A clinical Trial to study the efficacy, safety and tolerability of Levosulpiride 25mg + alprazolam 0.25mg tablets vs. Domperidone 10mg tablets in patient with functional dyspepsia.
- Conditions
- Health Condition 1: K30- Functional dyspepsiaHealth Condition 2: null- In patient with functional dyspepsia.
- Registration Number
- CTRI/2010/091/006116
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Patients having a minimum of 1-month history of dyspepsia.
Heartburn on 3 out of the last 7 days prior to screening or randomization.
Written informed consent by patient participating in the trail.
Males or females, <18 or >75 years of age.
Patients showing alarm features (unintentional weight loss, persistent vomiting, dysphagia, haematemesis, melaena, fever, jaundice, or anaemia), irritable bowel syndrome or serious concomitant disease.
Patients with a history of gastrointestinal disease, recent gastrointestinal surgery i.e. within 30 days.
Patients who had been treated with NSAIDs, ASA (>325 mg/day), H2-RAs, PPIs, prokinetic agents, misoprostol or sucralfate 15 days prior to enrollment.
Pregnant, possibly pregnant, or lactating females.
Participation in clinical trial with an investigation drug within 30 days proceeding day one of this study.
Any condition that in the opinion of the investigator, does not justify the patient?s inclusion in the study.
History of hypersensitivity to the study drug or similar class of drug.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pper abdominal pain,Belching, Nausea (with or without vomiting), Bloating, Early satiety (the sensation of fullness after a very small amount of food).Timepoint: 1st week, 2nd week, 3rd week, 4th week
- Secondary Outcome Measures
Name Time Method Overall response of clinical cure & overall global assessment.Timepoint: 4th week;Safety and tolerability of the test and reference product will be assessed depending on the improvement of following safety parameters: constipation, skin rash, dizziness, difficulty in breathing or speaking, fainting, irregular heartbeat, loss of balance or muscle control, swelling of face, hands or legs.Timepoint: 2nd week, 3rd week,4th week