Navigation Links
Microbia and Forest Laboratories Announce Preliminary Results of Linaclotide Phase 2b Studies
Date:3/4/2008

ull results for both completed studies, the companies intend to initiate Phase 3 trials in both CC and IBS-C patients in the second half of 2008.

CC Trial Design

The U.S. based Phase 2b study was designed to assess the safety, efficacy, and dose-response of linaclotide in patients with CC. The primary efficacy endpoint was the change in the overall mean weekly frequency of SBMs from the pre-treatment baseline through the four-week treatment period. Following a no-drug washout period of 14-17 days, patients (N=310, with equal randomization across treatment groups) were randomized to receive placebo or linaclotide once-daily in the morning at doses of 75 mcg, 150 mcg, 300 mcg or 600 mcg for 28 days. Following completion of the four weeks of double-blind treatment, patients were followed up for safety assessments for an additional two weeks. Bowel function measurements included the number of spontaneous and complete spontaneous bowel movements (CSBM) compared to baseline, stool consistency using the Bristol Stool Form Scale (BSFS), and straining. Patient-reported outcomes included measures of abdominal pain, abdominal discomfort, and bloating on a daily basis, and constipation severity and overall relief of constipation on a weekly basis. In addition, the use of rescue medication, end-of-treatment satisfaction, and disease-specific quality of life were assessed.

IBS-C Trial Design

The U.S. and Canadian based Phase 2b study was designed to assess the safety, efficacy, and dose-response of linaclotide in patients with IBS-C. The primary efficacy endpoint was the change in the overall mean weekly frequency of CSBMs from the pre-treatment baseline through the 12-week treatment period. Following a no-drug washout period of 14-17 days patients (N=420, with equal randomization across treatment groups) were randomized to receive placebo or linaclotide once-daily in the morning at doses of 75 mcg, 150 mcg, 300 mcg or 600 mcg for 12 weeks. Following c
'/>"/>

SOURCE Microbia, Inc. and Forest Laboratories, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. Congressional Funds Awarded for Testing of Antimicrobial Copper Metals
2. Further Data on Safety and Efficacy of Cethromycin Presented at 47th Interscience Conference on Antimicrobial Agents and Chemotherapy
3. D1 Sports Training Facilities Adopt TurfAide(TM) Antimicrobial to New Synthetic Turf Fields from AstroTurf(R)
4. Further Data on Safety and Efficacy of Cethromycin Presented at 47th Interscience Conference on Antimicrobial Agents and Chemotherapy
5. Promising Data from Paratek Pharmaceuticals MAR Inhibitor Program Presented in Late Breaker Session at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy
6. Keeping the Data Center Clean: ATEN Launches Industry-First KVM Switches with Antimicrobial Nanocoating to Protect Products from Bacteria Surviving on Surfaces
7. Advanced Life Sciences to Present Data on Selected Cethromycin Therapeutic Studies at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy
8. Federal Funding Awarded to Test Antimicrobial Properties of Copper Metals
9. Forest Laboratories, Inc. Announces Positive Results of LEXAPRO(R) Phase III Study in Adolescents With Major Depression
10. Forest Laboratories, Inc. and Gedeon Richter Announce Results of Phase II-B Study for RGH-188 as a Treatment for Schizophrenia
11. Daiichi Sankyo and Forest Laboratories Finalize Contract for Co-Promotion of AZOR(TM)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/31/2015)... CHICAGO , July 31, 2015 ... Composition Analyzers Market by Product (Bioimpedance Analyzers (BIA), Dual-Energy ... and Hydrostatic Weighing) - Global Analysis & Forecast to ... Market was pegged at $911.1 Million 2014 and is ... at a CAGR of 9.4% from 2014 to 2019. ...
(Date:7/30/2015)... SAN DIEGO , July 30, 2015 ... announced it has signed a definitive agreement ... provider of non-invasive ventilation and sleep-disordered breathing ... strong clinical, innovation and market reputation in China, combined with ResMed,s global leadership ... of people in China ...
(Date:7/30/2015)... 2015  EP Global Communications, Inc. (Public OTC: EPGL) announced ... the Company about discussing EPGL,s electronic contact lens ... August 3, 2015.  Novartis CEO Joe Jimenez ... coming electronic contact lens market could be worth ... several years.  Novartis partnered with Google in 2014 ...
Breaking Medicine Technology:Body Composition Analyzers Market Worth $1,425.7 Million by 2019 2Body Composition Analyzers Market Worth $1,425.7 Million by 2019 3Body Composition Analyzers Market Worth $1,425.7 Million by 2019 4ResMed Invests in High-Growth Chinese Sleep and Respiratory Care Market with Curative Medical 2ResMed Invests in High-Growth Chinese Sleep and Respiratory Care Market with Curative Medical 3
(Date:8/3/2015)... Angeles, CA (PRWEB) , ... August 03, 2015 , ... ... has emerged among U.S. emergency rooms in recent years, according to the American Dental ... the number of dental emergency visits went from 1.1 million in a single year ...
(Date:8/3/2015)... ... August 03, 2015 , ... From ... by 39 percent, according to market research compiled for the National Association of ... U.S. Department of Labor, Bureau of Labor Statistics. As the number of dental ...
(Date:8/3/2015)... ... ... Dignity Health named Dr. Norris A. Baldwin, Jr. the Facility Medical Director ... August. The new facility is licensed under Dignity Health Arizona General Hospital ... is an excellent leader and will ensure our new freestanding emergency room delivers the ...
(Date:8/3/2015)... (PRWEB) , ... August 03, 2015 , ... Constantin Vasilica, ... accompanied by tissue injury caused by diabetes after many years of suffering and using ... times, and he didn’t want to ask for extra time off or wait longer ...
(Date:8/3/2015)... ... August 03, 2015 , ... Foot and Ankle Specialists of the ... creating the largest medical practice in the Mid-Atlantic region – and the second largest ... locations with 33 doctors. , Dr. Hetal Kathrotiya-Mago is a Maryland native. She grew ...
Breaking Medicine News(10 mins):Health News:Los Angeles Periodontists Comment on Rising Dental Emergency Room Trips 2Health News:Los Angeles Periodontists Comment on Rising Dental Emergency Room Trips 3Health News:Dental Association Announces Impending Reduction of Dental Laboratories Could Impact Dentists 2Health News:Dental Association Announces Impending Reduction of Dental Laboratories Could Impact Dentists 3Health News:Dignity Health Names Dr. Norris A. Baldwin, Jr. Facility Medical Director of New Freestanding Emergency Room 2Health News:Dignity Health Names Dr. Norris A. Baldwin, Jr. Facility Medical Director of New Freestanding Emergency Room 3Health News:Chinese Health Care Provider Heshoutang Now Give Patients Complimentary Online Healing Options 2Health News:Chinese Health Care Provider Heshoutang Now Give Patients Complimentary Online Healing Options 3Health News:Leading Foot and Ankle Medical Practice Adds Three New Podiatrists 2Health News:Leading Foot and Ankle Medical Practice Adds Three New Podiatrists 3Health News:Leading Foot and Ankle Medical Practice Adds Three New Podiatrists 4
... production ... efficiency, ... premier supplier of Storage and Server Platforms,for OEMs, Systems Integrators and ... PeSAN(TM) Technology,has been in use at HoneyShed ( http://www.honeyshed.com ) as ...
... bottle-fed, researchers noted , , TUESDAY, May 13 (HealthDay News) ... year reduce their risk of rheumatoid arthritis (RA) by ... researchers also found that having children but not breast-feeding ... oral contraceptives also failed to reduce the risk of ...
... LAKE CITY, May 13 Paramed Systems today announced,the ... (MOV) chair, a fully motorized stair climbing chair to ... The use of the MOV chair on,drilling platforms will ... to the helipad platform., Paramed developed the dual-track ...
... review of trends in,weight loss research suggests the ... loss, according to Edward Zbella, M.D.,Medical Director of ... strategies in combination with a personal, team approach,appears ... NBC,s hit show The Biggest Loser may not ...
... Performance during Sports or Play, CARLSBAD, Calif., May ... and retailer of custom-fitted arch supports and,natural sponge rubber ... of arch supports designed specifically for children ages 6 ... "SportFlex," are now,currently available at participating Good Feet Stores ...
... Lumenis Inc., a global,developer, manufacturer and seller ... aesthetic, and ophthalmic applications, announced,today the launch ... Prostate (HoLEP),preceptor program that will provide training ... and performing HoLEP. The abundance of,clinical evidence ...
Cached Medicine News:Health News:JMR Electronics BlueStor(TM) Storage Array Empowers HoneyShed's Post Production Process 2Health News:JMR Electronics BlueStor(TM) Storage Array Empowers HoneyShed's Post Production Process 3Health News:JMR Electronics BlueStor(TM) Storage Array Empowers HoneyShed's Post Production Process 4Health News:Breast-feeding Might Shield Women From Rheumatoid Arthritis 2Health News:Research Converging in Favor of New Approach to U.S. Weight Problem 2Health News:Good Feet Announces New Arch Support Product Line for Children Ages 6 and Older 2Health News:Lumenis Launches HoLEP Preceptor Program at American Urology Association 2008 Annual Meeting 2Health News:Lumenis Launches HoLEP Preceptor Program at American Urology Association 2008 Annual Meeting 3
The ENDO CLOSE™ trocar site closure device has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites....
... of a 42" long suture inserted into a ... one end and scored on the other. The ... to a ST-3 needle. The opposite end of ... of the plastic tube. The scored end acts ...
... long ligature inserted into a plastic tube. The plastic ... the other. The suture protrudes from the narrow end ... knot which becomes secure after the device is activated. ... the scored end of the plastic tube. The scored ...
... consists of 18'' long ligature inserted into a plastic ... and scored on the other. The suture protrudes from ... loop with a knot which becomes secure after the ... is fastened to the scored end of the plastic ...
Medicine Products: