| CTRI Number |
CTRI/2021/04/032664 [Registered on: 08/04/2021] Trial Registered Prospectively |
| Last Modified On: |
13/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Ketorolac 30 mg Sublingual tablet in the Acute treatment of Migraine headache. |
|
Scientific Title of Study
|
A multicentre prospective randomized double-blind placebo-controlled study to evaluate the efficacy and safety of ketorolac 30 mg sublingual tablet in the acute treatment of migraine headache |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT/54/01/19 Version 1 dated 18 Jul 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arun Maseeh |
| Designation |
Sr.Vice President |
| Affiliation |
Troikaa Pharmaceuticals Ltd |
| Address |
Troikaa Pharmaceuticals Ltd
commerce house 1 satya marg
bodakdev Ahmedabad
Ahmadabad
GUJARAT
380054
India |
| Phone |
07926856242 |
| Fax |
|
| Email |
arunmaseeh@troikaapharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Maseeh |
| Designation |
Sr.Vice President |
| Affiliation |
Troikaa Pharmaceuticals Ltd |
| Address |
Troikaa Pharmaceuticals Ltd
commerce house 1 satya marg
bodakdev Ahmedabad
GUJARAT
380054
India |
| Phone |
07926856242 |
| Fax |
|
| Email |
arunmaseeh@troikaapharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Pratik Shah |
| Designation |
Project Manager Medical services |
| Affiliation |
Troikaa Pharmaceuticals Limited |
| Address |
Troikaa Pharmaceuticals Ltd
commerce house 1 satya marg
bodakdev Ahmedabad
Ahmadabad
GUJARAT
380054
India |
| Phone |
07926856242 |
| Fax |
|
| Email |
pratikshah@troikaapharma.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Troikaa Pharmaceuticals Ltd |
| Address |
Troikaa Pharmaceuticals Ltd
commerce house 1 satya marg
bodakdev Ahmedabad |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 18 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rahul Jankar |
AIMS Hospital |
2, Milap Nagar, MIDC, Dombivli (E) -421203
Thane
MAHARASHTRA |
9686816866
rahul_jankar60@yahoo.co.in |
| Dr Debananda Sahoo |
All India Institute of Medical Sciences |
Sijua Patrapada Bhubaneswar
Khordha
ORISSA |
8763290804
drdebanandasahoo@gmail.com |
| Dr Sudhir Kumar |
Apollo Hospitals |
Jubilee Hills, Hyderabad, 500033
Hyderabad
TELANGANA |
9573143915
drsudhirkumar@yahoo.com |
| Dr Mukesh Sharma |
Apollo Hospitals International Ltd |
Department of Neurology ground floor Apollo Hospitals International Ltd
Plot 1A bhat GIDC Estate Gandhinagar
Gandhinagar
GUJARAT |
9375488882
drmukeshneuro@rediffmail.com |
| Dr Lalla Rakesh Shyam |
Ashirwad Hospital and Research Centre |
Maratha Section , Near Jijamata Udyan, Ulhasnagar
Thane
MAHARASHTRA |
9769337948
rakesh_lalla@yahoo.com |
| Dr Praveen Kumar S |
Bangalore Medical College & Research Institute |
Dept of Neurology
PMSSY
BMCRI
Victoria Hospital Campus
K R Road Fort
Bangalore 560002
Bangalore
KARNATAKA |
9448685155
dmpraveen@gmail.com |
| Dr Amol Yeole |
Dhadiwal Hospital |
Opp. New CBS Trambakeshwar Rd, Nashik, Maharashtra 422002
Nashik
MAHARASHTRA |
7588554530
amit_yeole37@rediffmail.com |
| Dr Ajay Agarwal |
Fortis Hospital |
Department of Medicine first floor Fortis Hospital
B-22, sector-62 Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9910258977
ajay.agarwal@fortishealthcare.com |
| Dr Mohit Chaturvedi |
G.P. Shekhawati Hospital and Research Center |
A/2 opp. Time square Central Spine, Vidhyanagar, 302039
Jaipur
RAJASTHAN |
9829931085
crshekhavatiHospital@gmail.com |
| Dr Richa Giri |
GSVM Medical College |
swaroop nagar Kanpur 208002
Kanpur Nagar
UTTAR PRADESH |
05122535403
drrichagiri.gsvm@gmail.com |
| Dr Nikalje Rajkumar |
Lifepoint Multispeciality Hospital |
Department of Medicine third floor Lifepoint Multispeciality Hospital
145/1 Mumbai Bangalore Highway near hotal sayaji wakad
Pune
MAHARASHTRA |
9028560535
nikaljeraj80@gmail.com |
| Dr Manjiri Naik |
Mahatma Gandhi Mission Medical college and hospital |
Department of Medicine ground floor Mahatma Gandhi Mission Medical college and hospital N-6
CIDCO Aurangabad 431003
Aurangabad
MAHARASHTRA |
9422202905
manjirirnaik@gmail.com |
| Dr AmitKumar Pande |
Medipoint Hospitals Pvt Ltd |
Department of Neurology third floor Medipoint Hospitals Pvt Ltd
241/1 New D P Road Aundh
Pune
MAHARASHTRA |
9860918000
dramitkumarpande.pentagon@gmail.com |
| Dr Dinesh Jaluka |
R.G. Kar Medical College |
Department of Neurology ground floor R.G. Kar Medical College
1, khudiram bose sarani
Kolkata
WEST BENGAL |
9830440059
drjaluka@hotmail.com |
| Dr P C Mohan |
Santosh Hospital |
6/1 Promenade road behind coles park Bangalore 560005
Bangalore
KARNATAKA |
9341218862
kpcmohan@yahoo.co.in |
| Dr Ish Anand |
Sir Ganga Ram Hospital |
Sir Ganga Ram Hospital Marg Rajinder Nagar New Delhi 110060
New Delhi
DELHI |
9810033099
ishneuro@yahoo.com |
| Dr Hemant Gupta |
Sir JJ Hospital |
JJ marg byculla Mumbai Central 400008
Mumbai
MAHARASHTRA |
9870456888
drhemantgupta@hotmail.com |
| Dr SS Dariya |
SMS Medical College and Attached Hospital |
JLN Marg Jaipur 302004
Jaipur
RAJASTHAN |
9414270277
drssdariya@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 16 |
| Name of Committee |
Approval Status |
| Ashirwad Ethics Committee |
Approved |
| Ethics Committee (For Clinical trials and BABE study) |
Approved |
| Ethics committee of Bangalore College and Research Institute |
Approved |
| Ethics Committee Sir Ganga Ram Hospital |
Approved |
| Fortis hospital Institutional Ethics committee |
Approved |
| Instituational Ethics committee |
Approved |
| Institutional Ethics committee |
Approved |
| Institutional Ethics committtee- Clinical Studies |
Approved |
| Institutional Research Committee AIIMS |
Approved |
| LPR Ethics Committee |
Approved |
| Mahatma Gandhi Mission Ethics committee for research of Human subjects |
Approved |
| Office of Ethics Committee, SMS Medical College and attached Hospital |
Approved |
| Pentamed Ethics Committee |
Approved |
| Santosh Hospital Institutional Ethics |
Approved |
| SHREE INSTITUTIONAL ETHICS COMMITTEE (SIEC) |
Approved |
| Suraksha Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G891||Acute pain, not elsewhere classified. Ayurveda Condition: NOT Applicable, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ketorolac Sublingual Tablets 30 mg manufactured by Troikaa Pharmaceuticals Ltd |
1st dose will be taken upon experiencing Migraine Headache
Total daily dose of Ketorolac should not exceed 120 mg & continuous dosing of ketorolac should not exceed 5 days |
| Comparator Agent |
Placebo matching Ketorolac Sublingual tablet 30 mg manufactured by Troikaa Pharmaceuticals Ltd. |
1st dose will be taken upon experiencing Migraine Headache
Total daily dose of Ketorolac should not exceed 120 mg & continuous dosing of ketorolac should not exceed 5 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Male and female adult patients aged 18 to 65 years and having the diagnosis of migraine with or without aura according to the International Headache Societys criteria for migraine ICHD3 2018
History of diagnosis of migraine before the age of 50 years
Subjects must be compliant with self administration of medication and willing to fillup the migraine diary provided to them as required for the study
At least a 1year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders 3rd edition beta version ICHD3
Migraine episodes that are separated by at least 72 hours of headache pain freedom will be included
History of 2 to 8 migraine attacks per month with moderate to severe headache pain in each of the 3 months prior to Screening |
|
| ExclusionCriteria |
| Details |
All headache types other than migraine
Has taken medication for acute treatment of headache including acetaminophen nonsteroidal anti inflammatory drugs NSAIDs triptans ergotamine opioids or combination analgesics on 10 or more days per month in the previous 3 months
Required hospital treatment of a migraine attack 3 or more times in the previous 6 months
Has a chronic non headache pain condition requiring daily pain medication
Has a history of malignancy in the prior 5 years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
Has a history of any prior gastrointestinal conditions eg diarrhea syndromes inflammatory bowel disease that may affect the absorption or metabolism of the investigational product participants with prior gastric bariatric interventions which have been reversed are not excluded
Patients with active peptic ulcer disease recent gastrointestinal bleeding or perforation
Patients with a history of peptic ulcer disease or gastrointestinal bleeding
Elderly patients at a greater risk for serious gastrointestinal events age more than 65 years
Has a history of hepatitis within the previous 6 months
Pregnancy or breastfeeding
Subjects who within one year had a clinically significant medical history of bleeding problems coagulation abnormalities hemorrhagic disease anemia bone marrow suppression immunosuppression motility dysfunction or any condition that could interfere with the absorption distribution metabolism or excretion of the study medication
Subjects who are diagnosed and or treated for inflammatory bowel disease or pancreatic disease serious cardiovascular disease or history of serious cardiovascular disease or stroke renal hepatic endocrine pulmonary neurologic disease Type I or II diabetes mellitus uncontrolled hypertension or malignancy not in remission
Subjects who are taking drugs like antiplatelet agents and or anticoagulants
Uncontrolled hypertension Systolic greater than 150 and Diastolic greater than 95 mm of Hg |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The proportion of patients achieving Pain Free at 2 hours post dose as compared to placebo
Pain freedom defined as a reduction in headache severity from moderate severe at baseline to no pain at 2 hours after the initial dose
The proportion of patients with freedom from the most bothersome symptom MBS from among nausea photophobia and phonophobia at 2 hours after the initial dose |
Pain intensity difference PID at each evaluation 30 minutes and 1 1 5 2 3 4 6 12 24 48 72 96 120 hours post dose |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage of Participants with Pain Relief at 2 Hours after the Initial Dose Time Frame Baseline Predose to 2 hours after the initial dose
Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours After Initial Dose Time Frame 2 to 24 hours after initial dose
|
Pain intensity difference PID at each evaluation 30 minutes and 1 1 5 2 3 4 6 12 24 48 72 96 120 hours post dose |
|
Target Sample Size
Modification(s)
|
Total Sample Size="696"
Sample Size from India="696"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
22/04/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Efficacy of Ketorolac parenteral formulations in migraine attack has been studied in many clinical trials. In a comparative clinical study of intravenous Ketorolac vs. nasal Sumatriptan conducted in 29 patients with migraine headache demonstrated that intravenous ketorolac produced greater pain reduction in pain compared to nasal Sumatriptan. A systemic review on 141 patients treated with acute migraine stated that, Ketorolac was more effective than intranasal sumatriptan. While there was no difference in pain relief between ketorolac and phenothiazine agents. Availability of Ketorolac Sublingual tablets will help in quick and easy administration of the treatment by the patient, without aid of the medical staff and thus may lead to quick relief from migraine pain. Based on above information, Troikaa proposes to conduct this phase III Clinical Trial for regulatory approval of Ketorolac Tromethamine Sublingual 30 mg for treatment of Migraine headache. |