| CTRI Number |
CTRI/2018/11/016258 [Registered on: 02/11/2018] Trial Registered Prospectively |
| Last Modified On: |
07/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case study |
| Study Design |
Other |
|
Public Title of Study
|
Reddish skin rash caused by pain medication Etoricoxib |
|
Scientific Title of Study
|
A possible case of Etoricoxib- Induced Fixed Drug Eruption |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Apoorva |
| Designation |
PostGraduate in Pharmacology |
| Affiliation |
Kempegowda Institute of Medical Sciences |
| Address |
Nandi crystals Apartment
BTM layout stage 2
Bangalore
Bangalore
KARNATAKA
560076
India |
| Phone |
|
| Fax |
|
| Email |
apoorvaprabhu89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KGirish |
| Designation |
Professor and HOD of Pharmacology |
| Affiliation |
Kempegowda Institute of medical Sciences |
| Address |
Kempegowda Institute of Medical Sciences
BSK STAGE 2
Bangalore
Bangalore
KARNATAKA
560070
India |
| Phone |
|
| Fax |
|
| Email |
drgirish_k@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apoorva |
| Designation |
PostGraduate in Pharmacology |
| Affiliation |
Kempegowda Institute of medical Sciences |
| Address |
Nandi crystals Apartment
BTM layout stage 2
Bangalore
Bangalore
KARNATAKA
560076
India |
| Phone |
|
| Fax |
|
| Email |
apoorvaprabhu89@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Apoorva |
| Address |
Kempegowda Institute of Medical sciences and Research Hospital |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Apoorva |
Kempegowda Institute of Medical Sciences and Research Hospital,Bangalore |
Dermatology OPD,B Block,first floor,room no-12
Bangalore
KARNATAKA |
9902333326
apoorvaprabhu89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L989||Disorder of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Etoricoxib |
Etoricoxib compared to other NSAIDs of same group like Celecoxib |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
51.00 Year(s) |
| Gender |
Male |
| Details |
50 yr old male patient with complain of fixed drug eruption due to tab Etoricoxib |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Adverse drug reaction due to etoricoxib |
within 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="1"
Sample Size from India="1"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/11/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="7" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1.Brahimi N, Routier E, Raison-Peyron, Tronquoy AF, Pouget-
Jasson, Amarger S, et al. A three-year-analysis of fixed drug
eruptions in hospital settings in France. Eur J Dermatol.
2010;20:461---4.
2. Lee AY. Fixed drug eruptions. Incidence, recognition, and avoidance.
Am J Clin Dermatol. 2000;1:277---85. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A Case of Fixed Drug Eruption due to Etoricoxib in a 50yr old male patient Dr Apoorva, Dr Girish K, Dr Namritha C Manjunath Kempegowda Institute of Medical Sciences & Research Center (KIMS& RC), Bangalore,Karnataka,India BACKGROUND/OBJECTIVES Fixed drug eruption is a commonly reported adverse drug reaction.Non-steroidal anti inflammatory drugs(NSAIDs) in particular nimesulide are the most frequent agents, followed by antibiotics and anticonvulsants. Etoricoxib is a selective cyclo-oxygenase isoenzyme 2 inhibitor which has rarely been a cause of Fixed Drug Eruption. We present a case of fixed drug eruption due to Etoricoxib in a 50yr old male patient with previous allergic history to NSAIDs. CASE REPORT/METHODS: 50yr old male patient was prescribed Tab Etoricoxib by local doctor for low backpain.Next day the patient noticed reddish raised lesion, with pain and itching which was initially seen on the neck and gradually progressed to both the limbs and trunk. Subsequently, the patient was admitted to KIMS Hospital. A diagnosis of Fixed Drug Eruption due to Etoricoxib was made after ruling out other causes. Treatment was initiated with Intravenous and topical Steroids and IV Ceftriaxone was given for seconday infection. The lesions improved significantly with the above management and the patient was discharged after a week of admission. RESULTS: The reaction was assessed to be“probable†as per WHO-UMC and Naranjo causality scale, “moderateâ€on Hartwig’s scale and “Probably preventable†according to Schumock and Thornton criteria. CONCLUSION: Reactions such as Fixed Drug Eruptions can be caused by drugs like Etoricoxib. |