Health Condition 1: K602- Anal fissure, unspecified
Conditions
Interventions
Intervention1: 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
Sponsors
Abbott India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Mean reduction in anal pain intensity (on 100 mm VAS)Timepoint: 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;Mean reduction in anal pain intensity (on 100 mm VAS)within test group and reference groupTimepoint: from baseline (prior to application) to Day 10;Mean time to complete healing of anal fissureTimepoint: Day 1 to Day 40;Number of rescue medication (Diclofenac 50 mg) tablets and the average daily dose taken by a patientTimepoint: 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- point scale ranging from ââ?¬Å?score 1ââ?¬? (no relief) to ââ?¬Å?score 5ââ?¬? (complete relief)Timepoint: Day 1 (0.5 hour, 1 hour, 2 hours, 4 hours, and 8 hours after first application);Patient and Investigator global assessment of treatmentTimepoint: at Day 5, Day 10, Day 25, and Day 40;Proportion of patients with partial / complete healing of anal fissureTimepoint: At Day 5, Day10, Day 25, and Day 40;Reduction in itching (on a 5-point scale) and bleeding (recorded as peri-anal bleeding score)Timepoint: From baseline (prior to application) to Day 5, Day 10, Day 25, and Day 40 | — |
Countries
India
Contacts
Public ContactDr Shivani Acharya
Abbott India Limited
Outcome results
None listed