Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT02689856
Brief Summary:
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.
Detailed Description:
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:
NCT02689856
Study Brief:
Protocol Section:
NCT02689856