Status and phase
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About
The purpose of this study is to determine if the study drug, VEN307 (diltiazem hydrochloride cream) is safe and to see if it will help with treatment of pain associated with anal fissures.
Full description
Primary Objective:
To evaluate the efficacy of diltiazem hydrochloride cream on reduction of worst anal fissure (AF)-related pain associated with or following defecation when administered three times a day (TID) for 28 days.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Unwilling to have visual or medical examination of the AF.
More than 1 AF.
Subjects with AF associated with or caused by other conditions, including but not limited to: drug-induced, trauma, HIV infection, fistula-in-ano, inflammatory bowel disease, perianal sepsis or malignancy.
Unwilling to stop all other concomitant topical preparations applied in and around the anus from signing of ICF through Day 29 of the study.
Use of glyceryl trinitrate (GTN) ointment for 7 days (continuous or not) in the 28 days prior to signing the ICF.
Unwilling to discontinue use of sitz baths for up to 4 hours after each application of investigational product from signing of ICF to end of study.
Unwilling to discontinue use of anesthetics from signing the ICF to end of study.
Subfissure injection of botulinum toxin in the 3 months prior to signing the ICF.
Known sensitivity to investigational product(s) or calcium channel blockers.
Previous treatment with diltiazem hydrochloride cream or any other topical calcium channel blockers.
Active treatment with anti-viral therapies for HIV (e.g. indinavir, nelfinivir, ritonavir).
Treatment with any of the following medications within 14 days prior to signing the ICF:
Following concomitant disease state:
History of radiation therapy to the pelvis.
Fixed anal stenosis/fibrosis.
Major organ transplant.
Any clinically significant laboratory abnormalities during screening per investigator judgment.
Body Mass Index (BMI) > 40 kg/m2
Malignancy within 5 years prior to randomization (with the exception of treated basal cell/squamous cell carcinoma of the skin).
Any disease or prior/planned surgery that may interfere with the subject successfully completing the study.
Currently using narcotic(s).
Breast-feeding females.
Employees, family members, or students of the investigator or clinical site.
Primary purpose
Allocation
Interventional model
Masking
434 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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