CTRI/2021/02/030971 [Registered on: 03/02/2021] Trial Registered Prospectively
Last Modified On:
05/01/2022
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Clinical Study to Evaluate the Efficacy and
Safety of Fixed Dose Combination for treatment of Anal Fissure.
Scientific Title of Study
A Prospective, Randomized, Open-Label, Comparative,
Multicentric Phase III Clinical Study to Evaluate the Efficacy and
Safety of Fixed Dose Combination of Diltiazem Hydrochloride
2% w/w and Lidocaine Hydrochloride 2% w/w Gel against
Diltiazem Hydrochloride Gel 2% w/w in the Treatment of Anal
Fissure
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
DILI3001, Version no. 00, dated 18 March 2020
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Kushal Mital
Designation
Surgical Gastroenterologist, Proctologist
Affiliation
Medicare Hospital
Address
Medicare Hospital, Gastroenterology Department Silver Plaza, 1st floor, Ramchandra Nagar, Next to Nitin Flyover Junction, E.S.I.S Road, Thane 400604, Maharashtra
Thane MAHARASHTRA 400604 India
Phone
9869004510
Fax
Email
kushalmital@gmail.com
Details of Contact Person Scientific Query
Name
Dr Shivani Acharya
Designation
Associate Director Clinical Development & PV
Affiliation
Abbott India Limited
Address
Abbott India Limited Floor 16, Clinical Research Deptartment,
Godrej BKC Plot C 68 BKC Near MCA Club Bandra East Mumbai
Mumbai
MAHARASHTRA
400051
Mumbai MAHARASHTRA 400051 India
Phone
Fax
Email
shivani.acharya@abbott.com
Details of Contact Person Public Query
Name
Dr Shivani Acharya
Designation
Associate Director Clinical Development & PV
Affiliation
Abbott India Limited
Address
Abbott India Limited Floor 16, Clinical Research Deptartment,
Godrej BKC Plot C 68 BKC Near MCA Club Bandra East Mumbai
Mumbai
MAHARASHTRA
400051
Mumbai MAHARASHTRA 400051 India
Phone
Fax
Email
shivani.acharya@abbott.com
Source of Monetary or Material Support
Abbott India Ltd Floor 15-16, Godrej BKC Plot No.C-68, BKC Near MCA Club, Bandra
(E) Mumbai-400051, Maharashtra, India.
Primary Sponsor
Name
Abbott India Ltd
Address
Floor 15-16, Godrej BKC Plot No.C-68, BKC Near MCA Club, Bandra
(E) Mumbai-400051, Maharashtra, India
Clinical Research Room, Department of Surgery, King George Hospital, Maharanipeta
Visakhapatnam. 530002. Andhra Pradesh, India Visakhapatnam ANDHRA PRADESH
9849652094
tvssnagababu@gmail.com
Dr Sanjeev Mohan
Atharva Multispecialty Hospital and Research Center
Atharva Multispecialty Hospital and Research Center, Department of Surgery H-
4/comm-2 construction Div 2, UP Avas Vikas Parishad, Sector -E, Lucknow-226003, Uttar Pradesh,
India Lucknow UTTAR PRADESH
9839013867
Hospital.atharva@gmail.com
Dr Raj Gajbhiye
Government Medical College and Hospital
Department of Surgery, Modular OT F Surgery, 2nd Floor, Government Medical College and Hospital, Nagpur-440003, India Nagpur MAHARASHTRA
9422101440
rajgajbhiye@hotmail.com
Dr R K Jauhari
GSVM Medical College
Department of Surgery, GSVM Medical College, Swarrop Nagar, Kanpur-208002, Uttar Pradesh Kanpur Nagar UTTAR PRADESH
9453574632
dr_ramendra@yahoo.com
Dr Pradeep Sharma
Jehangir Clinical Development Centre Pvt. Ltd
Jehangir Clinical Development Centre Pvt. Ltd. Department of Surgery Jehangir Hospital Premises , 32 , Sassoon Road , Pune – 411001, India Pune MAHARASHTRA
9371016344
drpradeepsharma@gmail.com
Dr Rahul Dhar
Medica Superspeciality Hospital
Medica Superspeciality Hospital, Clinical Research Department, 127, Eastern Metropolitan Bypass, Mukundapur, Kolkata-700099, West Bengal, India Kolkata WEST BENGAL
8100187472
dr.rdhar@gmail.com
Dr Kushal Mital
Medicare Hospital
Medicare Hospital, Department Gastroenterology Silver Plaza, 1st floor, Ramchandra Nagar, Next to Nitin Flyover Junction, E.S.I.S Road, Thane 400604, Thane MAHARASHTRA
9869004510
kushalmital@gmail.com
Dr Nitin Zabak
Meera Hospital
Meera Hospital, Department of Surgery Devi Bhavan, Beside Dr. Acharyas Hospital, Nr. Zojwala Petrol Pump, Bail Bazar, Kalyan (W) 421301, Mumbai, Maharashtra, India Mumbai MAHARASHTRA
7710949494
nitinzabak@yahoo.com
Dr Indraneel Basu
Popular Hospital
Popular Hospital, Department of Medicine N10/60, A-2, DLW Road Kakarmatta, Varanasi-221004, Uttar Pradesh, India Varanasi UTTAR PRADESH
9935036063
dribasumd@yahoo.co.in
Dr Apoorva Patel
Shree Vrajesh Surgical Hospital
clinical research department in basement,
Opposite Rajpath Club,
Cargo Motor Lane,
S.G Road, Bodakdev,
Ahmedabad -380015,
Gujarat, India
Ahmadabad GUJARAT
9825012660
drapoorvapatel@hotmail.com
Dr K Balaji
Sri Ramachandra Institute of Higher Education and Research (DU)
Sri Ramachandra Institute of Higher Education and Research (DU), Clinical Research Division, Dental College Basement No: 1, Ramachandra Nagar, Porur, Chennai-600116, Tamil Nadu, India Chennai TAMIL NADU
9841044913
drbalajisingh@gmail.com
Dr Ravi Shankar
Yashoda Hospitals
Yashoda Hospitals, Department of Gastroenterology, Behind Hari Hara Kala Bhavan, SP Road. Secundrabad-5000003, Telangana, India Hyderabad TELANGANA
Diltiazem Hydrochloride gel 2% w/w, Each patient will apply ref product gel equivalent to 2 cm 3 times a day (morning, afternoon /evening, and at bedtime) in anal canal for 40 days ± 2 days
Intervention
FDC of Diltiazem Hydrochloride 2% w/w and Lidocaine
Hydrochloride 2% w/w
FDC of Diltiazem Hydrochloride 2% w/w and Lidocaine
Hydrochloride 2% w/w in a gel base, Each patient will apply the test product gel equivalent to 2 cm 3 times a day (morning, afternoon /evening, and at bedtime) in anal canal for 40 days ± 2 days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
64.00 Year(s)
Gender
Both
Details
1) Males and females with age 18 to 64 years (both inclusive) with a diagnosis of anal
fissure
2) Patients with anal fissure having moderate to severe anal pain (VAS score ≥ 45 mm on
100 mm VAS scale) at baseline
3) Females of childbearing potential must have a negative pregnancy test, be non-lactating,
and willing to use an adequate and reliable contraception (defined as intrauterine device,
contraceptive pill or progesterone) throughout the study
4) Patients who are willing to comply with the study procedures and requirements
5) Patients who are willing to stop all other concomitant topical preparations applied
peri-anally prior to commencing the study product and throughout the study Patients who
understand the requirement of the study and are willing to sign and date the informed
consent before participating in the study
ExclusionCriteria
Details
1) Patients unwilling to have an examination of anal fissure
2) Patients having anal fistulas or anal fissure of various causes such as Crohn disease, anal
suppuration, and abscesses
3) Patients who have a history of or active gastrointestinal disorders like inflammatory
bowel disease, chronic fecal incontinence or a history of chronic constipation or
constipation in 4 weeks prior to screening (defined as 2 or less defecations per week;
associated with straining/passage of hard stools), anal abscess, or fixed anal
stenosis/fibrosis
4) Patients with a history of neoplastic disease within 5 years
5) Patients with associated acute hemorrhoidal attacks
6) Patients having anal or peri-anal cancer
7) Patients who have had lateral sphincterotomy or anal stretch or other previous surgery
involving the anal canal or peri-anal region or have a history of radiation therapy to the
pelvis
8) Patients with a history of hepatic or renal impairment
9) Patients with a clinically significant history of renal, hepatic, neurological,
dermatological, immunological, major psychiatric (including drug or alcohol abusers), or
hematological illness or any clinically significant abnormal laboratory findings (as per
Investigator’s assessment from medical records)
10) Patients of hypertension / ischemic heart disease on oral calcium channel blockers
(CCBs)
11) Patients with anal fissure associated with other conditions (drug-induced [e.g. nicorandil],
trauma, human immunodeficiency virus infection, fistula-in-ano, inflammatory bowel
disease, peri-anal sepsis or malignancy)
12) Patients with a history of cardiovascular disease, history of reduced left ventricular
function, bradycardia, first degree atrioventricular block or prolonged PR interval (> 0.2 seconds / > 200 milliseconds) on ECG
13) Patients with a history of or active uncontrolled diabetes and/or hypertension
14) Patients who have previously received therapy with Diltiazem hydrochloride gel, other
topical CCBs or other topical medicated ointments etc. for past 3 days before screening
15) Patients with a history of human immunodeficiency virus or viral hepatitis positivity
16) Patients with a history of hypersensitivity to amide type local anesthetics or Diltiazem
17) Patients who have been previously treated surgically and patients taking oral CCBs,
nitrates, or any other vasodilators
18) Patients taking medications prohibited by the protocol
19) Patients with symptoms suggestive of urinary tract infection
20) Patients who are unsuitable for any other reason to participate in the study in the opinion
of the Investigator
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Mean reduction in anal pain intensity (on 100 mm VAS)between test group and reference group
from baseline (prior to application) to Day 10
Secondary Outcome
Outcome
TimePoints
Mean reduction in anal pain intensity (on 100 mm VAS)within test group and reference group
from baseline (prior to application) to Day 10
Mean reduction
in anal pain intensity (on 100 mm VAS)
baseline (prior to
application) to 0.5 hour, 1 hour, 2 hours, 4 hours, and 8 hours (post application)
on Day 1, Day 5, Day 25, and Day 40
Onset of some / partial relief in pain on Day 1 (0.5 hour, 1 hour, 2 hours, 4 hours,
and 8 hours after first application) between test group and reference group on a 5-
point scale ranging from “score 1†(no relief) to “score 5†(complete relief)
Day 1 (0.5 hour, 1 hour, 2 hours, 4 hours,
and 8 hours after first application)
Reduction in itching (on a 5-point scale) and bleeding (recorded as peri-anal
bleeding score)
From baseline (prior to application) to Day 5, Day 10, Day 25, and
Day 40
Proportion of patients with partial / complete healing of anal fissure
At Day 5, Day10, Day 25, and Day 40
Mean time to complete healing of anal fissure
Day 1 to Day 40
Number of rescue medication (Diclofenac 50 mg) tablets and the average daily dose
taken by a patient
At Day 5, Day 10, Day 25, and Day 40
Patient and Investigator global assessment of treatment
at Day 5, Day 10, Day 25, and Day 40
Target Sample Size
Total Sample Size="326" Sample Size from India="326" Final Enrollment numbers achieved (Total)= "326" Final Enrollment numbers achieved (India)="326"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is Prospective, Randomized, Open-Label, Comparative, Multicentric Phase III Clinical Study will be conducted Approximately 8 to 12 centers across India to Evaluate the Efficacy and Safety of Fixed Dose Combination of Diltiazem Hydrochloride 2% w/w and Lidocaine Hydrochloride 2% w/w Gel against Diltiazem Hydrochloride Gel 2% w/w in the Treatment of Anal Fissure and 326 Patients will be enrolled between age of 18 to 64.