Navigation Links
Butrans® (Buprenorphine) Transdermal System CIII Pivotal Phase 3 Data Published in the Journal of Pain and Symptom Management
Date:10/26/2011

s multi-center, randomized, double-blind, placebo-controlled, parallel-group study employed an enriched design which included a run-in phase of up to 27 days in which 1,024 opioid-naive patients with moderate-to-severe chronic low back pain who were suboptimally responsive to their non-opioid therapy received open-label treatment with Butrans.  

Opioid-naive patients were defined as patients who were receiving less than 5 mg of oxycodone or the equivalent in the 14 days prior to screening, and who did not have a history of daily opioid use of greater than or equal to 5 mg of oxycodone or the equivalent for three months prior to screening, and who, in the opinion of the investigator, were not opioid dependent at time of entry to the study, had not benefitted from or had not tolerated non-opioid therapy, and were deemed to be appropriate candidates for an around-the-clock opioid analgesic regimen.  

Of the 1,024 patients who entered the open-label, dose-titration period, 53% were able to titrate to a tolerable and effective dose of Butrans and were randomized into a 12-week, double-blind treatment period.  Twenty-three percent (23%) of patients discontinued due to an adverse event from the open-label titration period and 14% discontinued due to lack of a therapeutic effect.  Of the patients who were randomized, the mean (SE) Numerical Rating Scale pain scores were 7.2 (0.08) and 7.2 (0.07) at screening and 2.6 (0.08) and 2.6 (0.07) at pre-randomization (beginning of double-blind phase) for the Butrans and placebo groups, respectively.

A total of 541 patients were randomized to receive Butrans (10 or 20 mcg/hour, N=257) or placebo (N=284) in a double-blinded fashion, based on tolerability and analgesic response at the end of the open-label titration period.  During the first seven days of double-blind treatment patients were allowed up to two tablets per day of immediate-release oxycodone 5 mg as supplemental analgesia to m
'/>"/>

SOURCE Purdue Pharma L.P.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Results of a Pivotal Phase 3 Efficacy and Safety Study for Butrans® (Buprenorphine) Transdermal System CIII Published in The Journal of Pain
2. Purdue Pharma L.P. to Present Data From Clinical Program for Butrans™ (buprenorphine) Transdermal System CIII at PAINWeek® 2010
3. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
4. Phosphagenics to Conduct a Phase 1 Transdermal Oxycodone Clinical Trial
5. Neupro(R) (Rotigotine Transdermal System) Effective in Controlling Early Morning Motor Impairment and Generally Well-Tolerated for Long-Term Use in Patients with Parkinsons Disease
6. Rotigotine Transdermal System Shows Significant Symptom Reduction and Tolerability in Patients with Restless Legs Syndrome
7. Long-Term 12-Month Safety Data Presented on ADHD Patch DAYTRANA(TM) (methylphenidate transdermal system)
8. Echo Therapeutics Announces Positive Results with the Prelude(TM) SkinPrep System, the Next-Generation Skin Permeation Medium for its Symphony(TM) Transdermal Continuous Glucose Monitoring System
9. New Analysis in Boys and Girls Shows the ADHD Patch, DAYTRANA(TM) (methylphenidate transdermal system), Offered ADHD Symptom Control for 12 Months
10. Echo Therapeutics Initiates Clinical Study of Its Symphony(TM) Transdermal Continuous Glucose Monitoring System in Patients with Type 1 and Type 2 Diabetes
11. Echo Therapeutics Announces Publication of Positive Clinical Data for its Symphony Transdermal Continuous Glucose Monitoring System in Journal of Diabetes Science and Technology
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/19/2014)... Fla. , Dec. 19, 2014 Breckenridge ... a multi-product agreement with MSN Laboratories Pvt. Ltd. ( ... MSN expect to commercialize several new ANDAs.  Under the ... supply the products exclusively to Breckenridge for the U.S. ... under its label.  Breckenridge and MSN have agreed to ...
(Date:12/19/2014)... , Dec. 19, 2014  Monarch America Inc. (OTCQB: ... Corp.) is pleased to provide this review of the ... in 2015. "Over this past year, we ... I am extremely proud to say that Monarch America ... than it has ever been," stated Eric Hagen ...
(Date:12/19/2014)... DUBLIN , Dec. 18, 2014 Research ... announced the addition of the "Micro Market ... report to their offering. ... dermatological treatment is progressing steadily, which has resulted ... diagnostic devices market. The main purpose of these ...
Breaking Medicine Technology:Breckenridge Pharmaceutical signs Multi-Product Generic Agreement with MSN Laboratories Pvt. Ltd. 2Monarch America Inc. CEO Reviews Recent Achievements and Provides Outlook for 2015 2Monarch America Inc. CEO Reviews Recent Achievements and Provides Outlook for 2015 3Micro Market Monitor: North American Dermatology Diagnostic Devices Market 2Micro Market Monitor: North American Dermatology Diagnostic Devices Market 3
... 2007 - Geron,Corporation (Nasdaq:GERN) today announced the ... company's human,embryonic stem cell (hESC)-based therapeutic for ... direct attack by the human immune,system., Presented ... Federation of,Clinical Immunology Societies meeting in San ...
... BETHESDA, Md., June 11, 2007--New research supported ... of Arthritis and,Musculoskeletal and Skin Diseases (NIAMS) ... which is used for certain,types of seizures, ... pain and,other symptoms associated with the common, ...
Cached Medicine Technology:Research Indicates Geron's Human Embryonic Stem Cell-Based,Therapeutic for Spinal Cord Injury Evades Direct Attack by the,Human Immune System 2Research Indicates Geron's Human Embryonic Stem Cell-Based,Therapeutic for Spinal Cord Injury Evades Direct Attack by the,Human Immune System 3Gabapentin Shown Effective for Fibromyalgia Pain 2Gabapentin Shown Effective for Fibromyalgia Pain 3
(Date:12/20/2014)... MissyDress, a distinguished special dress supplier, ... The business has drastically cut prices to all its ... until Jan. 30, 2015. Many of the hottest styles ... dresses, lace dresses, and more. , A spokesman for ... day. Whether A-line princess prom dresses or sweetheart chiffon ...
(Date:12/20/2014)... New York, NY (PRWEB) December 20, 2014 ... with the healthcare sector have benefited the Massage ... Given the discretionary characteristics of industry products, the anticipated ... the five-year period has provided consumers with the means ... adults that have received a massage in a given ...
(Date:12/20/2014)... York, NY (PRWEB) December 20, 2014 ... that allege a metal-on-metal version of the artificial ... forward in state and federal courts, Bernstein Liebhard ... New Jersey’ Bergen County Superior Court on December ... permitted to begin deposition of plaintiffs on November ...
(Date:12/20/2014)... 2014 (HealthDay News) -- The holidays can be anything ... with fresh trees, scented candles and other allergy triggers. ... decorations that have been packed away in dank basements ... and asthma patients," Dr. Rachna Shah, an affiliate faculty ... said in Loyola news release. Shah, who is ...
(Date:12/20/2014)... 2014 The Doctor’s Office Urgent Care of ... part of a decade. They’ve treated over 40,000 patients ... healthcare alternative to the Paramus area. , ... additions to their staff of top-notch board certified physicians: Christine ... These new doctors will work tirelessly to carry ...
Breaking Medicine News(10 mins):Health News:MissyDress: The Prices of Prom Dresses Just Reduced 2Health News:Massage Services in the US Industry Market Research Report from IBISWorld Has Been Updated 2Health News:Massage Services in the US Industry Market Research Report from IBISWorld Has Been Updated 3Health News:New Jersey Court Overseeing DePuy Pinnacle Hip Lawsuits Issues New Order, Bernstein Liebhard LLP Reports 2Health News:New Jersey Court Overseeing DePuy Pinnacle Hip Lawsuits Issues New Order, Bernstein Liebhard LLP Reports 3Health News:New Jersey Court Overseeing DePuy Pinnacle Hip Lawsuits Issues New Order, Bernstein Liebhard LLP Reports 4Health News:Holiday Trimmings Can Trigger Allergies 2Health News:The Doctor's Office Urgent Care Adds 3 New Physicians to Their Growing Medical Team 2
... (Vienna, Austria)-- Against the backdrop of some of the ... Central Asia, a report launched today at the XVIII ... case for a new model for scaling up treatment ... The report, "Prevention and Treatment of HIV/AIDS ...
... PHILADELPHIA, PA (July 21, 2010) -- A new approach ... of ten or more the amount of radiation patients ... the University of California, San Diego. Cone beam ... (IGRT), a state-of-the-art cancer treatment. IGRT uses repeated scans ...
... years ago, the medical establishment believed cancer was caused by ... vogue. Now, scientists are again looking at metabolism and its ... highly connected network of reactions that are arranged in parallel ... are linked with disease traits and make it difficult to ...
... -- Chaos models may someday help model cardiac arrhythmias -- ... journal CHAOS, which is published by the American ... more attention to chaos in cardiac dynamics. Although chaos marks ... chaos and watching it develop might allow researchers to predict, ...
... Lancet Series on HIV in people who use ... International AIDS conference in Vienna, reports that in order ... users (IDUs), health providers must focus less on the ... on conditions of health delivery that create treatment interruptions. ...
... Austria, July 21 Most older gay and bisexual men ... infrequently over a 10-year period, report University of Pittsburgh ... International AIDS Conference. The study explored the drug ... men, ages 44 to 63, enrolled in the Pitt Men,s ...
Cached Medicine News:Health News:New global report launched by the International AIDS Society recommends a new paradigm for treating injecting drug users: 'Seek, test, treat and retain' 2Health News:New global report launched by the International AIDS Society recommends a new paradigm for treating injecting drug users: 'Seek, test, treat and retain' 3Health News:New global report launched by the International AIDS Society recommends a new paradigm for treating injecting drug users: 'Seek, test, treat and retain' 4Health News:Video game processors help lower CT scan radiation 2Health News:Improved treatment access requires end to portrayal of drug abusers as already dead 2Health News:Improved treatment access requires end to portrayal of drug abusers as already dead 3Health News:Most men in long-term study of HIV report low use of illicit drugs 2
Inquire...
... incubators,Two refrigerated incubators that are ... life cycle,testing. Microprocessor controlled heating ... display. High/low audible and visual ... internal chamber safety thermostat,provides over-temperature ...
Inquire...
Inquire...
Medicine Products: