Comparison study to evaluate the efficacy and safety of a topical gel

Not Applicable

• Conditions: Health Condition 1: K602- Anal fissure, unspecified

• Registration Number: CTRI/2024/08/072002
• Lead Sponsor: Abbott India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Males and females with age 18 to 64 years (both inclusive) with a diagnosis of anal fissure

Willing to stop all other concomitant topical preparations applied peri-anally prior to commencing study treatment and throughout the study

Subjects who understand the requirement of the study and is willing to sign and date written informed consent to participate in the study

Exclusion Criteria

Subjects unwilling to have an examination of anal fissure

Subjects having anal fistulas or anal fissure of various causes such as Crohn disease anal suppuration abscesses

Subjects who have or have undergone the following gastrointestinal disorders or procedures Inflammatory bowel disease chronic fecal

incontinence anal abscess a history of radiation therapy to the pelvis fixed anal stenosis/fibrosis

Subjects with a history of neoplastic disease within 5 years

Subjects with associated acute hemorrhoidal attacks

Subjects having anal or perianal cancer

Subjects who have had lateral sphincterotomy or anal stretch or other previous surgery involving the anal canal or perianal region

Subjects with a clinically significant history of renal hepatic neurological dermatological immunological major psychiatric (including drug or alcohol abusers) or hematological illness

Subjects of hypertension / ischemic heart disease on oral calcium channel blockers

Subjects with atrial fibrillation associated with other conditions

Subjects with cardiovascular disease

Subjects who have previously received therapy with diltiazem hydrochloride cream nitrates vasodilator or other topical calcium channel blockers

Subjects with hypersensitivity to any of the ingredients in the study drug

Females of childbearing potential must have a negative pregnancy test and be non-lactating

Subjects 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