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Clinical Trials/CTRI/2013/12/004261
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

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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