Clinical trial to observe the safety and effectiveness of acotiamide in patients with functional dyspepsia
- Conditions
- Health Condition 1: null- Patients with functional dyspepsia diagnosed by rome 3 criteria
- Registration Number
- CTRI/2017/11/010421
- Lead Sponsor
- Dr Reddys Laboratories Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method