Assessment of spasmodigestin tablets in treatment of cases of irritable stomach syndrome

Phase 3

Completed

• Conditions: Functional dyspepsia; Digestive System

• Registration Number: ISRCTN10744532
• Lead Sponsor: TCD MENA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-06-30
• Study Start: 2022-09-05
• Last Update Posted: 19 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 251

Inclusion Criteria

1. Aged =18 years and <60 years
2. Patients with functional dyspepsia who are defined as having upper abdominal pain or discomfort with one or more of the following symptoms: early satiety, postprandial fullness, bloating and nausea with the absence of GIT clinically significant findings.
3. Patients with acute onset of dyspeptic symptoms for less than 6 months and able to provide written informed consent.

Exclusion Criteria

1. Patients with chronic onset of dyspeptic symptoms for more than 6 months
2. Patients with inflammatory bowel disease (IBS), chronic calcular cholecystitis, lactose intolerance, psychiatric disorder requiring medication, major hepatic, renal or haematological diseases.
3. Patients with history of malignancy, laparoscopic or open abdominal surgery within the previous 6 months
4. Patients with history of the following diseases within the previous 6 months; peptic ulcer disease, GI bleeding, gastroesophageal reflux disease, intestinal stenosis or obstruction, infectious diarrhoea, or pancreatitis Also, patients with Unexplained iron deficiency anaemia, unintentional weight loss, dysphagia or persistent vomiting at time of study.
5. Patients with known allergy to the study drug. or taking concomitant medication acting on or influencing the gastrointestinal system (e.g., proton-pump inhibitors, H2 blockers, cholagogues, prokinetic agents, non-steroidal inti-inflammatory drugs, or theophylline).
6. Patients on antidepressant or anxiolytic treatment.
7. Pregnant or lactating female patients.
8. Female patients of childbearing age not using contraception.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Efficacy measured using dyspeptic symptoms (fullness, flatulance, early satiety, nausea, vomiting, epigastric pain) used an index for the global response over treatment period (10 days)<br> 2. Safety measured using serious adverse events using patient records (10 days duration)<br>