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A Double-blind Placebo Controlled Study of Acotiamide Hydrochloride for Efficacy on Gastrointestinal Motility of Patients with Functional Dyspepsia

A Double-blind Placebo Controlled Study of Acotiamide Hydrochloride for Efficacy on Gastrointestinal Motility of Patients with Functional Dyspepsia - Efficacy of Acotiamide Hydrochloride on Gastrointestinal Motility of Patients with Functional Dyspepsia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013544
Enrollment
50
Registered
2014-03-28
Start date
2014-03-28
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Dyspepsia

Interventions

Acotiamide Hydrochloride Placebo

Sponsors

Hyogo College of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Outpatients who are at least 20 years of age. 2. Patients with at least one of the following symptoms. -Bothersome postprandial fullness after eating a normal amount of food that occurs at least twice a week. -Unable to finish a normal amount of food due to early satiation at least twice a week. 3. Patients with symptom onset at least 6 months before the visit who meet the above criteria over the last 3 months. 4. Patients who undergo upper gastrointestinal endoscopy within 1 year from the visit and are found to have no organic diseases (malignant tumors, peptic ulcer, esophagitis, etc.) that are likely to cause upper abdominal symptoms.

Exclusion criteria

Exclusion criteria: 1. Patients with conditions that are likely to cause upper abdominal symptoms such as malignant tumors, peptic ulcers and systemic diseases (neurological diseases including Parkinson's disease, metabolic diseases including diabetes, etc). 2. Patients with known causes of upper abdominal symptoms including excessive drinking, overeating, taking NSAIDs, and sever stress. 3. Patients with predominant GERD 4. Patients with predominant irritable bowel syndrome (IBS) 5. Patients with a history of surgery of the upper gastrointestinal tract including the stomach and esophagus.

Design outcomes

Primary

MeasureTime frame
Gastric emptying (T1/2) and accommodation (%) by gastric scintigraphy

Countries

Japan

Contacts

Public ContactTadayuki Oshima

Hyogo College of Medicine Division of Gastroenterology, Department of Internal Medicine

t-oshima@hyo-med.ac.jp+81-798-45-6662

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026