HOME >> BIOLOGY >> NEWS
Phase III clinical program evaluates lubiprostone

BETHESDA, MD May 16, 2005 Takeda Pharmaceuticals North America (TPNA) and Sucampo Pharmaceuticals announced the initiation of a phase III clinical development program for lubiprostone in patients with constipation-predominant irritable bowel syndrome (IBS-C). Enrollment for these trials begins this month. Lubiprostone is an investigational compound currently being evaluated by the FDA for the treatment of chronic idiopathic constipation and associated pain and bloating in adults.

The IBS-C clinical development program will include two phase III trials. Each trial will examine more than 500 patients for 12 weeks to evaluate the safety and efficacy of lubiprostone.

"Irritable bowel syndrome is a condition that can impact a person's quality of life, but is currently addressed by few available therapies," said John Johanson, M.D., clinical associate professor, University of Illinois College of Medicine, and principal investigator. "Based on results from our phase II study, we believe lubiprostone may have the potential to treat IBS-C, and thus offer a new option for people living with irritable bowel syndrome."

The program includes two double-blind, randomized phase III clinical trials with a treatment period of 12 weeks, taking place at up to 130 sites around the United States. A previous phase II study in IBS-C patients evaluated the effectiveness across a range of doses. Additionally, studies of lubiprostone in chronic constipation have achieved clinical endpoints of relief of constipation and associated pain and bloating and demonstrated tolerability, regardless of gender.

Lubiprostone is a chloride channel activator, a novel compound with a unique mechanism of action. Taken orally, the agent has been shown to work locally and specifically in the GI tract by activating a specific chloride channel (CLC2). Chloride channels are proteins that carry chloride on cells lining the small intestine. When activated, these cells increase in
'"/>


16-May-2005


Page: 1 2

Related biology news :

1. Phase II study of therapeutic vaccine shows efficacy in patients with metastatic colorectal cancer
2. Biovest announces interim blinded data of fast-tracked pivotal Phase 3 clinical trial of BiovaxID
3. Oncolytics Biotech Inc. proceeds to initiate US Phase II sarcoma clinical trial
4. The Parkinsons Institute to conduct Phase III Clinical Trial of creatine for Parkinsons disease
5. Phase III trials of cellulose sulfate microbicide for HIV prevention closed
6. Phylonix awarded National Science Foundation Phase II SBIR for zebrafish screening
7. Kentucky first state to match federal SBIR-STTR Phase 1 and Phase 2 grants
8. Acorda announces positive Phase 3 Fampridine-SR study in people with multiple sclerosis
9. REMICADE Phase 3 data show rapid, significant, long-term psoriasis improvement
10. New Phase 3 data show potential benefits of Aranesp dosed every three weeks for CIA
11. Eisai announces Phase II data on E7389, a potential new therapy for the treatment of breast cancer

Post Your Comments:
*Name:
*Comment:
*Email:
TAG: Phase III clinical program evaluates lubiprostone

(Date:7/31/2014)... follow-up study (HPV-023; NCT00518336) shows the sustained ... papilloma virus (HPV) vaccine Cervarix. Women vaccinated ... for more than nine years, and vaccine ... This is the longest follow-up report for ... for the full paper. , ...
(Date:7/31/2014)... team of scientists from Spain, France, and the ... that is the oldest definitive member of the ... amber. The discovery and description were made possible ... synchrotron imaging technique, which allows the detailed study ... new species is described in the journal ...
(Date:7/31/2014)... Lincoln, Neb., July 31, 2014 -- Do people make ... their mothers raise them that way? Is it a ... of Nebraska-Lincoln and a colleague from Rice University say ... why some people lean left while others lean right. ... responses and deep-seated psychology are at the core of ...
Breaking Biology News(10 mins):Sustained efficacy, immunogenicity, and safety for GlaxoSmithKline's HPV vaccine 2Sustained efficacy, immunogenicity, and safety for GlaxoSmithKline's HPV vaccine 3Scientists find growing consensus: Political attitudes derive from body and mind 2
(Date:8/1/2014)... Aug. 1, 2014 Cambrex Corporation (NYSE: ... 30, 2014. Highlights , Second ... in the same period last year. , Second quarter ... in the same period last year (see table at the ... guidance increased, excluding the impact of foreign currency, to between ...
(Date:7/31/2014)... Food and natural product manufacturers, ... food alternatives that offer variety, as well as, ... market has numerous players operating in the marketplace ... Technology (VFT). VFT is a science-driven functional ... all tested to produce stable, effective and repeatable ...
(Date:7/31/2014)... CHICAGO , July 31, 2014 Nearly ... 65 th Annual Meeting & Clinical Lab Expo ... The meeting featured never-before-seen breakthroughs in diagnostic research and ... treatment they need. As of Wednesday, July ... 2014 AACC Annual Meeting & Clinical Lab Expo, with ...
(Date:7/31/2014)... even the entire body to visualize long-range connections between ... a long-time dream of biologists. A study published by ... Cell has now made that dream a ... and human tissue biopsies transparent, while keeping the cellular ... way for a better understanding of brain-body interactions, more ...
Breaking Biology Technology:Cambrex Reports Second Quarter 2014 Financial Results 2Cambrex Reports Second Quarter 2014 Financial Results 3Cambrex Reports Second Quarter 2014 Financial Results 4Cambrex Reports Second Quarter 2014 Financial Results 5Cambrex Reports Second Quarter 2014 Financial Results 6Cambrex Reports Second Quarter 2014 Financial Results 7Cambrex Reports Second Quarter 2014 Financial Results 8Cambrex Reports Second Quarter 2014 Financial Results 9Cambrex Reports Second Quarter 2014 Financial Results 10Cambrex Reports Second Quarter 2014 Financial Results 11Cambrex Reports Second Quarter 2014 Financial Results 12Cambrex Reports Second Quarter 2014 Financial Results 13Cambrex Reports Second Quarter 2014 Financial Results 14Cambrex Reports Second Quarter 2014 Financial Results 15Cambrex Reports Second Quarter 2014 Financial Results 16Functional Ingredient Manufacturer – Vital Force Technology Infuses Raw Materials & Ingredients with Subtle Energy Formula 2Research on Digital Health, Alzheimer's, Ebola Draws Nearly 20,000 Attendees to 2014 AACC Annual Meeting & Clinical Lab Expo 2Research on Digital Health, Alzheimer's, Ebola Draws Nearly 20,000 Attendees to 2014 AACC Annual Meeting & Clinical Lab Expo 3See-through organs and bodies will accelerate biomedical discoveries 2
Cached News: