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CTRI Number  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 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Naga Babu  Andhra Medical College, King George Hospital  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 
9391075600

b_ravishankar@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Clinical Research Ethics Committee Medica Super specialty Hospital  Approved 
EC Atharva Multispeciality Hospital and research Centre  Approved 
EC GSVM Medical College  Approved 
EC Jehangir Clinical Development Centre Pv.Ltd.  Approved 
EC Yashoda Academy of Medical Education and Research  Approved 
Government Medical College, Institutional Ethics Committee  Approved 
IEC King George Hospital  Approved 
INSTITUTIONAL ETHICS COMMITTEE SRIHER  Approved 
Meera Institutional Ethics Committee  Approved 
Popular Hospital EC  Approved 
Suraksha Institute Ethics Committee  Approved 
Vrajesh Hospital Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K602||Anal fissure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CremaGel®  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" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   10/02/2021 
Date of Study Completion (India) 18/11/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
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  

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.

 
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