| CTRI Number |
CTRI/2024/09/073830 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on the Safety and Effectiveness of Nifedipine and Lidocaine cream for Treating Anal Fissures. |
|
Scientific Title of Study
|
A Prospective, Open Label, Single-Arm, Non-Comparative, Study to Evaluate The Effectiveness & Safety Of Formulation Of Nifedipine and Lidocaine In Treatment Of Anal Fissure |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NILC-522-0217 dated 19.06.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajasekhar Mysore |
| Designation |
Principal Investigator |
| Affiliation |
Chirag Global Hospital |
| Address |
Department of Proctology,
Room no 101
Chirag Global Hospital, 103, 2nd Stage, BTM layout, Dollars Colony
Bangalore
KARNATAKA
560076
India |
| Phone |
|
| Fax |
|
| Email |
chiraghospital@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivani Acharya |
| Designation |
Director - Clinical Development & Operations |
| Affiliation |
Abbott India Limited |
| Address |
Floor 16, Godrej BKC, Plot No C-68,
Bandra Kurla Complex,
Bandra East,
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400051
India |
| Phone |
8657552543 |
| Fax |
|
| Email |
shivani.acharya@abbott.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Acharya |
| Designation |
Director - Clinical Development & Operations |
| Affiliation |
Abbott India Limited |
| Address |
Floor 16, Godrej BKC, Plot No C-68,
Bandra Kurla Complex,
Bandra East,
Mumbai
MAHARASHTRA
400051
India |
| Phone |
8657552543 |
| Fax |
|
| Email |
shivani.acharya@abbott.com |
|
|
Source of Monetary or Material Support
|
| Abbott India Limited
3, Corporate Park, Sion- trombay Park, Maharashtra (India)- 400071 |
|
|
Primary Sponsor
|
| Name |
Abbott India Limited |
| Address |
3, Corporate Park, Sion- Trombay Park, Maharashtra (India)- 400071 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajasekhar Mysore |
Chirag Global Hospital |
Department of Proctology,
Room no 101
103, 2nd Stage, BTM layout, Dollars Colony, Bangalore -560076
Bangalore
KARNATAKA |
9741389013
chiraghospital@gmail.com |
| Dr Nitin Bhople Anna |
Galaxy Superspeciality Hospital |
Agnihotra Chowk opp. to Punjab National Bank
Ulkanagari, Aurangabad, Maharashtra 431001
Aurangabad
MAHARASHTRA |
9766138367
dr.nitinbhople.gastro@gmail.com |
| Dr Bhate Prasad Ashok |
Lifepoint Multispeciality Hospital |
Lifepoint Multispeciality Hospital, 145/1, Mumbai-Banglore Highway, Near Hotel Sayaji, Wakad,Pune-411057
Pune
MAHARASHTRA |
9920039265
drprasadbhate78@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethics Committee of Ishwar Institute of Healthcare |
Approved |
| Lifepoint Research Ethics Committee |
Approved |
| Sri Durgamba Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K602||Anal fissure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fixed Dose Formulation Of Nifedipine 0.3% w/w Plus Lidocaine 1.5% w/w cream |
In this study patients will be prescribed a fixed-dose formulation of nifedipine and lidocaine cream, to be applied topically prior to the urgency to pass stools, with the help of a unique Accurate Rectal Applicator (AcuReApt), daily for a period of Six (6)-weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female patients aged 18 years and above, with a diagnosis of Acute or Uncomplicated Chronic anal fissure.
2. Patients with anal fissures who had moderate to severe anal pain (VAS score ≥45 mm [4.5 cm] on 100 mm [10 cm] VAS scale) at baseline.
3. Women of childbearing potential who had a negative pregnancy test, were non-lactating and were willing to use adequate and reliable contraception (defined as intrauterine device, contraceptive pill, or progesterone) throughout the study
4. Patients willing to comply with study procedures and requirements.
5. Patients willing to stop all other concomitant topical preparations applied peri-anally prior to commencing the study product and throughout the study.
6. Patients who understood the requirements of the study and were willing to sign and date the informed consent form before participating in the study
|
|
| ExclusionCriteria |
| Details |
1. Patients unwilling to have an examination of anal fissures.
2. Patients with complicated Chronic Anal fissures (With Infections), Anal fistulas, or anal fissures of various causes such as Crohns disease, anal suppuration, and abscesses.
3. Patients with a history of or active gastrointestinal (GI) disorders like inflammatory bowel disease, chronic fecal incontinence, or a history of chronic constipation or constipation in 4 weeks before screening (defined as 2 or fewer defecations per week, associated with straining/passage of hard stools), anal abscess, or fixed anal stenosis-fibrosis.
4. History of neoplastic disease within 5 years.
5. Patients having acute hemorrhoidal attacks.
6. Patients with anal or peri-anal cancer.
7. Patients with a history of lateral sphincterotomy or anal stretch or other previous surgery involving the anal canal or perianal region or history of radiation therapy to the pelvis.
8. Patients with a history of hepatic or renal impairment.
9. Patients with clinically significant (CS) history of renal, hepatic, neurological, dermatological, immunological, major psychiatric (including drug or alcohol abusers), or hematological illness or any CS abnormal laboratory findings (as per Investigator’s assessment from medical records).
10. Patients with a history of hypertension/ischemic heart disease and taking oral calcium channel blockers (CCBs).
11. Patients with anal fissures associated with other conditions (drug-induced [e.g., nicorandil], trauma, human immunodeficiency virus infection, fistula-in-ano, inflammatory bowel disease, perianal sepsis, or malignancy).
12. Patients with a history of cardiovascular disease, reduced left ventricular function, bradycardia, first-degree atrioventricular block, or prolonged PR interval (Greater than 0.2 seconds/ Greater than 200 milliseconds) on ECG.
13. Patients with a history of active uncontrolled diabetes (HbA1c Greater than 8%) and/or hypertension (Greater than 140/100 mmHg).
14. Patients with a history of previous therapy with Nifedipine or any other topical CCBs, or other topical medicated ointments for the past 3 days before screening.
15. Patients with a history of positivity for human immunodeficiency virus or viral hepatitis.
16. Patients with a history of hypersensitivity to amide-type local anesthetics or Nifedipine.
17. Patients with a history of previous surgical treatment and use of oral CCBs, nitrates, or any other vasodilators
18. Patients using medications prohibited by the study protocol.
19. Patients with symptoms that are suggestive of urinary tract infection.
20. Pregnant and nursing women.
21. Women with childbearing potential not practicing a reliable method of birth control.
22. Patients with a known history of hypersensitivity to lidocaine and nifedipine.
23. Patients with suspected inability or unwillingness to comply with study procedures.
24. Any unsuitable reasons to participate in the study in the opinion of the Investigator |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. The mean change in pain scores as measured by VAS from baseline (Day 1) to Week 6, post-treatment with the fixed-dose formulation of nifedipine and lidocaine in patients with anal fissures. |
Week 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Number and percentage of patients achieving healing of the fissure based on the degree of reepithelization of the fissure (scored as, 0: deep fissure still present, 1- superficial fissure, 2- partial reepithelization and 3- complete healing and reepithelization), post-6-weeks treatment with the fixed-dose formulation of nifedipine and lidocaine.
2. Frequency and percentage of patients with anal fissures requiring rescue medication(s), at Week 3 and 6, post-initiation of treatment with the fixed-dose formulation of nifedipine and lidocaine.
3. Global assessment of effectiveness, as rated by the physician (scored as Poor/ Good/ Very Good and Excellent), at Week 6.
4. Global assessment of effectiveness, as rated by the patient (scored as Poor/ Good/ Very Good and Excellent), at Week 6.
|
Week 3 and 6 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/09/2024 |
| Date of Study Completion (India) |
25/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
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, single-center, single-arm, open-label study designed to evaluate the effectiveness and safety of fixed-dose formulation of nifedipine 0.3% w/w and lidocaine 1.5% w/w to be applied topically in the management anal fissures in patients in the age group of 18 years and above. This study will enroll approximately 50 adult patients with anal fissures. The patients will be followed up for 6 weeks after enrollment into the study. |