Dear Dr. {{$doctorName}},
Subject: In-Practice Usage and Performance (IPUP) Study of Montek FX
Study code: IPUP/Montek FX /ENT/Pharma care/April 2023
Allergic rhinitis is considered the most significant atopic condition which affects quality of life. Along with intranasal
corticosteroid, Leukotriene receptor antagonist like Montelukast, mast cell stabilizer and modern antihistamines are pillars of
pharmacotherapy of allergic rhinitis. Fexofenadine shows no somnolence, no effect on psychomotor and cognitive function no
impairment of driving performance.
Montek FX (fixed dose combination of Montelukast Sodium IP 10 mg and Fexofenadine Hydrochloride IP 120 mg) tablets 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 ‘Montek FX’ in allergic rhinitis in adult patients.
We invite you to participate in this study. All you need to do is to report on a standard form your experience with ‘Montek FX’ 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 ‘Montek FX’ 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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