| CTRI Number |
CTRI/2017/10/010105 [Registered on: 16/10/2017] Trial Registered Prospectively |
| Last Modified On: |
18/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative Clinical Study to Evaluate the effectiveness of DEXAMETHASONE-AGIO Injection in the treatment of severe or incapacitating allergic conditions of skin and respiratory tract |
Scientific Title of Study
Modification(s)
|
A Prospective, Randomized Double Blind, Active Controlled, parallel Comparative Clinical Study to Evaluate the Efficacy and Safety of DEXAMETHASONE-AGIO (Dexamethasone sodium phosphate 4mg/ml) Injection of Agio Pharmaceuticals Ltd. Mumbai, India with DEXAMETHASONE (Dexamethasone sodium phosphate 4mg/ml) Injection of the company KRKA Slovenia in the treatment of severe or incapacitating allergic conditions of skin and respiratory tract |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/CR/APPL/0627/76 version 01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr KN Mohan Rao |
| Designation |
HOD and Professor |
| Affiliation |
Rajarajeswari Medical College & Hospital |
| Address |
Department of TBCD Pulmonary Medicine # 202, Kambipura, Mysore Road
Bangalore
KARNATAKA
560074
India |
| Phone |
9845270973 |
| Fax |
|
| Email |
kotnur.rao@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish s |
| Designation |
Director operations |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16 & 18 ICBio Tower,
Yelahanka Main Road,
Chikkabettahalli, Vidyaranyapura
Bangalore
KARNATAKA
560 097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish s |
| Designation |
Director operations |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16 & 18 ICBio Tower,
Yelahanka Main Road,
Chikkabettahalli, Vidyaranyapura
Bangalore
KARNATAKA
560 097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| Agio Pharmaceuticals Ltd. A-38 Nandjyot Industrial Estate,Kurla
Andheri Road,
Mumbai 400072, India
|
|
|
Primary Sponsor
|
| Name |
Agio Pharmaceuticals Ltd |
| Address |
A-38 Nandjyot
Industrial Estate,
Kurla Andheri Road, Mumbai 400072, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 KN Mohan Rao |
Rajarajeswari Medical College & Hospital |
Department of TBCD
Pulmonary Medicine
# 202, Kambipura, Mysore Road,
Bangalore
KARNATAKA |
9845270973
kotnur.rao@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajarajeswari Medical College & Hospital Instiutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Treatment of severe or incapacitating allergic conditions of skin and respiratory tract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DEXAMETHASONE (Dexamethasone sodium phosphate,4mg/ml) |
Day 1 :- 8 mg IV/IM Once a day
Day 2 :- 4 mg IV/IM Twice a day
Day 3 :- 2 mg IV/IM Twice a day
Day 4 :- 2 mg IV/IM Once a day
Day 5 :- 2 mg IV/IM once a day
|
| Intervention |
DEXAMETHASONE-AGIO solution for injection (intravenous/intramuscular injection) |
Day 1 :- 8 mg IV/IM Once a day
Day 2 :- 4 mg IV/IM Twice a day
Day 3 :- 2 mg IV/IM Twice a day
Day 4 :- 2 mg IV/IM Once a day
Day 5 :- 2 mg IV/IM once a day
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Willing to provide written informed consent for participation in the study and adhere to the protocol requirements.
2. Patients with severe or incapacitating allergic conditions:
Bronchial asthma
Acute allergic bronchitis
Contact dermatitis
Atopic dermatitis
Seasonal or perennial allergic rhinitis
Drug hypersensitivity reactions
Urticarial transfusion reactions
Acute noninfectious laryngeal edema
|
|
| ExclusionCriteria |
| Details |
1. Patients who are not willing to give written informed consent
2. A medical history of significant hypersensitivity or allergic reaction to dexamethasone or any corticosteroids.
3. Current chronic use of steroids
4. patients with smoking habit
5. Patients being treated with antibiotics
6. Participation in any clinical trials prior to 12 months
7. Current treatment with immune-suppressants (eg, cyclosporine or methotrexate)
8. Current treatment with phototherapy (UVA, UVB, PUVA and lasers)
9. Use of systemic corticosteroids in the visit to include Topical treatments at the site of lesions in the 15 days preceding the survey
10. Presence of secondary infections at the site of treatment, diagnosed clinically;
11.Presence of other eczematous diseases, such as nummular eczema, neurodermatitis, seborrheic dermatitis, psoriasis, scabies, and Buckleys syndrome
12. Pregnant or lactating women
13. Chronic alcoholism
14. Any finding of clinical observation (clinical history or physical examination) that is interpreted by the physician investigator as a risk to the patients participation in the study.
15. History of diabetic mellitus, thyroid dysfunction
16. Current or suspected diagnosis of viral, fungal, non infectious causes of pulmonary infiltrates, lung cancer, cystic fibrosis, tuberculosis,
17. History of muscle weakness
18. Severely immunocompromised patients
19. Bacteremia and systemic fungal infections, glaucoma, hypersensitivity to any of the products components, Cushing’s syndrome, gastric and duodenal ulcers, certain viral infections, i.e. varicella, herpes genita previous or current exposure to chicken pox, varicella virus and measles or have taken vaccination for the same.
20. Patients with positive serology laboratory values.
21. History of intubations for asthma or co morbidities (Chronic Lung Disease (CLD), Congenital Heart Defects (CHD), or neurologic disorders)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Patients with skin allergies
1. Percentage change in the total score of signs and symptoms
Constitute secondary signals of efficacy including excoriation,oozing,crusting and lichenification.
Patients with respiratory allergies
1. The time from study entry to respiratory distress with 5 days of treatment
2.wheezing and Retraction of muscles along with Respiratory rate and oxygen saturation score of 0 to 3
3. The duration of oxygen therapy |
Baseline to End of Treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Arm 1 (Patients with skin allergies):Adverse events
Arm 2 (Patients with respiratory allergies):Adverse events
|
Baseline to End of treatment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/10/2017 |
| Date of Study Completion (India) |
18/09/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="17" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
A prospective randomised Double blind active controlled parallel comparative clinical study to Evaluate the efficacy and safety of Dexamethasone Agio injection of AGIO Pharmaceuticals Ltd. Mumbai with Dexamethason Injection of KRKA Slovenia in the treatment of severe or incapcitating allergic conditions of skin and respiratory tract
Duration Of the study for 17 days
Total Number of Subjects 60
|