CTRI/2020/09/027952 [Registered on: 22/09/2020] Trial Registered Prospectively
Last Modified On:
29/09/2021
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Other
Public Title of Study
The Efficacy and Safety of Triamcinolone Acetonide 0.1% w/w and Lignocaine Hydrochloride 2.0% w/w Oromucosal Gel in Patients with Mouth Ulcers.
Scientific Title of Study
A Prospective, Randomized, Open-label, Comparative, Multi-Centric, Phase III Clinical Study to Evaluate the Efficacy and Safety of Triamcinolone Acetonide 0.1% w/w and Lignocaine Hydrochloride 2.0% w/w Oromucosal Gel with Dologel-CT (Choline Salicylate 8.7% w/w, Lignocaine Hydrochloride 2.0% w/w, and Benzalkonium Chloride 0.01% w/w) in Treatment of Recurrent Aphthous Stomatitis
Trial Acronym
TALO3001/ TAILOR
Secondary IDs if Any
Secondary ID
Identifier
TALO3001_Protocol Version 1.1 dated 06 March 2020
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Vikas Sethi
Designation
Sr. Consultant, Vice Chairman, Dept of Dental Surgery
Affiliation
Sir Gangaram Hospital
Address
Sir Gangaram Hospital,
Rajindra Nagar New Delhi - 110060
New Delhi DELHI 110060 India
Phone
9212011598
Fax
Email
drvsethi@gmail.com
Details of Contact Person Scientific Query
Name
Dr Swati Biswas
Designation
Head Clinical Development
Affiliation
Abbott Heathcare Pvt Ltd
Address
Floor 16, Godrej BKC, Plot C 68, BKC, Near MCA Club, Bandra East, Mumbai
Mumbai MAHARASHTRA 400051 India
Phone
Fax
Email
swati.biswas@abbott.com
Details of Contact Person Public Query
Name
Dr Shivani Acharya
Designation
Associate Director Clinical Development & PV
Affiliation
Abbott Heathcare Pvt Ltd
Address
Abbott Heathcare Pvt Ltd, Floor 16, Godrej BKC, Plot C 68, BKC, Near MCA Club, Bandra East, Mumbai.
Mumbai MAHARASHTRA 400051 India
Phone
Fax
Email
shivani.acharya@abbott.com
Source of Monetary or Material Support
Abbott Healthcare Pvt. Ltd Floor 13-19, Godrej BKC Plot No.C-68,
BKC Near MCA Club, Bandra (E) Mumbai-400051, Maharashtra,
India.
Primary Sponsor
Name
Abbott Healthcare Pvt Ltd
Address
Abbott Healthcare Pvt. Ltd
Floor 13-19, Godrej BKC
Plot No.C-68, BKC
Near MCA Club, Bandra (E)
Mumbai-400051, Maharashtra, India
Dr.Vasantrao Pawar.Medical College, Hospital and Research Center
Dental Department, Dr.Vasantrao Pawar.Medical College, Hospital and Research Centre,
4th Floor near MRD section in Centre For Developmental Therapeutics Translational Research, Vasantdada Nagar, Adgaon, Nashik, Maharashtra 422003 Nashik MAHARASHTRA
7875002421
archiespagar@gmail.com
Dr V Varaprasad
King George Hospital
King George Hospital,
Department of Dental Surgery,
Andhra medical College,
Maharani Peta,
King George Hospital,
Visakhapatnam, Andhra Pradesh 530002 Visakhapatnam ANDHRA PRADESH
9849124544
vvaraprasadclinicalresearch@gmail.com
Dr Uma Shanker Pal
King George Medical university
King George Medical University, department of oral and maxillofacial surgery, Faculty of Dental sciences, King Georges Medical University chowk, Shahmeena Road, Lucknow- 226003, utter pradesh Lucknow UTTAR PRADESH
9415006417
druspalkgmc@gmail.com
Dr Shashank Tiwari
KRM Hospital and Research Centre
Dental Department, KRM Hospital and Research Centre, 3/97, Vijayant Khand, Gomti Nagar, Lucknow, Uttar Pradesh, 226010 Lucknow UTTAR PRADESH
9838172269
drs.tiwari@hotmail.com
Dr Tushar Ghode
Lifepoint Multispeciality Hospital
Dental Department, Lifepoint Multispeciality Hospital, 145/1, Mumbai Banglore Highway, Near Hotel Sayaji, Wakad, Pune-411057 Pune MAHARASHTRA
8767762332
tusharghode@gmail.com
Dr Vishal Prabhakar Dewalwar
Lokmanya Tilak Municipal Medical college & General Hospital
Dental Department, Lokmanya Tilak Municipal Medical college & General Hospital, Dr. Ambedkar Road, Sion, Mumbai 400022 Mumbai MAHARASHTRA
09545453354
vishal.dewalwar@gmail.com
Dr Sujata S Reddy
M S Ramaiah Medical College and Hospital
Dental Department, M. S. Ramaiah Medical College and Hospital, faculty of dental science, M.S. Ramaiah nagar, MSRIT Post, Bangalore, Karnataka 560054 Bangalore KARNATAKA
8023148915
s_sujathajanardhan@yahoo.com
Dr Padmalatha GV
Medstar Speciality Hospital
Dental Department, No 641/17/1/3, Kodigehalli Main Road, Sahakarnagar post, Bangalore – 560092, Karnataka, India Bangalore KARNATAKA
8041127524
medstarclinicalresearch.dentist@gmail.com
Dr Abhik Pyne
Peerless Hospitex Hospital & Research Centre Ltd
Dental Department, Peerless Hospitex Hospital & Research Centre Ltd.
360, Pancha Sayar Road, Sahid Smirity Colony, Pancha Sayar, Kolkata 700094, West Bengal, India. Kolkata WEST BENGAL
09007466754
drabhikpyne@gmail.com
Dr Vikas Sethi
Sir Gangaram Hospital
Sir Ganga Ram Hospital, department of dental surgery, Sir Ganga Ram Hospital marg, Rajinder Nagar, New Delhi – 110060, Delhi Central DELHI
Dose: A small dab or pea sized amount of gel to be applied topically on ulcer thrice daily for 7 days Frequency: thrice daily for 7 days Route of Administration: Oral Duration of Therapy: 7 days
Intervention
Triamcinolone Acetonide 0.1% w/w and Lignocaine Hydrochloride 2.0% w/w
Dose: About 6 mm of gel to be applied topically on ulcer thrice daily for 7 days
Frequency: Thrice daily for 7 days
Route of administration: Oral
Duration of therapy: 7 days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
50.00 Year(s)
Gender
Both
Details
A patient must fulfil all the following criteria for inclusion in this study:
1. Males and females between ages 18 and 50 years (both inclusive).
2. Females of childbearing potential must have a negative pregnancy test, be non-lactating, and willing to use adequate and reliable contraception (defined as intrauterine device, contraceptive pill or depot gestagen) throughout the study
3. History of recurrence ulcers in oral cavity with at least two episodes of minor and/or major RAS last year with no signs of systemic disease
4. Presence of mucosal oral ulcers, each measuring 2 mm to 3 cm in size
5. Moderate to severe pain (≥ 40 mm on 100 mm VAS) on the day of baseline visit
6. Patients willing to comply with the study procedures and requirements
7. Patients willing to sign and date written informed consent to participate in the study
ExclusionCriteria
Details
A patient will not be included in the study if they meet any of the exclusion criteria:
1. History of systemic diseases/illnesses causing oral ulceration like autoimmune conditions (systemic lupus erythematosus, Kawasaki disease), inflammatory conditions (Crohn’s disease, ulcerative colitis), gluten-sensitive enteropathy, dermatoses, drug eruptions, Behcet’s disease, Reiter syndrome, allergic conditions
2. Patients with herpetiform ulceration
3. Ulcers present at pharyngeal area
4. Patients with significant past history of cardiovascular disease (e.g. bradycardia or impaired cardiovascular function, ischemic heart disease, severe shock), impaired hepatic and renal function, sepsis, epilepsy; diabetes, uncontrolled hypertension, acid peptic disease, iron deficiency anemia, bleeding disorders, erosive gastritis, asthma, dehydration, neutropenia, folic acid or tuberculosis, association of ulcers with luteal phase of menstruation in female patients and other infections that may contraindicate treatment, as per Investigator discretion
5. Patients diagnosed with anxiety, mental or psychological disorders
6. Patients known to have hematinic deficiency or getting treatment for same
7. Patients undergoing dental treatment, with removable prosthetic rehabilitations or orthodontic appliances or having active periodontitis
8. Known history of hypersensitivity to local anesthetics of the amide type (e.g. Prilocaine, Mepivacaine) ester local anesthetics or corticosteroids or to other components in the formulation like methylparaben and/or propyl paraben or to their metabolite para aminobenzoic acid or choline salicylate
9. Patients on concomitant medications that may interact with study medication like anti-arrhythmic (e.g. Mexiletine, Amiodarone), antidepressants, sedative-hypnotics, psychotropic drugs
10. Participation in any other clinical study in past 30 days
11. Patients with other mucosal lesions with minor/major RAS and/or bacterial, yeast, viral or fungal infection at or near the proposed area of topical application
12. Ingestion of any chemotherapeutic drugs, immunomodulators or systemic corticosteroids in the recent 1 year
13. Patients whose ulcers clinically seem malignant in nature to the Investigator
14. Females who are pregnant/planning to become pregnant/not ready to use contraceptive measures or are lactating
15. Patients who are unsuitable for any other reason to participate in the study in the opinion of the Investigator
16. Patients who uses topical gel other than the study medication
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
On-site computer system
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To evaluate healing of ulcer from baseline (prior to gel application on Day 1) to Day 4 between Triamcinolone Acetonide 0.1% w/w and Lignocaine Hydrochloride 2.0% w/w Oromucosal Gel and Dologel-CT, when used in the treatment of recurrent aphthous stomatitis (RAS)
Baseline to Day 4
Secondary Outcome
Outcome
TimePoints
To evaluate healing of ulcers from baseline (prior to gel application on Day 1) to Days 6 and 8 within and between Triamcinolone Acetonide 0.1% w/w and Lignocaine Hydrochloride 2.0% w/w Oromucosal Gel and Dologel-CT
Baseline to Day 6
To evaluate erythema and burning sensation scores from baseline (prior to gel application on Day 1) to Days 4, 6, and 8 within and between Triamcinolone Acetonide 0.1% w/w and Lignocaine Hydrochloride 2.0% w/w Oromucosal Gel and Dologel-CT
Baseline to Day 4,6 & 8
To evaluate pain intensity from baseline (prior to gel application on Day 1) to Days 4, 6, and 8 within and between Triamcinolone Acetonide 0.1% w/w and Lignocaine Hydrochloride 2.0% w/w Oromucosal Gel and Dologel-CT
Baseline to Day 4,6 & 8
To evaluate percentage of responders to the treatment from baseline (prior to gel application on Day 1) to Days 4, 6, and 8 within and between Triamcinolone Acetonide 0.1% w/w and Lignocaine Hydrochloride 2.0% w/w Oromucosal Gel and Dologel-CT
Baseline to Day 4, 6 & 8
To evaluate number of days of ulcer healing within and between Triamcinolone Acetonide 0.1% w/w and Lignocaine Hydrochloride 2.0% w/w Oromucosal Gel and Dologel-CT
Baseline to Day 8
To evaluate improvement in patient daily activities on Days 4, 6, and 8 as compared to baseline (prior to gel application on Day 1) within and between Triamcinolone Acetonide 0.1% w/w and Lignocaine Hydrochloride 2.0% w/w Oromucosal Gel and Dologel-CT
Day 4, 6 & 8
Target Sample Size
Total Sample Size="112" Sample Size from India="112" Final Enrollment numbers achieved (Total)= "112" Final Enrollment numbers achieved (India)="112"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is A Prospective, Randomized, Open-label, Comparative,
Multi-Centric, Phase III Clinical Study. The purpose of the study is to
Evaluate the Efficacy and Safety of Triamcinolone Acetonide 0.1% w/w and
Lignocaine Hydrochloride 2.0% w/w Oromucosal Gel with Dologel-CT® in Treatment
of Recurrent Aphthous Stomatitis. The objective is to evaluate healing of ulcer
from baseline to Day 4 between the test and reference product. The study is not
yet published.