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Mesalazine Modified-Release Tablet in the Treatment of Ulcerative Colitis in the Remission Phase: A Chinese, Multicenter, Single-Blind, Randomized Controlled Study

Abstract

Introduction

This study aimed to compare the efficacy and safety of two mesalazine formulations in the treatment of Chinese patients with ulcerative colitis (UC) in the remission phase.

Methods

In this multicenter, single-blind, randomized controlled study conducted from November 2010 to August 2012, 251 patients with UC from 18 hospitals were enrolled. The patients were randomized to treatment with mesalazine modified-release tablets (MR group, n = 126) or other enteric-coated tablets (EC group, n = 125), at 800 mg three-times daily for 48 weeks. The primary efficacy parameter was the rate of non-emergence of bloody stool. If the lower limit of the 95% confidence interval (CI) of the primary efficacy measure was over −10%, the modified-release tablets were considered non-inferior to the enteric-coated tablets. The secondary efficacy parameters included the period of non-emergence of bloody stool and the period of non-recurrence of UC. The incidences of adverse events and adverse drug reactions were compared between the two groups.

Results

At 48 weeks of maintenance treatment, the rates of non-emergence of bloody stool were 82.99% (95% CI 73.53–92.45%) and 73.30% (95% CI 64.04–82.56%) in the MR and EC groups, respectively, and the difference between the two groups was 9.69% (95% CI −1.15–20.53%). There was no significant difference in the period of non-emergence of bloody stool and the period of non-recurrence of UC between the two groups (P > 0.05). The incidences of adverse events were 48.78% (60/123) and 48.00% (60/125) in the MR and EC groups, respectively (P = 0.902). The incidences of adverse drug reactions were 16.26% (20/123) and 13.60% (17/125) in the MR and EC groups, respectively (P = 0.556).

Conclusion

Mesalazine modified-release tablets were non-inferior to the enteric-coated tablets and may be considered an effective and safe treatment alternative for the maintenance of remission in Chinese patients with UC.

Trial registration

ClinicalTrials.gov identifier: NCT01257399.

Funding

Tillotts Pharma AG.

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Acknowledgments

The general contents of this manuscript have been published in the Chinese Journal of Digestion 2015;35(4):256–9 (included here with permission) [14].

This study was funded by Tillotts Pharma AG. The article processing charges for this publication were funded by Tillotts Pharma AG. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval to the version to be published. We thank Yuichi Takano (Zeria Pharmaceutical Co., Ltd., Tokyo, Japan) for providing assistance in writing this paper. Editorial assistance in the preparation of this manuscript was provided by Dr. Michelle Belanger on behalf of Springer Healthcare Communications. Support for this assistance was funded by Tillotts Pharma AG.

We would like to thank the following doctors and hospitals for their contributions to this study: Prof. Ran Zhihua, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine; Prof. Li Zhaoshen, Changhai Hospital Affiliated to Second Military Medical University; Prof. Lu Lungen, Shanghai First People Hospital; Prof. Shen Xizhong, Zhongshan Hospital, Fudan University; Prof. Zhang Zhenyu, Nanjing First Hospital; Prof. Shi Ruihua, the First Hospital, Nanjing Medical University; Prof. Zou Xiaoping, Gulou Hospital, Nanjing University School of Medicine; Prof. Hou Xiaohua, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Prof. Luo Hesheng, Renmin Hospital of Wuhan University; Prof. Li Youming, The First Affiliated Hospital of College of Medicine, Zhejiang University; Prof. Cai Jianting, The Second Affiliated Hospital of College of Medicine, Zhejiang University; Prof. Xie Pengyan, Peking University First Hospital; Prof. Zhang Shutian and Prof. Wu Yongdong, Beijing Friendship Hospital, Capital Medical University; Prof. Hao Jianyu, Beijing Chao-Yang Hospital, Capital Medical University; Prof. Wang Bangmao, Tianjin Medical University General Hospital; Prof. Sheng Jianqiu, The Military General Hospital of Beijing PLA; and Prof. Li Liangping, Sichuan Provincial People’s Hospital.

Disclosures

Jing Sun has received honoraria from Tillotts Pharma AG. Yaozong Yuan has received honoraria from Tillotts Pharma AG. The authors declare no conflict of interest directly associated with the content of this manuscript.

Compliance with Ethics Standards

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964, as revised in 2013. Informed consent was obtained from all patients for being included in the study.

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Correspondence to Jing Sun.

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Sun, J., Yuan, Y. Mesalazine Modified-Release Tablet in the Treatment of Ulcerative Colitis in the Remission Phase: A Chinese, Multicenter, Single-Blind, Randomized Controlled Study. Adv Ther 33, 410–422 (2016). https://doi.org/10.1007/s12325-016-0304-y

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Keywords

  • China
  • Gastroenterology
  • Mesalazine
  • Randomized controlled trial
  • Remission phase
  • Ulcerative colitis