Design of Treatment Trials for Functional Gastrointestinal Disorders

Author:

Irvine E. Jan,Tack Jan,Crowell Michael D.,Gwee Kok Ann,Ke Meiyun,Schmulson Max J.,Whitehead William E.,Spiegel Brennan

Publisher

Elsevier BV

Subject

Gastroenterology,Hepatology

Reference87 articles.

1. FDA and EMA end points: which outcome end points should we use in clinical trials in patients with irritable bowel syndrome?;Corsetti;Neurogastroenterol Motil,2013

2. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry: Irritable Bowel Syndrome−Clinical Evaluation of Drugs for Treatment. Available at: http://www.fda.gov/downloads/Drugs/Guidances/UCM205269.pdf. Published May 2012. Accessed January 10, 2015.

3. Guideline on the Evaluation of Medicinal Products for the Treatment of Irritable Bowel Syndrome. Vol 2014,2013

4. Clinical presentation and personality factors are predictors of the response to treatment in patients with functional dyspepsia; a randomized, double-blind placebo-controlled crossover study;Holtmann;Dig Dis Sci,2004

5. Potential biomarkers;Spiller;Gastroenterol Clin N Am,2011

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