Phase III Study to Compare the Efficacy and Safety of Acotiamide 100 mg Tablets with Placebo in Patients with Functional Dyspepsia.

Phase 3

• Conditions: Health Condition 1: null- Functional Dyspepsia

• Registration Number: CTRI/2015/02/005557
• Lead Sponsor: PIN Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 222

Inclusion Criteria

1.Diagnosed as Functional Dyspepsia â?? Postprandial Distress Syndrome as defined by the Rome III classification

2.Patients with at least one of the following two symptoms for at least 6 months

•Postprandial fullness

•Early satiety

OR

Patients with two or more of the following symptoms at a moderate or severe level within the previous 3 months (At least one symptom of postprandial fullness, upper abdominal bloating or early satiety should be included):

•Upper abdominal pain

•Upper abdominal discomfort

•Postprandial fullness

•Upper abdominal bloating

•Early satiety

•Nausea

•Vomiting

•Excessive belching

3.Patients with coexisting epigastric pain syndrome symptoms (epigastric pain, epigastric burning) may be included, but the symptom causing the most distress at the time of screening should be one of the following meal-related symptoms: postprandial fullness, upper abdominal bloating or early satiation

Exclusion Criteria

1.Subjects with any structural disease of esophagus, stomach or duodenum that is likely to explain the symptoms.

2.History of heartburn within 12 weeks prior to screening and during the 7 days of baseline period

3.Any gastrointestinal co-morbidity like irritable bowel syndrome which may confound the evaluation of symptoms

4.Presence of any severe or malignant disease

5.Patients with renal or hepatic dysfunction

Study & Design

• Study Type: Interventional
• Study Design: Not specified