Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-01 @ 12:22 AM
Study NCT ID:
NCT02689856
Status:
COMPLETED
Last Update Posted:
2016-02-24
First Post:
2016-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Hydrocortisone and Lidocaine Treatment of Grade I and II Hemorrhoids
Sponsor:
Citius Pharmaceuticals, Inc.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Hydro/Lido
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: