CLINICAL TRIALS PROFILE FOR ACOTIAMIDE
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Clinical Trials for Acotiamide
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT00764374 ↗ | A Long-term, Open-label, Uncontrolled Trial of YM443 (Z-338) in Patients With Functional Dyspepsia | Completed | Astellas Pharma Inc | Phase 3 | To examine the safety and efficacy of Z-338 (YM443) after long-term administration in patients with functional dyspepsia, and also to examine the pattern of long-term administration. |
| NCT00850746 ↗ | A Study to Evaluate the Effect of Repeat Oral Doses of YM443 on Cardiac Repolarization in Healthy Adults | Completed | Astellas Pharma Inc | Phase 1 | This study evaluates whether YM443 causes any changes in the electrocardiogram of healthy adults. |
| NCT01973790 ↗ | Phase III, Long-term, Open-label Safety Study of Z-338 | Completed | Zeria Pharmaceutical | Phase 3 | The primary objective of this study is to evaluate the long-term safety of 100 mg Z-338 TID in European subjects with FD. |
| NCT03402984 ↗ | Effect of Acotiamide on Gastric Motility and Satiation in Healthy Volunteers | Completed | Universitaire Ziekenhuizen Leuven | N/A | Introduction. Functional dyspepsia (FD) is a common chronic gastrointestinal disorder with a high socio-economic impact. Acotiamide, a new prokinetic agent, was shown to be efficacious in the treatment of FD, especially in the postprandial distress syndrome subgroup. To date, the exact mechanism of action of acotiamide is incompletely elucidated. The aim of this study was to examine the effect of acotiamide on gastric motility, gastric emptying rate and gastrointestinal symptom perception in healthy participants in a randomized, placebo-controlled, cross-over study design. Participants were treated with acotiamide (100 mg t.i.d.) and placebo for 3 weeks, separated by a one-week wash-out period. At the end of each treatment period, gastric emptying and motility were assessed on two consecutive study days. During gastric motility assessment, epigastric symptom scores were collected at multiple time points. |
| NCT04526119 ↗ | A Phase III Trial of Z-338 in Paediatric Patients With Functional Dyspepsia | Recruiting | Zeria Pharmaceutical | Phase 3 | The purpose of this study is to evaluate pharmacokinetics, efficacy and safety of Z-338 of pediatric patients with functional dyspepsia (FD). In Part 1, the pharmacokinetics and safety of single oral dose of Z-338 100 mg are evaluated. In Part 2, the efficacy and safety of Z-338 100 mg orally 3 times daily before meals are evaluated. Part 2 is comprised by the double-blind phase and the open-label phase. In the double-blind phase, subjects will take Z-338 or placebo for 28 days. In the open-label phase, all subjects will take Z-338 for 28 days. |
| NCT04697641 ↗ | Helicobacter Pylori Eradication in Functional Dyspepsia | Completed | Sir Ganga Ram Hospital | N/A | This study is designed to study benefit of eradicating Helicobacter Pylori in patients with functional dyspepsia as compared to symptomatic treatment only. Helicobacter pylori positive patients with Functional Dyspepsia will be divided into two study groups, one will receive Helicobacter pylori eradication therapy and other will receive symptomatic treatment. Symptom relief based on Likert scale will be compared in both groups. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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