Date: {{$ActivityAssignDate}}

To,


Mr. Sunil Jajoo


VP & Cluster Head, Dermatology

Sun Pharmaceutical Industries Ltd.


Dear {{$doctorName}},


Subject: {{$ActivityName}}


In response to your letter dated ____________, I agree to participate in the study as outlined by you. I understand that:


  • You will provide me with a copy of the study plan, ___ data collection form (DCF)

  • The patients’ identity will not be disclosed in the DCF

  • You will provide the assistance of a personnel to verify the information in the DCF in the given format


My personal details are given below for accuracy of your records.
Name: {{$doctorName}}
Qualifications:
Speciality:
Postal Address:
PIN:
Clinic or Hospital Telephone Number:
Residence Telephone Number:

Yours sincerely,

[Signature & Stamp]
{{$doctorName}}

Date: {{$ActivityAssignDate}}

Drug utilization pattern in Chronic Urticaria


Doctor:
Address:
Contact: Tel. (Res) Tel. (Off.) Fax: E-Mail:
Monitor:
Contact: Tel. (Res) Tel. (Off.) Fax: E-Mail:

Sun Pharmaceutical Industries Limited


Sun House, 201/B1, Western Express Highway,

Goregaon (East), Mumbai,

Maharashtra (India) – 400 063


This document is the property of Sun Pharmaceutical Industries Limited and is confidential. Therefore, it may not be photocopied, either in part or in full, or shown to any person not directly associated either with the trial, or with the concerned ethics committee, or with the concerned regulatory authority.


Background and Introduction


Chronic urticaria is one of the most frequent skin disorders​1. It is one of the most prevalent dermatology diseases in India and has a profound effect on quality of life and causes immense distress to the patients, necessitating effective treatment. Various clinical studies and research have been done in last few years on the treatment regimens, usage of anti-histamines in urticaria, in which up dosing one of the latest & revolutionary advancement is observed across the globe.


Guideline recommends use of second generation H1 antihistamines as the first line treatment and the dose can be increase to meet the expected results. There are numerous studies showing the benefit of a higher dosage of antihistamines in individual patients. These studies suggest that the majority of patients with urticaria not responding to single dose will profit from up-dosing of antihistamines​2.


This RWE study has been undertaken to understand the drug utilization pattern in treatment of patients with chronic urticaria in real life scenario.


Study objective


To assess the drug utilization pattern in treatment of patients with chronic urticaria.


Discussion of study design


One time cross-sectional study

Date:{{$ActivityAssignDate}}

Methodology


Study design: Cross-sectional, observational, multicenter study. No active intervention will be done for the purpose of this study.


Data will be collected from various hospitals, clinics or institutions all over India. Data will be recorded in the Data Collection Form from medical records of patients who have been following up with their treating physician. Each investigator has to share data of 10 patients.

Administrative matters


DCFs and Stationary Items


The experience of expected effectiveness and adverse events will be recorded on the DCF supplied for the sake of uniformity, ease of data compilation, and analysis. Before collecting the DCF, the personnel will be allowed to verify the entries to ensure their accuracy. The identity of patients will not be disclosed, and the original records will remain with the doctor.


DCF will be collected by the personnel and forwarded to the Marketing department for data entry and analysis.

Investigator’s Consent/Agreement:


I have read the plan of the study, understood its purpose and methodology, and agree to carry it out according to the plan.

Signature of Doctor and Date


References:


  1. Acta Derm Venereol. 2013 Mar 27;93(2):168-74.
  2. Allergy. 2014 Jul;69(7):868-87.