TY - JOUR
T1 - Drugs targeting functional bowel disorders
T2 - Lessions from drug trials
AU - Camilleri, Michael
N1 - Funding Information:
This work was supported in part by grants #RO1-DK54681 and #K24-DK-02638 from the National Institutes of Health. I wish to thank Cindy Stanislav for excellent secretarial assistance. M Camilleri has received research grants to perform single-center mechanistic studies on novel medications and has been an advisor to pharmaceutical companies on the study design and conduct of phase II and phase III trials. He or Mayo Foundation has received compensation on a daily rate for this work, as approved by Mayo Foundation's Medical/Industry Relations Committee. M Camilleri is a member of the Advisory Committee on Gastrointestinal Drugs of the Food and Drug Administration. The opinions expressed here are personal and have not been reviewed or endorsed by the Food and Drug Administration.
PY - 2002/12/1
Y1 - 2002/12/1
N2 - Recent insights in the field of functional gastrointestinal disorders have opened the way for novel pharmacological treatments directed at the central nervous system or peripheral targets. Now, universally accepted guidelines on therapeutic trial design and in the conduct and reporting of results of large clinical trials in these functional disorders are required. Several lessons have been learned from recent clinical and pharmacological trials of novel agents in irritable bowel syndrome and diabetic dyspepsia. Approaches that carefully characterize the pharmacokinetics, mechanism of action and pharmacodynamics of a drug, and that select subgroups of patients after a thorough understanding of the drug's effects, should facilitate and enhance the likelihood of accurate assessment of potential therapies.
AB - Recent insights in the field of functional gastrointestinal disorders have opened the way for novel pharmacological treatments directed at the central nervous system or peripheral targets. Now, universally accepted guidelines on therapeutic trial design and in the conduct and reporting of results of large clinical trials in these functional disorders are required. Several lessons have been learned from recent clinical and pharmacological trials of novel agents in irritable bowel syndrome and diabetic dyspepsia. Approaches that carefully characterize the pharmacokinetics, mechanism of action and pharmacodynamics of a drug, and that select subgroups of patients after a thorough understanding of the drug's effects, should facilitate and enhance the likelihood of accurate assessment of potential therapies.
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U2 - 10.1016/S1471-4892(02)00224-2
DO - 10.1016/S1471-4892(02)00224-2
M3 - Review article
C2 - 12482731
AN - SCOPUS:0036902492
SN - 1471-4892
VL - 2
SP - 684
EP - 690
JO - Current Opinion in Pharmacology
JF - Current Opinion in Pharmacology
IS - 6
ER -