A Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of DA-9701 (Motilitone) in Patients With Constipation-type Irritable Bowel Syndrome and Functional Dyspepsia Overlap: A Pilot Study

Lee, Ju Yup; Kim, Na Young; Yoon, Hyuk; Shin, Cheol Min; Park, Young Soo; Lee, Dong Hoon

doi:10.5056/jnm20236

Cited by 4 publications

(3 citation statements)

References 47 publications

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“…Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder that causes chronic diarrhea or constipation, stomach bloating, and abdominal cramping by affecting the gastrointestinal motility and immunity ( Ford et al., 2018 ; Lee et al., 2022 ; Raskov et al., 2016 ). However, the mechanism of IBS-related pathophysiology remains poorly understood.…”

Section: Trp Nutrition In Diseases Preventionmentioning

confidence: 99%

Intestinal tryptophan metabolism in disease prevention and swine production

Hu,

Feng,

Jiang

et al. 2023

Animal Nutrition

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Section: Trp Nutrition In Diseases Preventionmentioning

confidence: 99%

Intestinal tryptophan metabolism in disease prevention and swine production

Hu,

Feng,

Jiang

et al. 2023

Animal Nutrition

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“… 8 , 9 , 10 Therefore, β 3 ‐adrenergic receptor activation has been suggested as a potential novel target for treating pain and modulating gastrointestinal motility in patients with IBS. 11 , 12 Evidence for the therapeutic potential of β 3 ‐adrenergic receptor activation in the treatment of IBS has been shown in preclinical studies, including ex vivo data showing β 3 ‐adrenergic receptor agonist inhibition of cholinergic contractions in isolated human colon, which was fully reversed in the presence of a β 3 ‐adrenergic receptor antagonist. 10 A pilot clinical trial demonstrated improved IBS‐related pain among women with IBS receiving a β 3 ‐adrenergic receptor agonist.…”

Section: Introductionmentioning

confidence: 99%

“… 10 A pilot clinical trial demonstrated improved IBS‐related pain among women with IBS receiving a β 3 ‐adrenergic receptor agonist. 12 …”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of vibegron for the treatment of irritable bowel syndrome in women: Results of a randomized, double‐blind, placebo‐controlled phase 2 trial

Lacy

King

Shortino

et al. 2022

Neurogastroenterology Motil

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Background Preclinical and clinical studies suggest that β3‐adrenergic receptor activation may be a novel target for treating abdominal pain and gastrointestinal motility dysfunction in patients with irritable bowel syndrome (IBS). This proof‐of‐concept study evaluated the efficacy and safety of the β3‐adrenergic agonist vibegron in treating IBS‐related pain. Methods Adult women with predominant‐diarrhea IBS (IBS‐D) or with mixed diarrhea/constipation (IBS‐M), diagnosed using Rome IV criteria, were randomized 1:1 to receive once‐daily vibegron 75 mg or placebo for 12 weeks. The primary endpoint was the percentage of patients with IBS‐D considered abdominal pain intensity (API) weekly responders, defined as ≥30% reduction from baseline at week 12 in mean weekly worst abdominal pain over 24 hours using the API score. Patients completed a pain diary at baseline and at weeks 2, 4, 8, and 12. Safety was assessed by adverse events (AEs) in the overall IBS population. Key Results Of the 222 patients with IBS randomized (vibegron, N = 111; placebo, N = 111), 85% completed the trial. There was no significant difference in the percentage of patients with IBS‐D (vibegron, N = 66; placebo, N = 63) considered API weekly responders with vibegron vs. placebo (p = 0.8222) after 12 weeks. The incidence of AEs was comparable between treatment groups (33.3% each), with equal rates of worsening IBS symptoms (2.7% each). Conclusions and Inferences In women with IBS‐D, vibegron was not associated with significant improvement in the percentage of API weekly responders. Vibegron was generally safe and well tolerated and, in particular, did not worsen IBS symptoms vs. placebo.

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