CTRI/2013/12/004261
Completed
Phase 4
Randomized controlled study of the effectiveness of lafutidine versus pantoprazole for uninvestigated dyspepsia.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Institute of Postgraduate Medical Education Research
- Enrollment
- 122
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Symptoms of dyspepsia for at least 1 months
- •Moderate\-to severe symptoms (score \>\= 4 on the7\-point Likert scale for each symptom in global overall symptoms scale).
Exclusion Criteria
- •Patient with alarm features (unintentional weight loss, persistent vomiting, dysphagia, hemetemesis, melena, fever, jaundice, or anemia),
- •History of serious gastrointestinal disease (including peptic ulcers, malignancy, esophageal dysmotility, a previous endoscopic or radiological diagnosis of GERD and Barrettâ??s esophagus)
- •Patients with angina pectoris.
- •Patients who show any of the following values at the baseline laboratory tests: Hemoglobin \< 9\.5 g/dL, total leukocyte count \< 3,000/mm3, platelet count \< 75,000/mm3, AST and ALT \>\= 100 IU/L, Creatinine \>\= 1\.5 mg/dl
- •Treatment with non\-steroidal anti\-inflammatory drugs (NSAIDs), H2\-blockers, proton pump inhibitors, prokinetic agents, misoprostol or sucralfate 15 days prior to enrollment
- •Concomitant serious disease of vital organs such as the liver, kidney, heart or lungs.
- •Women who are pregnant, lactating, or not willing to use adequate methods of contraception.
- •History of substance abuse.
- •Any other condition which can lead the investigators to consider the subject unsuitable for selection.
Outcomes
Primary Outcomes
Not specified
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