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Clinical Trials/CTRI/2017/11/010421
CTRI/2017/11/010421
Recruiting
未知

Real world, Non-interventional, Observational Study of acotiamide hydrochloride hydrate in functional dyspepsia

Dr Reddys Laboratories Limited0 sites0 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Dr Reddys Laboratories Limited
Status
Recruiting
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
Observational

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\.Patients clinically diagnosed with functional dyspepsia where physician has taken decision to prescribe acotiamide hydrochloride hydrate.
  • 2\.Patients with Functional Dyspepsia as defined by Rome III criteria
  • Diagnostic criteria Must include: One or more of the following:
  • a. Bothersome postprandial fullness
  • b. Early satiation
  • c. Epigastric pain
  • d. Epigastric burning
  • and No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms
  • Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis

Exclusion Criteria

  • 1\.Patients with a known or suspected hypersensitivity to acotiamide or to any ingredients of the formulation
  • 2\.Patients on cholinergic drugs as part of therapy
  • 3\.Patients on prokinetics as a part of therapy
  • 4\.Structural lesion evident in endoscopy
  • 5\.Coexisting Irritable bowel syndrome
  • 6\.Heartburn in past 12 weeks
  • 7\.Pregnant and lactating women

Outcomes

Primary Outcomes

Not specified

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