Efficacy and safety of UI05MSP015CT in functional dyspepsia: A randomized, controlled trial

Hyuk Yoon, Dong Ho Lee, Yong Hyun Lee, Ju Cheol Jeong, Soo Teik Lee, Myung Gyu Choi, Seong Woo Jeon, Ki Nam Shim, Gwang Ho Baik, Jae Gyu Kim, Jeong Seop Moon, In Kyung Sung, Sang Kil Lee, Poong Lyul Rhee, Hwoon Yong Jung, Bong Eun Lee, Hyun Soo Kim, Sang Gyun Kim, Kee Myung Lee, Jae Kyu SeongJin Seok Jang, Jong Jae Park

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Background/Aims: To evaluate the efficacy and safety of a controlled release, once-daily formulation of mosapride (UI05MSP015CT) in patients with functional dyspepsia (FD). Methods: Patients with FD were randomly assigned (1:1) to receive either UI05MSP015CT (15 mg once a day, study group) or mosapride (5 mg three times a day, control group) and corresponding placebo for 4 weeks. The primary endpoint was a change in the gastrointestinal symptom score (GIS) evaluated at enrollment and after 4 weeks. Secondary endpoints were changes in the Nepean Dyspepsia Index-Korean version (NDI-K), rate of satisfactory symptom relief, and rate of adverse events. Results: A total of 138 patients were enrolled (female, 73.9%; mean age, 44.0±15.4 years). After excluding patients who violated the study protocol, 59 and 58 patients from the study and control groups, respectively, were included in the per-protocol analysis. No difference was observed in drug compliance between the control and study groups (97.07%±4.52% vs 96.85%±6.05%, p=0.870). Changes in GIS scores were –9.69±6.44 and –10.01±5.92 in the study and control groups. The mean difference in GIS change between groups was 0.33 (95% confidence interval, –1.75 to 2.41), demonstrating non-inferiority of UI-05MSP015CT (p=0.755). The rate of satisfactory symptom relief was not different between the study and control groups (39.0% vs 56.9%, p=0.053). No differences in change in NDI-K score (14.3 vs 16.9, p=0.263) or rates of adverse events (12.9% vs. 4.4%, p=0.062) were observed between the study and control groups. Conclusions: Once-daily mosapride is not inferior to conventional mosapride in efficacy and is safe in patients with FD.

Original languageEnglish
Pages (from-to)516-522
Number of pages7
JournalGut and Liver
Volume12
Issue number5
DOIs
Publication statusPublished - 2018 Sep 1

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Dyspepsia
Randomized Controlled Trials
Safety
Control Groups
Placebos
Confidence Intervals
mosapride
Pharmaceutical Preparations

Keywords

  • Compliance
  • Efficacy
  • Functional dyspepsia
  • Mosapride
  • Randomized clinical trial

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

Efficacy and safety of UI05MSP015CT in functional dyspepsia : A randomized, controlled trial. / Yoon, Hyuk; Lee, Dong Ho; Lee, Yong Hyun; Jeong, Ju Cheol; Lee, Soo Teik; Choi, Myung Gyu; Jeon, Seong Woo; Shim, Ki Nam; Baik, Gwang Ho; Kim, Jae Gyu; Moon, Jeong Seop; Sung, In Kyung; Lee, Sang Kil; Rhee, Poong Lyul; Jung, Hwoon Yong; Lee, Bong Eun; Kim, Hyun Soo; Kim, Sang Gyun; Lee, Kee Myung; Seong, Jae Kyu; Jang, Jin Seok; Park, Jong Jae.

In: Gut and Liver, Vol. 12, No. 5, 01.09.2018, p. 516-522.

Research output: Contribution to journalArticle

Yoon, H, Lee, DH, Lee, YH, Jeong, JC, Lee, ST, Choi, MG, Jeon, SW, Shim, KN, Baik, GH, Kim, JG, Moon, JS, Sung, IK, Lee, SK, Rhee, PL, Jung, HY, Lee, BE, Kim, HS, Kim, SG, Lee, KM, Seong, JK, Jang, JS & Park, JJ 2018, 'Efficacy and safety of UI05MSP015CT in functional dyspepsia: A randomized, controlled trial', Gut and Liver, vol. 12, no. 5, pp. 516-522. https://doi.org/10.5009/gnl17416
Yoon, Hyuk ; Lee, Dong Ho ; Lee, Yong Hyun ; Jeong, Ju Cheol ; Lee, Soo Teik ; Choi, Myung Gyu ; Jeon, Seong Woo ; Shim, Ki Nam ; Baik, Gwang Ho ; Kim, Jae Gyu ; Moon, Jeong Seop ; Sung, In Kyung ; Lee, Sang Kil ; Rhee, Poong Lyul ; Jung, Hwoon Yong ; Lee, Bong Eun ; Kim, Hyun Soo ; Kim, Sang Gyun ; Lee, Kee Myung ; Seong, Jae Kyu ; Jang, Jin Seok ; Park, Jong Jae. / Efficacy and safety of UI05MSP015CT in functional dyspepsia : A randomized, controlled trial. In: Gut and Liver. 2018 ; Vol. 12, No. 5. pp. 516-522.
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abstract = "Background/Aims: To evaluate the efficacy and safety of a controlled release, once-daily formulation of mosapride (UI05MSP015CT) in patients with functional dyspepsia (FD). Methods: Patients with FD were randomly assigned (1:1) to receive either UI05MSP015CT (15 mg once a day, study group) or mosapride (5 mg three times a day, control group) and corresponding placebo for 4 weeks. The primary endpoint was a change in the gastrointestinal symptom score (GIS) evaluated at enrollment and after 4 weeks. Secondary endpoints were changes in the Nepean Dyspepsia Index-Korean version (NDI-K), rate of satisfactory symptom relief, and rate of adverse events. Results: A total of 138 patients were enrolled (female, 73.9{\%}; mean age, 44.0±15.4 years). After excluding patients who violated the study protocol, 59 and 58 patients from the study and control groups, respectively, were included in the per-protocol analysis. No difference was observed in drug compliance between the control and study groups (97.07{\%}±4.52{\%} vs 96.85{\%}±6.05{\%}, p=0.870). Changes in GIS scores were –9.69±6.44 and –10.01±5.92 in the study and control groups. The mean difference in GIS change between groups was 0.33 (95{\%} confidence interval, –1.75 to 2.41), demonstrating non-inferiority of UI-05MSP015CT (p=0.755). The rate of satisfactory symptom relief was not different between the study and control groups (39.0{\%} vs 56.9{\%}, p=0.053). No differences in change in NDI-K score (14.3 vs 16.9, p=0.263) or rates of adverse events (12.9{\%} vs. 4.4{\%}, p=0.062) were observed between the study and control groups. Conclusions: Once-daily mosapride is not inferior to conventional mosapride in efficacy and is safe in patients with FD.",
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T1 - Efficacy and safety of UI05MSP015CT in functional dyspepsia

T2 - A randomized, controlled trial

AU - Yoon, Hyuk

AU - Lee, Dong Ho

AU - Lee, Yong Hyun

AU - Jeong, Ju Cheol

AU - Lee, Soo Teik

AU - Choi, Myung Gyu

AU - Jeon, Seong Woo

AU - Shim, Ki Nam

AU - Baik, Gwang Ho

AU - Kim, Jae Gyu

AU - Moon, Jeong Seop

AU - Sung, In Kyung

AU - Lee, Sang Kil

AU - Rhee, Poong Lyul

AU - Jung, Hwoon Yong

AU - Lee, Bong Eun

AU - Kim, Hyun Soo

AU - Kim, Sang Gyun

AU - Lee, Kee Myung

AU - Seong, Jae Kyu

AU - Jang, Jin Seok

AU - Park, Jong Jae

PY - 2018/9/1

Y1 - 2018/9/1

N2 - Background/Aims: To evaluate the efficacy and safety of a controlled release, once-daily formulation of mosapride (UI05MSP015CT) in patients with functional dyspepsia (FD). Methods: Patients with FD were randomly assigned (1:1) to receive either UI05MSP015CT (15 mg once a day, study group) or mosapride (5 mg three times a day, control group) and corresponding placebo for 4 weeks. The primary endpoint was a change in the gastrointestinal symptom score (GIS) evaluated at enrollment and after 4 weeks. Secondary endpoints were changes in the Nepean Dyspepsia Index-Korean version (NDI-K), rate of satisfactory symptom relief, and rate of adverse events. Results: A total of 138 patients were enrolled (female, 73.9%; mean age, 44.0±15.4 years). After excluding patients who violated the study protocol, 59 and 58 patients from the study and control groups, respectively, were included in the per-protocol analysis. No difference was observed in drug compliance between the control and study groups (97.07%±4.52% vs 96.85%±6.05%, p=0.870). Changes in GIS scores were –9.69±6.44 and –10.01±5.92 in the study and control groups. The mean difference in GIS change between groups was 0.33 (95% confidence interval, –1.75 to 2.41), demonstrating non-inferiority of UI-05MSP015CT (p=0.755). The rate of satisfactory symptom relief was not different between the study and control groups (39.0% vs 56.9%, p=0.053). No differences in change in NDI-K score (14.3 vs 16.9, p=0.263) or rates of adverse events (12.9% vs. 4.4%, p=0.062) were observed between the study and control groups. Conclusions: Once-daily mosapride is not inferior to conventional mosapride in efficacy and is safe in patients with FD.

AB - Background/Aims: To evaluate the efficacy and safety of a controlled release, once-daily formulation of mosapride (UI05MSP015CT) in patients with functional dyspepsia (FD). Methods: Patients with FD were randomly assigned (1:1) to receive either UI05MSP015CT (15 mg once a day, study group) or mosapride (5 mg three times a day, control group) and corresponding placebo for 4 weeks. The primary endpoint was a change in the gastrointestinal symptom score (GIS) evaluated at enrollment and after 4 weeks. Secondary endpoints were changes in the Nepean Dyspepsia Index-Korean version (NDI-K), rate of satisfactory symptom relief, and rate of adverse events. Results: A total of 138 patients were enrolled (female, 73.9%; mean age, 44.0±15.4 years). After excluding patients who violated the study protocol, 59 and 58 patients from the study and control groups, respectively, were included in the per-protocol analysis. No difference was observed in drug compliance between the control and study groups (97.07%±4.52% vs 96.85%±6.05%, p=0.870). Changes in GIS scores were –9.69±6.44 and –10.01±5.92 in the study and control groups. The mean difference in GIS change between groups was 0.33 (95% confidence interval, –1.75 to 2.41), demonstrating non-inferiority of UI-05MSP015CT (p=0.755). The rate of satisfactory symptom relief was not different between the study and control groups (39.0% vs 56.9%, p=0.053). No differences in change in NDI-K score (14.3 vs 16.9, p=0.263) or rates of adverse events (12.9% vs. 4.4%, p=0.062) were observed between the study and control groups. Conclusions: Once-daily mosapride is not inferior to conventional mosapride in efficacy and is safe in patients with FD.

KW - Compliance

KW - Efficacy

KW - Functional dyspepsia

KW - Mosapride

KW - Randomized clinical trial

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