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Clinical Trials/CTRI/2013/09/003944
CTRI/2013/09/003944
Active, not recruiting
Phase 4

A prospective, comparative, controlled, randomized, open label, parallel, 3-arm study to evaluate and compare the efficacy and safety of Troxipide (100 mg) and Rabeprazole (20 mg) alone and in combination in patients suffering from acid peptic disorders - TRO/RAB/11/2011

Government Medical College Hospital0 sites100 target enrollmentTBD
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ConditionsHealth Condition 1: null- Acid Peptic Disorder

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: null- Acid Peptic Disorder
Sponsor
Government Medical College Hospital
Enrollment
100
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

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

  • •Patients with symptoms of dyspepsia having Glasgow Dyspepsia Severity Score \> 2
  • •Patients undergoing upper gastro intestinal endoscopy having signs of any of acid peptic disorder
  • •Subjects who provide a written informed consent

Exclusion Criteria

  • •History of any diagnosed gastrointestinal disorder other than acid peptic disorder
  • •History of any previous abdominal / gastrointestinal surgery
  • •History of treatment with drugs capable of interfering with digestive mucosal integrity, acid secretion or gastrointestinal motility, (including H2 receptor antagonists, NSAIDs, muscarinic antagonists, cytoprotective agents) within the previous 7 daysys
  • •Requires concomitant medication which precludes the evaluation of study medications
  • •Patients with signs suggestive of any acute complication of acid peptic disorder
  • •Any contraindication for endoscopy examination
  • •Evidence of gastric malignancy, pyloric obstruction, or oesophageal stricture on endoscopy
  • •Patients who are drug or alcohol abusers
  • •Patients with known hypersensitivity to any of the ingredients of the test / Comparator formulation
  • •Patients with impairment of renal or hepatic function, severe cardiac disease, any respiratory disease or haematological abnormality

Outcomes

Primary Outcomes

Not specified

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