Navigation Links
Labopharm reports results for Phase III study on twice-daily tramadol-acetaminophen formulation
Date:4/2/2009

LAVAL, QC, April 2 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced the results of its recently completed North American Phase III clinical trial for its twice-daily formulation of tramadol and acetaminophen (study 06CCL3-001).

Study 06CCL3-001 was a multi-centre, randomized, double-blind, parallel-arm study that compared the efficacy and safety of Labopharm's twice-daily tramadol-acetaminophen formulation to placebo in the treatment of moderate to severe acute low back pain. A total of 277 patients were included in the study. Thirteen percent (13%) of patients in the active treatment group discontinued early (12% due to adverse events) and 5% of patients in the placebo group discontinued early (2% due to adverse events).

Results of the efficacy measures in the study demonstrated a statistically significant difference from placebo in some cases but not in others. An analysis of covariance demonstrated a statistically significant difference from placebo on the Sum of Pain Intensity Differences (SPID) over 50 hours using LOCF (last observation carried-forward) as the imputation method, however, the results were not statistically significant using LOCF/BOCF (baseline observation carried-forward), the primary endpoint. A non-parametric analysis, however, demonstrated statistical significance using both LOCF and LOCF/BOCF as imputation methods. The difference from placebo on the Total Pain Relief (TOTPAR) score was also statistically significant using both LOCF and LOCF/BOCF imputation methods and the patients' global impression of the effectiveness of the study medication was statistically different from placebo. Statistical significance reflects a p-value of less than 0.05 in each of the analyses.

Regulatory authorities throughout the world have different requirements for the analysis and demonstration of efficac
'/>"/>

SOURCE Labopharm Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. Labopharm To Present Poster On Onset Of Analgesic Effect Of Once-Daily Tramadol At Congress Of The European Society Of Regional Anaesthesia And Pain Therapy
2. Labopharm provides update on U.S. regulatory process for once-daily Tramadol
3. Labopharm completes enrolment for Phase III clinical study for its once-daily trazodone antidepressant drug
4. Labopharm appeals FDAs decision on once-daily tramadol
5. Labopharm to host conference call Friday, November 9, 2007 at 8:30 a.m. (ET)
6. Labopharm to present at CIBC World Markets 18th Annual Healthcare Conference
7. Labopharm Reports Results for Third Quarter Fiscal 2007
8. Labopharm receives FDA response to appeal of Approvable Letter for once-daily tramadol
9. Labopharm enters into licensing and distribution agreement for once-daily tramadol in Australia with iNova
10. Canadian Marketing and Sales Effort for Labopharms Once-Daily Tramadol Product to Expand Significantly
11. Labopharm Reports Positive Results for Phase III Study on Once-daily Trazodone
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/3/2015)... June 03, 2015 Acne is the same ... be particularly stubborn to eliminate and hard to prevent. As ... in teens and young adults, in the years when the ... or oil,” says Jayme Bashian, director and lead medical aesthetician ... blackheads and cysts of acne are caused by oil and ...
(Date:6/3/2015)... Implant design can have a profound influence on the ... an implant surface. The unique triangular-shape of the V3 ... regeneration, resulting in the gain of greater volume of ... more esthetic restorations. , “It’s all in the shape”, ... triangular neck of the V3 provides solid anchorage at ...
(Date:6/3/2015)... DailyEndorphin is pleased to announce the ... With this highly configurable new offering, DE's annual clients ... components of its wellness programming for the entire year ... With this new module, annual clients may also do ... participant surveys, (3) Continually report on participant progress towards ...
(Date:6/3/2015)... Scanalytics ” was featured on NewsWatch as part of ... coolest technology products available to consumers. Andrew Tropeano, a ... review and shared with viewers how this technology allows ... Tracking statistics in business is invaluable in analyzing and ... goes a step beyond revenue statistics and tracking how ...
(Date:6/3/2015)... (PRWEB) June 03, 2015 Fit Body ... boot camp fitness program. The company helps thousands of individuals ... To encourage more people to hit the gym and get ... five tips for getting the most out any gym membership: ... part about committing to gym memberships is saying motivated and ...
Breaking Medicine News(10 mins):Health News:Back Acne: Tips for Clearer Summer Skin 2Health News:Back Acne: Tips for Clearer Summer Skin 3Health News:MIS Implants Launches Radically New V3 Dental Implant For Immediate Biological Benefits 2Health News:DailyEndorphin Launches Wellness "Events" Portal 2Health News:Technology to Analyze Foot Traffic in Retail Stores was featured on NewsWatch Television 2Health News:Summer Body Slim-Down: 5 Ways to Avoid Quitting Gym Memberships this Summer 2Health News:Summer Body Slim-Down: 5 Ways to Avoid Quitting Gym Memberships this Summer 3
... NEW YORK (Nov. 22 2009) -- Physician-scientists from Weill Cornell ... to be a powerful target for the treatment of non-Hodgkin,s ... blood cells. By exploiting this mechanism, researchers have been able ... animal models. Promising results have led to the design ...
... ... can be both fun and joyous. It can also be stressful and tiring ... foods -- factors that can, over time, increase your risk of cancer. That,s ... 10 Food Tips that can help ensure a happier, more healthful holiday season, ...
... , WASHINGTON, Nov. 21 DNC Chairman ... to begin full debate of health insurance reform legislation. ... Senate took another historic step on the road to enacting ... will now have an opportunity to debate the health reform ...
... , , Association Discusses Key ... Reform , ST. CHARLES, Ill., Nov. 21 ... Affordable Health Care for America Act (H.R. 3962), and the ... decisive steps to fix our nation,s broken health care system. ...
... , ... addictive game, SplitWords, is now available on the iPhone and iPod Touch. , ... Mountain View, CA (PRWEB) November 21, 2009 ... iPod Touch. Split Words is designed to help banish that ,tip of the tongue, syndrome ...
... , Pioneering Neurologist Closer to Understanding ... Dr. Jeremy Schmahmann, Professor of Neurology at Harvard Medical ... Boston, on Thursday, November 19, presented his laboratory,s research ... the launch of the MINDlink Foundation. , Dr. Schmahmann ...
Cached Medicine News:Health News:New cancer target for non-Hodgkin's lymphoma 2Health News:Top 10 Food Tips for the Holidays from the National Foundation for Cancer Research 2Health News:Top 10 Food Tips for the Holidays from the National Foundation for Cancer Research 3Health News:Democratic National Committee Chairman Tim Kaine's Statement on the Senate's Vote to Proceed to Full Floor Debate of Health Insurance Reform Legislation 2Health News:AARP Hosts Rep. Bill Foster In Health Care Reform Forum 2Health News:HAPPYneuron releases iPhone Brain Game 2Health News:HAPPYneuron releases iPhone Brain Game 3Health News:MINDlink Foundation Launches to Connect the Cerebellum to Cures 2
(Date:6/3/2015)...  SurgiQuest®, Inc. ("SurgiQuest", the "Company"), a leading ... surgery (MIS) announced today that surgeons have successfully ... Adoption has risen rapidly with a 150% growth ... the company,s expansion from robotics into the general ... over 45 countries.   The AirSeal ...
(Date:6/3/2015)... 2015 Research and Markets  ( http://www.researchandmarkets.com/research/rf4hfn/global ... "Global Neurodegenerative Diseases Market 2015-2019" report to ... market to grow at a CAGR of 4.77% ... covers the present scenario and the growth prospects ... period 2015-2019. To calculate the market size, the ...
(Date:6/3/2015)... , June 3, 2015  EIP Pharma LLC ... phase 2 clinical development of VX-745 in Alzheimer,s disease ... highly selective and potent inhibitor of the alpha isoform ... (p38 MAPK alpha). "Recent human genetic data ... in patients with symptomatic Alzheimer,s, while the science also ...
Breaking Medicine Technology:Rapid Procedure Growth With SurgiQuest's AirSeal System 2Global Neurodegenerative Diseases Market 2015-2019 - Reformulation of Marketed Drugs 2EIP Pharma announces first patient dosing in phase 2 clinical studies of a novel brain-targeted anti-inflammatory drug candidate, VX-745, for the treatment of Alzheimer's disease (AD) 2EIP Pharma announces first patient dosing in phase 2 clinical studies of a novel brain-targeted anti-inflammatory drug candidate, VX-745, for the treatment of Alzheimer's disease (AD) 3
... Karmanos Cancer,Institute physician-scientists today reported on two ... cancer at the American Association of Cancer ... Caucasian patients with endometrial or ovarian cancer, ... counterparts. Led,by Veronica Schimp, D.O., assistant professor ...
... Tanespimycin Shown to Have No Effect on QTc ... Kosan,Biosciences Incorporated today presented safety data from,preclinical and ... Serial electrocardiogram (ECG) monitoring,of patients was conducted in ... were conducted in more than 85,patients. Tanespimycin was ...
Cached Medicine Technology:Karmanos Physician-Scientists Examine Racial Disparities in,Patients with Gynecologic Cancer 2Karmanos Physician-Scientists Examine Racial Disparities in,Patients with Gynecologic Cancer 3Kosan Presents Data on Cardiac Safety Profile of Hsp90 Inhibitor,Tanespimycin (KOS-953) at AACR 2Kosan Presents Data on Cardiac Safety Profile of Hsp90 Inhibitor,Tanespimycin (KOS-953) at AACR 3Kosan Presents Data on Cardiac Safety Profile of Hsp90 Inhibitor,Tanespimycin (KOS-953) at AACR 4
Complete digital pulse oximetryanytime, anywhere, any patient....
... Medic 6 Defibrillator is a simple ... response that is compact with a ... portable at only 13.5 lbs. It ... 360 joules,It has full summary pre- ...
Biopsy forceps...
Incontinence Pessaries...
Medicine Products: