NCT02689856

Safety and Efficacy of Hydrocortisone and Lidocaine Treatment of Grade I and II Hemorrhoids

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: Citius Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemorrhoids

Interventions

Type	Name	Description
DRUG	Hydrocortisone acetate and lidocaine hydrochloride	Hydrocortisone and lidocaine in combination
DRUG	Placebo control	Vehicle cream alone
DRUG	Hydrocortisone acetate	hydrocortisone alone
DRUG	Lidocaine hydrochloride	lidocaine alone

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-09-01
• Completion: 2015-10-01
• First posted: 2016-02-24
• Last updated: 2016-02-24