Health Condition 1: K602- Anal fissure, unspecified
Conditions
Interventions
Intervention1: CremaGel-L contains
Diltiazem hydrochloride 2% w/w + Lidocaine hydrochloride 2% w/w Gel: The test product has to applied thrice a day topically around the inner sides of the anal canal
Sponsors
Abbott India Limited
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of Diltiazem hydrochloride 2% w/w +Lidocaine hydrochloride 2% w/w Gel with Lignocaine Hydrochloride Gel 2% w/wTimepoint: Baseline Day 10 Day 21 | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the change in Mean Resting Anal Pressure of Anal Fissure Patients after applying Diltiazem hydrochloride 2% w/w + Lidocaine hydrochloride 2% w/w Gel with Lignocaine Hydrochloride Gel 2% w/w at 30 minutes on Day 1 and at Day 10 and Day 21 with baseline To evaluate the tolerability and safety of Diltiazem hydrochloride 2% w/w + Lidocaine hydrochloride 2% w/w Gel with Lignocaine Hydrochloride Gel 2% w/w during the study periodTimepoint: Day 1 Day 10 and Day 21 with baseline | — |
Countries
India
Contacts
Public ContactJawahar Nidamboor
Jyoti Nursing Home
Outcome results
None listed