Clinical Study to Evaluate the Efficacy andSafety of Fixed Dose Combination for treatment of Anal Fissure.
- Conditions
- Health Condition 1: K602- Anal fissure, unspecified
- Registration Number
- CTRI/2021/02/030971
- Lead Sponsor
- Abbott India Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 326
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
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
Investigatorââ?¬•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 groupTimepoint: from baseline (prior to application) to Day 10
- Secondary Outcome Measures
Name Time Method