CTRI/2017/11/010421
Recruiting
未知
Real world, Non-interventional, Observational Study of acotiamide hydrochloride hydrate in functional dyspepsia
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.
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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