Clinical Study to Evaluate the Efficacy andSafety of Fixed Dose Combination for treatment of Anal Fissure.

Phase 3

Completed

Conditions: Anal fissure, unspecified,

Registration Number: CTRI/2021/02/030971

Lead Sponsor: Abbott India Ltd

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 326

Inclusion Criteria

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 â‰¥ 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.

Exclusion Criteria

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 Investigatorâ€™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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Mean reduction in anal pain intensity (on 100 mm VAS)within test group and reference group	from baseline (prior to application) to Day 10
Reduction in itching (on a 5-point scale) and bleeding (recorded as peri-anal	bleeding score)
Mean time to complete healing of anal fissure	Day 1 to Day 40
Mean reduction	in anal pain intensity (on 100 mm VAS)
Patient and Investigator global assessment of treatment	at Day 5, Day 10, 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-
Proportion of patients with partial / complete healing of anal fissure	At Day 5, Day10, Day 25, and Day 40
Number of rescue medication (Diclofenac 50 mg) tablets and the average daily dose	taken by a patient

Trial Locations

Locations (12): Andhra Medical College, King George Hospital
🇮🇳
Visakhapatnam, ANDHRA PRADESH, India
Atharva Multispecialty Hospital and Research Center
🇮🇳
Lucknow, UTTAR PRADESH, India
Government Medical College and Hospital
🇮🇳
Nagpur, MAHARASHTRA, India
GSVM Medical College
🇮🇳
Nagar, UTTAR PRADESH, India
Jehangir Clinical Development Centre Pvt. Ltd
🇮🇳
Pune, MAHARASHTRA, India
Medica Superspeciality Hospital
🇮🇳
Kolkata, WEST BENGAL, India
Medicare Hospital
🇮🇳
Thane, MAHARASHTRA, India
Meera Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Popular Hospital
🇮🇳
Varanasi, UTTAR PRADESH, India
Shree Vrajesh Surgical Hospital
🇮🇳
Ahmadabad, GUJARAT, India
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Andhra Medical College, King George Hospital
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
Dr Naga Babu
Principal investigator
9849652094
tvssnagababu@gmail.com