The objectives of this study are to assess the potential contribution of lidocaine hydrochloride or hydrocortisone acetate, alone or in combination, in topical cream preparations in the treatment of Grade I or II hemorrhoids and to demonstrate the safety and efficacy of the test articles when applied twice daily for 14 days in subjects with Grade I or II hemorrhoids. These products reflect common drug combinations of lidocaine hydrochloride or hydrocortisone acetate found in many prescription hemorrhoid products.
This is a multi-center, randomized, double-blind, parallel group comparison study in approximately 196 enrolled subjects (\~28 subjects/test article) at approximately eight (8) sites. A minimum of 147 patients will be enrolled. Up to an additional 56 subjects (up to 196 subjects) may be enrolled based on enrollment rates and availability of patients. Enrollment status reports will be periodically generated, and based on enrollment experience, additional randomization blocks will be assigned to sites with the potential to enroll additional subjects over a reasonable period of time. Male and female subjects, ages 18 years and older, with a clinical diagnosis of symptomatic Grade I or Grade II hemorrhoids will be randomized to treatment with one of seven (7) test articles (1:1 for all groups): 1. Vehicle Cream 2. 3% Hydrocortisone Acetate Cream 3. 0.5% Hydrocortisone Acetate Cream 4. 5% Lidocaine Hydrochloride Cream 5. 1% Lidocaine Hydrochloride Cream 6. 3% Hydrocortisone Acetate Cream and 5% Lidocaine Hydrochloride Cream 7. 0.5% Hydrocortisone Acetate Cream and 1% Lidocaine Hydrochloride Cream The test articles will be applied twice daily for two (2) weeks (14 days) to the peri-rectal area as well as the distal aspect of the anal canal using the product applicator tip.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
211
Hydrocortisone and lidocaine in combination
Vehicle cream alone
hydrocortisone alone
Global score of disease severity
A measure overall discomfort on a scale of 0 to 5
Time frame: up to 14 days
Individual signs and symptoms
Has the subject received relief of pain, itching, bleeding or other reported symptoms evaluated on a scale of 0 to 5.
Time frame: up to 14 days
Onset of relief of symptoms
How fast does the subject feel relief of symptoms measured in time after application of the drug.
Time frame: 4 hours following product administration
Recurrence of symptoms
When do the symptoms return measured in time after application of the drug.
Time frame: 4 hours following product administration
Severity and frequency of adverse events
Assessment of severity and frequency of adverse events.
Time frame: 14 days
Laboratory assessment
Assessment of changes in blood chemistry, hematology and urinalysis at day 14 compared to baseline.
Time frame: 14 days
Electrocardiography
Assessment of changes in ECG parameters at day 14 compared to baseline.
Time frame: 14 days
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lidocaine alone