Anal Fissure
Conditions
Interventions
This is a phase III study
it will involve more than one clinical center
single-blind, where the investigator and the team of doctors delegated by him, responsible for the clinical evaluation of the complete epithelialization of the chronic perianal fissure, will not be in
where the experimental arm and the comparator occur simultaneously, randomized, to evaluate the superiority of the efficacy and safety of the fixed-dose combination of 2% diltiazem hydrochloride and 2
D26.255.165.320
D26.909
Sponsors
Irmandade da Santa Casa de Misericórdia de Santos
Laboratórios Ferring LTDA.
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants capable of reading, or following along with the reading, understanding, and signing the informed consent form approved by the research ethics committee system; of both sexes; aged 18 years or older; capable of adequately communicating with the investigator and the clinical study team; diagnosed with chronic anal fissure; female participants without the potential to become pregnant; agree to use a safe contraceptive method; agree not to have anal intercourse during the study period
Exclusion criteria
Exclusion criteria: Participants diagnosed with malignant disease in the last 5 years, except for successfully treated basal cell carcinoma; those with chronic diseases on regular medication that, at the investigator’s discretion, may interfere with the clinical study; participants who show hypersensitivity or contraindication to any of the components of the formulations; female participants who are breastfeeding, planning to become pregnant, or who test positive for pregnancy during the study period; any clinical observation (clinical/physical evaluation) that is interpreted by the investigator as a risk to participation in the clinical study; participants who refuse to undergo visual or medical examination of the anal fissure; participants with more than one anal fissure; participants with anal fissure associated with or caused by other conditions, including but not limited to: drug-induced, trauma, human immunodeficiency virus (HIV) infection, anal fistula, inflammatory bowel disease, perianal sepsis, or malignancy; participants who refuse to discontinue all other concomitant topical preparations applied in and around the anus from the day before the start until the end of the clinical study; use of sitz baths from the signing of the informed consent form (ICF) until the end of the clinical study; use of anesthetics from the signing of the ICF until the end of the clinical study; injection of botulinum toxin into the anal fissure within 3 months prior to signing the ICF; participants actively treated with antiviral therapies for HIV (e.g., indinavir, nelfinavir, ritonavir); participants treated with any prohibited medication within 14 days prior to signing the ICF such as: cytochrome P450 (CYP450) inhibitors and inducers; cytochrome P3A4 (CYP3A4) substrates, inhibitors, and inducers; benzodiazepines; ß-adrenoceptor antagonists (Beta-Blockers); calcium channel blockers; digoxin; opioids; participants with any of the following concomitant conditions: sick sinus syndrome, except in the presence of a functioning ventricular pacemaker; second or third-degree atrioventricular block, except in the presence of a functioning ventricular pacemaker; hypotension (systolic pressure less than 90 mmHg); history of reduced left ventricular function, bradycardia, first-degree atrioventricular block, or prolonged PR interval (> 0.2 seconds / > 200 milliseconds) on electrocardiogram; documented acute myocardial infarction and pulmonary congestion by radiography; history of active uncontrolled diabetes and/or hypertension; current infection treated with a macrolide antibiotic; clinical evidence or history of fecal incontinence; clinical evidence or history of chronic constipation or constipation in the 4 weeks prior to signing the ICF (defined as 2 or fewer bowel movements per week; associated with straining/passage of hard stools); clinical evidence or history of anal fistula; clinical evidence or history of anal abscess; clinical evidence or history of fixed anal fibrosis; history of inflammatory bowel disease or active gastrointestinal disorders (e.g., inflammatory bowel disease, Crohn’s disease, ulcerative colitis); history of any previous anal or rectal surgery, including but not limited to: lateral sphincterotomy and anal dilation or other previous surgery involving the anal canal or perianal region; history of pelvic radiotherapy; participants with associated acute hemorrhoidal crises; participants with anal or perianal cancer; participants with a history of cardiac
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the time to complete epithelialization of chronic perianal fissure by visual inspectionon both arms, over 8 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the following pharmacokinetics parameters as from the plasma quantification of diltiazem hydrochloride and lidocaine hydrochloride in blood samples collected at pre-determined times: Percentage of the area under the extrapolated curve; Area under the plasma concentration versus time curve from time zero to the last time point measured; Area under the plasma concentration versus time curve from time zero to infinity; maximum plasma concentration; Time to reach maximum plasma concentration; Elimination half-life time; Elimination constant and Average residence time;Evaluatre change in the percentage of epithelialization of the perianal fissure by comparative photographic analysis of the fissure area between arms, recorded at the baseline visit and after 2, 4, 6, and 8 weeks of treatment;Evaluate change in pain severity after defecation as measured by the 11-point numerical rating scale for pain between arms at the baseline visit and after 2, 4, 6, and 8 weeks of treatment;Evaluate change in bleeding level after defecation as measured by the 3-point scale between arms at the baseline visit and after 2, 4, 6, and 8 weeks of treatment;Evaluate change in the effect of therapies on complete epithelialization of chronic perianal fissure by visual inspection between arms over specific time periods (2, 4, 6, and 8 weeks);Evaluate the occurrence rate of non-serious and serious adverse events, related and unrelated to treatment arms throughout the clinical study, based on database analysis obtained in clinical and physical assessments, laboratory tests, and clinical study-specific assessments;Evaluate the occurrence rate of adverse events of special interest between arms to be evaluated after 2, 4, 6, and 8 weeks of treatment, namely: Headache; Dizziness; Hypotension; Nausea/vomiting | — |
Countries
Brazil
Contacts
Public ContactRenato Faro
Laboratórios Ferring LTDA.
Outcome results
None listed