Health Condition 1: null- Functional Dyspepsia
Conditions
Interventions
Intervention1: Acotiamide Hydrochloride Hydrate: Acotiamide Hydrochloride Hydrate 100 mg tablets of Lupin Ltd. Patients will receive either Acotiamide 100 mg tablets or placebo tablets three times dai
Sponsors
LUPIN Limited
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Treatment Efficacy (OTE) at the end of 4 weeks treatment periodâ?? Global assessment will be done by patients using a questionnaire. This will be scored on a seven-point Likert scale ranging from â??extremely improved, improved, slightly improved, not changed, slightly aggravated, aggravated and extremely aggravatedâ?? as compared with the baseline periodTimepoint: NIL | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Elimination rate (score 0) of each individual symptom at the end of 4 weeks treatment period and follow up period â?¢Elimination rate (score 0) of all three major symptoms i.e. Postprandial fullness, Upper abdominal bloating, and Early satiation at the end of 4 weeks treatment period and follow up periodTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Chirag Shah
Lupin Limited
Outcome results
None listed