplantation research in humans as a treatment for lupus, and ... affect the health-related quality of life of children, adolescents and ... will award one $100,000 grant for adult stem cell research. ...
... LoJack Corporation (Nasdaq: LOJN ) and ... LoJack SafetyNet System and Project Lifesaver Program has helped to rescue ... Alzheimer,s or dementia who had wandered over the past month. ... with cognitive conditions at risk of wandering, and is a particularly ...
Cached Medicine News:Health News:Advanced Heart Procedure Treats Growing Problem 2Health News:Advanced Heart Procedure Treats Growing Problem 3Health News:Portola Pharmaceuticals to Host Conference Call at 11:00 a.m. Eastern Time Tomorrow to Discuss Betrixaban Partnership and Provide Corporate Update 2Health News:Health clinic conditions may be to blame for decrease in primary care physicians 2Health News:Lupus Foundation of America Accepting Letters of Intent for Research Grants on Adult Stem Cell Research and Health-Related Quality of Life in Pediatric Lupus 2Health News:LoJack SafetyNet and Project Lifesaver Help Rescue Clients Afflicted With Alzheimer's/Dementia Who Wandered 2Health News:LoJack SafetyNet and Project Lifesaver Help Rescue Clients Afflicted With Alzheimer's/Dementia Who Wandered 3Health News:LoJack SafetyNet and Project Lifesaver Help Rescue Clients Afflicted With Alzheimer's/Dementia Who Wandered 4Health News:LoJack SafetyNet and Project Lifesaver Help Rescue Clients Afflicted With Alzheimer's/Dementia Who Wandered 5
... The CKX microscopes utilize ... improved visibility and operability in ... a cost-effective inverted microscope suited ... range of fields--from tissue culture ...
The simplest, neatest, most efficient anti-theft system for frames and sunwear. Available in 3 colors Black, Matte aluminum, and Bronze. Fits with any style or color of furniture. Safe, simple, easy...
69" 5 shelves electric rotating display with gunmetal grey frame. Lead time 6-8 weeks....
1 Frame clear base post with transparent Eyevee 2.0 Clip....
Medicine Products: