- •Clinical trial design for abdominal and pelvic pain conditions is challenging.
- •A review of randomized clinical trial entry criteria and end points is provided.
- •Encouraged future research areas to inform trial design are discussed.
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The study was funded by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) Public-private Partnership. This article was reviewed and approved by the Executive Committee of the ACTTION public-private partnership with the United States Food and Drug Administration (FDA).
The views expressed in this article are those of the authors and no official endorsement by the FDA or the pharmaceutical and device companies that provided unrestricted grants to support the activities of the ACTTION public-private partnership should be inferred. Sawsan As-Sanie has received compensation for consulting from Abbvie and Daiichi Sankyo. Frank Tu has received compensation for consulting from and performed industry-sponsored trials for AbbVie. Katy Vincent has received honorarium for consulting from Bayer Healthcare and Grunenthal GmbH and hold an investigator initiated grant from Bayer Healthcare. In her capacity as a special government employee of the FDA, Ursula Wesselmann serves as a member of the FDA Anesthetic and Analgesic Drug Products Advisory Committee. Dr. Wesselmann has served as a consultant for Grünenthal GmbH and Ironwood Pharmaceuticals, Inc. The remaining authors have no conflicts of interest to declare.