Hemorrhoids Clinical Trial
Official title:
A Randomized, Dose-Ranging, Double Blind Study of Lidocaine Hydrochloride and/or Hydrocortisone Acetate (Alone or in Combination) in the 14-Day Twice-Daily Treatment of Grade I or II Hemorrhoids
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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