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Ironwood and Forest Present Additional Positive Phase 2b Study Results for Linaclotide in Patients With Irritable Bowel Syndrome With Constipation
Date:5/31/2009

nal linaclotide presentations being made this week at DDW will be:

  • Abstract 236: Global Endpoints in IBS Clinical Trials: Results from a Phase 2b Study of Linaclotide, an oral presentation by Jeffrey Johnston, M.D., F.A.C.P., F.A.C.G. on Sunday, May 31 at 2:30 p.m. CT; McCormick Place, Room E352
  • Abstract 418: Effect of Linaclotide on Quality of Life in Adults with Chronic Constipation: Results from a Phase 2b Study, an oral presentation by Bernard J. Lavins, M.D. on Monday, June 1 at 2:15 p.m. CT; McCormick Place, Room S406A
  • Abstract 1273: Time to Onset of Linaclotide Effect on the Bowel Habits in Patients with Chronic Constipation: Results from a Phase 2b Study, a poster presentation by Jeffrey Johnston, M.D., F.A.C.P., F.A.C.G. on Tuesday, June 2 from 8:00 a.m. to 5:00 p.m. CT; McCormick Place, South Hall

Ironwood and Forest presented the initial analyses from both the IBS-C and CC studies last year.

IBS-C Phase 2b Study Design

This North American-based, randomized, multi-center, double-blind, placebo-controlled, dose-range-finding, parallel-group 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 change from baseline in complete spontaneous bowel movement (CSBM) frequency. The study evaluated the effects of 75, 150, 300, or 600 ug linaclotide or placebo administered orally once daily to adults meeting modified Rome II criteria for IBS-C. Participants underwent a two-week pretreatment (baseline) period before undergoing the 12-week treatment period, followed by a two-week post-treatment period. Daily assessments of bowel habits and symptom severity, and weekly global assessments were performed using an interactive voice response system. During the baseline period patients had to demonstrate <3
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SOURCE Forest Laboratories, Inc.; Ironwood Pharmaceuticals, Inc.
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Related medicine technology :

1. Ironwood Announces Linaclotide European Licensing Agreement with Almirall
2. Ironwood and Forest Present Positive Phase 2b Study Results for Linaclotide in Patients With Irritable Bowel Syndrome With Constipation
3. Ironwood and Collaborators Present Preclinical Data Demonstrating That Cyclic GMP Alleviates Intestinal Pain
4. Ironwood Raises $50 Million to Advance Linaclotide Through Phase 3
5. Ironwood and Forest to Present Positive Data From Linaclotide Phase 2b IBS-C Study at ACG Annual Scientific Conference
6. Ironwood Pharmaceuticals and Forest Laboratories Announce Presentation of Linaclotide Phase 2b Chronic Constipation Study Results
7. Forest Laboratories, Inc. and Laboratorios Almirall, S.A. Provide an Update on the Aclidinium Bromide Clinical Development Program
8. Forest Laboratories, Inc. and Cypress Bioscience, Inc. Announce Positive Results of Phase III Study of Milnacipran for the Management of Fibromyalgia
9. Forest Laboratories, Inc. and Gedeon Richter Plc Announce Positive Phase II Results with the Investigational Antipsychotic Cariprazine in Patients with Acute Mania Associated with Bipolar I Disorder
10. Forest Laboratories Announces Positive Results from Phase III Clinical Studies of Ceftaroline for the Treatment of Complicated Skin and Skin Structure Infections
11. Forest and Almirall Announce Positive Results of Clinical Studies for Aclidinium Bromide, a Novel, Long-Acting Anticholinergic for the Treatment for COPD
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