Gastroenterology
Volume 135, Issue 6 , Pages 1877-1891 , December 2008

Challenges to the Therapeutic Pipeline for Irritable Bowel Syndrome: End Points and Regulatory Hurdles

  • Michael Camilleri

      Affiliations

    • Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Mayo Clinic, Rochester, Minnesota
    • Corresponding Author InformationAddress requests for reprints to: Michael Camilleri, MD, Mayo Clinic, Charlton 8-110, 200 First Street, SW, Rochester, Minnesota 55905
    • ,
  • Lin Chang

      Affiliations

    • Center for Neurobiology of Stress, David Geffen School of Medicine at UCLA, VAGLAHS, Los Angeles, California

Received 18 June 2008 ,Accepted 4 September 2008.

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    The process recommended by the PRO guidance document for developing of new or for modifying existing instruments for clinical trials (reproduced from US Department of Health and Human Services FDA Cen

    The process recommended by the PRO guidance document for developing of new or for modifying existing instruments for clinical trials (reproduced from US Department of Health and Human Services FDA Center for Drug Evaluation and Research; US Department of Health and Human Services FDA Center for Biologics Evaluation and Research; US Department of Health and Human Services FDA Center for Devices and Radiological Health92).

 The authors disclose the following: Dr Camilleri reports consulting for Albireo, Tioga, Dynogen, Axcan, Procter & Gamble, SK Bio-Pharmaceuticals, and Salix. As a consultant with GlaxoSmithKline, he attended a meeting at the FDA in January 2008 regarding end points for irritable bowel syndrome. He has received research grants from Novartis, Theravance, Takeda/Sucampo, Johnson & Johnson, Bristol-Myers Squibb, as well as support for studies in irritable bowel syndrome from National Institutes of Health (RO1-DK-54681). Dr. Chang reports consulting for Albireo, GlaxoSmithKline, Forest, Ironwood, McNeil, Prometheus, Salix, Synergy, Takeda, and Tioga and research grant support from GlaxoSmithKline, Prometheus, Rose Pharma. She also receives funding from the National Institutes of Health for studies in irritable bowel syndrome (RO1 AR46122 and P50 DK64539).

PII: S0016-5085(08)01668-5

doi: 10.1053/j.gastro.2008.09.005

Gastroenterology
Volume 135, Issue 6 , Pages 1877-1891 , December 2008

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