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Clinical Trials/CTRI/2020/04/024624
CTRI/2020/04/024624
Recruiting
Phase 4

Prospective, observational, multi-centre, post marketing surveillance tomeasure the effectiveness of Omeprazole on patient reported outcomemeasures in acid peptic disease

Dr Reddys Laboratories Ltd0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: K279- Peptic ulcer, site unspecified, unspecified as acute or chronic, without hemorrhage or perforation

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: K279- Peptic ulcer, site unspecified, unspecified as acute or chronic, without hemorrhage or perforation
Sponsor
Dr Reddys Laboratories Ltd
Status
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
Observational

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Subjects must voluntarily give consent in writing to participate in the
  • •study by signing the Informed Consent Form (ICF)
  • •2\. Subjects of either sex diagnosed with acid peptic disease aged \>\=18
  • •years and \<\=65 years.
  • •3\. Subject who has been prescribed omeprazole therapy as routine
  • •clinical management as per Investigator discretion.

Exclusion Criteria

  • •1\. Hyper\-sensitivity to any Proton pump inhibitor including omeprazole
  • •in the past.
  • •2\. Participated in an investigational drug or investigational device study
  • •within 30 days prior to the start of the study
  • •3\. Prior treatment for acid peptic disease histamine\-2 receptor
  • •antagonists or over the counter antacids during the week immediately
  • •before the study
  • •4\. Any medical condition according to investigator which may interfere
  • •with the treatment. Makes patient illegible for participation in study.
  • •5\. Planned surgical procedure during the duration of the study.

Outcomes

Primary Outcomes

Not specified

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