Functional dyspepsia Digestive System
Conditions
Interventions
This was a prospective, open label, interventional, phase IV, multi-centre study. Patients were administrated Spasmodigestin® oral tablets according to the approved summary of product characteristics
screening visit (day -7), baseline visit (day 0) and a follow-up visit (day 10).
Patient were given diaries to record dyspeptic symptoms, intensity of dyspeptic symptoms and Nepean Dys
Sponsors
TCD MENA
Pharco pharmaceutical company
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) 2. Safety measured using serious adverse events using patient records (10 days duration) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient's self-rating of the intensity of each dyspeptic symptoms using a four-point Likert scale (10 days duration) 2. Sum score of differences between baseline and improvement of health-related quality of life using short form Nepean dyspepsia index over 10 days 3. Number of responders (50% decrease of dyspeptic symptoms) measured using the patient’s self-rating of intensity four-point Likert scale and Short Form Nepean Dyspepsia Index (SF-NDI) at baseline and at 10 days after treatment 4. Total number of pills consumed measured using patients self- administrate diaries during 10 days. 5. Number of patients with on-treatment adverse events measured by asking the subject after 10 days of treatment. 6. The number of patients discontinued due to adverse events measured using patients self- administrate diaries and by asking the subject at 10 days of treatment 7. The main reasons for treatment failure and delayed response measured using patients self-rating of intensity four-point Likert scale and Short Form Nepean Dyspepsia Index (SF-NDI) at baseline and at 10 days after treatment. | — |
Countries
Egypt
Contacts
Public ContactWalaa Nasr Elghitany
Outcome results
None listed