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Randomised clinical trials: linaclotide phase 3 studies in IBS-C - a prespecified further analysis based on European Medicines Agency-specified endpoints.

Author: CheyW D, CurrieM G, DiazC, FalquesM, ForteaJ, JohnstonJ M, QuigleyE M M, RaoS S, ShiffS J, TackJ

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Overview

Linaclotide significantly improved abdominal pain and discomfort and the degree-of-relief of irritable bowel syndrome with constipation symptoms compared with placebo over 12 and 26 weeks.
Paper Details　
Original Abstract of the Article :
BACKGROUND: Treatment options that improve overall symptoms of irritable bowel syndrome with constipation (IBS-C) are lacking. AIM: A prespecified further analysis to evaluate the efficacy and safety of linaclotide, a guanylate cyclase C agonist, in patients with IBS-C, based on efficacy parameters...See full text at original site
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引用元：
https://doi.org/10.1111/apt.12123

データ提供：米国国立医学図書館（NLM）

Linaclotide: A Promising Treatment for Irritable Bowel Syndrome with Constipation (IBS-C)

This research delves into the critical area of finding effective treatments for IBS-C, a condition that affects many people. This study employed a rigorous, randomized, double-blind, multicenter Phase 3 trial design to investigate the efficacy and safety of linaclotide, a guanylate cyclase C agonist. The primary objective was to assess the effectiveness of linaclotide in patients with IBS-C, based on specific criteria defined by the European Medicines Agency (EMA). The researchers utilized two trials, one lasting 12 weeks and the other 26 weeks, to evaluate the impact of linaclotide on abdominal pain/discomfort and overall symptom relief.

Linaclotide Demonstrates Significant Improvements in IBS-C Symptoms

The results of this study reveal compelling evidence supporting the effectiveness of linaclotide for treating IBS-C. A significantly greater proportion of patients treated with linaclotide experienced relief from abdominal pain and discomfort compared to those receiving placebo. These positive effects were observed over both 12 and 26 weeks. The study also found that linaclotide significantly improved the overall degree of symptom relief, indicating a broader impact on IBS-C symptoms.

Linaclotide: A Potential Game-Changer for IBS-C Sufferers

This research suggests that linaclotide holds significant promise as a new and effective treatment for IBS-C. The significant improvements in abdominal pain and discomfort, combined with the overall improvement in symptom relief, highlight the potential benefits for patients struggling with this condition. It's important to note that, as with any medication, it's crucial to consult with a healthcare professional to determine the appropriate treatment plan and manage any potential side effects.

Dr. Camel's Conclusion

Imagine a scorching desert with a lone traveler searching for a cool oasis. This study is like finding that oasis—a beacon of hope for IBS-C sufferers seeking relief from their uncomfortable symptoms. Linaclotide's success in improving both abdominal pain and overall symptom severity makes it a potentially transformative treatment, offering a chance for individuals with IBS-C to enjoy a more comfortable and fulfilling life.
Date :
  1. Date Completed 2013-05-23
  2. Date Revised 2022-04-09
Further Info :

Pubmed ID

23116208

DOI: Digital Object Identifier

10.1111/apt.12123

Related Literature

Article Analysis
・Effective treatment of irritable bowel syndrome
SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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