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Authors
Wada, Motoshi https://orcid.org/0000-0003-0413-4017
Nakamura, Shiro
Hayashi, Ayako
Otake, Rie
Miyamoto, Masakazu
Tanaka, Tomoko
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Clinical Trials BETA
Clinical trials referenced in this document:
nct05023382 at ClinicalTrials.govDocuments that mention this clinical trial
Six-Month Safety and Effectiveness of Teduglutide in Patients with Short Bowel Syndrome in Japan: Interim Analysis of Post-marketing Surveillance
https://doi.org/10.1007/s12325-025-03398-y
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Funding
Funding for this research was provided by:
Takeda Pharmaceutical Company
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More Information
Article History
Received: 28 September 2024
Accepted: 6 October 2025
First Online: 1 December 2025
Declarations
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: Motoshi Wada has received consulting fees and speakers’ fees from Takeda Pharmaceutical Company Limited. Shiro Nakamura has received speakers’ fees from AbbVie GK, EA Pharma Co., Ltd, Gilead Sciences, Inc., Janssen Pharmaceutical K.K., Kissei Pharmaceutical Co., Ltd, Kyorin Pharmaceutical Co., Ltd, Mitsubishi Tanabe Pharma Corporation, Mochida Pharmaceutical Co., Ltd, Pfizer Japan Inc., and Takeda Pharmaceutical Company Limited. Ayako Hayashi, Rie Otake, Masakazu Miyamoto, and Tomoko Tanaka are employees of Takeda Pharmaceutical Company Limited.
: The study was conducted in accordance with the principles of the Helsinki Declaration of 1964 and its later amendments, Good Post-marketing Study Practice (GPSP), and Good Vigilance Practice Ordinance. Although GPSP does not require approval by institutional review boards for post-marketing surveillance studies, the protocols and associated materials were reviewed and approved at those study sites that did require approval. Because this was a post-marketing surveillance study, and not an interventional study, patients were treated as part of their routine medical care, and informed consent was not required. However, patients, or their parent or legal guardian for pediatric patients, were required to provide written informed consent to agree to the publication of the study.
