Dear Dr. {{$doctorName}},
Subject: In-Practice Usage and Performance (IPUP) Study of Raciper D
Study code: IPUP/Raciper D /Phy/Pharma care/April 2023
Acid Peptic Diseases (APDs) are multifactorial disorders, including number of conditions
like gastro-esophageal reflux disease (GERD), gastritis, dyspepsia, gastric ulcer, duodenal
ulcer, and esophageal ulcer. APD result from distinctive but overlapping pathogenic
mechanisms that typically involve acid effects on diminished mucosal defense. Gastro
esophageal reflux disease (GERD) and peptic ulcer disease (PUD) are two most common
and well defined disease due to damage produced by acid. Proton pump inhibitors (PPIs)
are one of the most commonly prescribed medications in the treatment of acid-peptic
diseases. Prokinetics increase lower esophageal sphincter pressure, enhance esophageal
peristalsis, and augment gastric emptying. Addition of prokinetics to PPI therapy may
improve the symptoms of GERD.
Raciper D (Esomeprazole 40 mg and Domperidone 30 mg) capsules are marketed by the
‘Pharma care’ team of Sun Pharmaceutical Industries Ltd.
Although every product is marketed only after regulatory approval, it is important to know how it performs in day-to-day practice of individual medical practitioners. For this purpose, we have planned to conduct a cross sectional study to assess the real-life performance of ‘Raciper D’ in Acid Peptic Diseases.
We invite you to participate in this study. All you need to do is to report on a standard form your experience with ‘Raciper D’ in these consecutive patient’s (to avoid any bias) in whom you prescribe this product in the normal course of your practice. Thus, this is not an experimental study because the product will be prescribed and purchased as you and your patients normally do.
If you agree to participate, you will need to copy the relevant information from the
suggested number of patient’s case papers, and investigational reports, if any (which we
call source documents), on to the standard case report forms (which we call CRF).
CRF has to be verified to ensure that the CRF signed by you are free from errors or omissions. Let us assure you that the CRF will not contain the patients’ names, so as to ensure confidentiality.
If any serious adverse events (AE) occur during ‘Raciper D’ therapy, you will be expected
to report them to the monitor or to me immediately on the AE reporting form.
As you will be spending some extra time to keep, copy and verify these patients records, we offer to pay you by cheque a professional fee of Rs. {{$contractAmount}}/- .
We trust you and we are partners in promoting safe and effective drug therapy. In that spirit,
we hope you will consent to participate in this study. If you do, please sign and return the
enclosed reply along with your visiting card for accuracy of records.
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