Safety and Efficacy of CITI-002 in Adult Patients With Moderate Grade Hemorrhoids

Hemorrhoids Clinical Trial

Official title:

A Randomized, Dose-Ranging, Double Blind Study to Demonstrate the Safety and Efficacy of a CITI-002 Cream in the Seven Day Twice-Daily Treatment of Grade II or III Hemorrhoids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05348200
• Other study ID #: 143-11351-202
• Status: Completed
• Phase: Phase 2
• Start date: April 22, 2022
• Est. completion date: May 17, 2023

Study information

• Verified date: April 2022
• Source: Citius Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Randomized Phase 2 double blind study which aims to determine the safety and efficacy of CITI-002 cream in adult patients with Goligher's grade II or III hemorrhoids.

Description:

This Phase 2 study aims to compare the safety and efficacy of 5 different treatment groups. The study drug will be applied twice daily for 7 days. Response to the study drug will be measured through patient responses to an electronic Patient Reported Outcome (ePRO). There are 4 study visits: first visit is screening (day 1), follow-up visit (day 5), end of treatment (day 8), and end of study visit (day 15). There will also be one telephone visit on day 2. This study will be done in ~16 US sites and about 300 subjects will be enrolled.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: May 17, 2023
• Est. primary completion date: April 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or non-pregnant female 18 years of age or older.
• Signs written informed consent for the study.
• Females must be post-menopausal , surgically sterile , or use an effective method of birth control, or women of childbearing potential (WOCBP) must have a negative Urine Pregnancy Test (UPT).
• Clinical diagnosis of confirmed symptomatic Goligher's classification Grade II or III hemorrhoids that are treatable without surgical intervention.
• Has an active "flare up" of hemorrhoids .
• Willing and able to apply the test article as directed, comply with study instructions, read, understand, and complete required questionnaires in English, and commit to all follow-up visits for the duration of the study.
• In good general health and free of any disease state or physical condition that might impair evaluation of hemorrhoids or exposes the subject to an unacceptable risk by study participation.
• If using stool softeners and/or fiber supplementation, must be on a stable regimen for at least 4 days prior to enrolling in the study and agree to remain on the stable regimen while in the study.
• Free of Coronavirus Disease (COVID) related signs and symptoms and if unvaccinated has no known close exposure to any person with COVID 10 days prior to enrolling in the study.
• Has access to device capable of communicating and interacting with daily data collection application (e.g., a smart phone capable of running the data collection application)

Exclusion Criteria:

• Has Grade I hemorrhoids; Grade III hemorrhoids that require surgical intervention; or Grade IV hemorrhoids.
• Females who are pregnant, lactating, or is planning to become pregnant during the study.
• Has anorectal condition(s) such as malignant tumors of the anus or rectum, fistula-in-ano or chronic sepsis, fissure(s), incontinence, or condylomata.
• Has a history of previous proctological surgery or has active inflammatory bowel disease.
• Used the following systemic, oral, or topical therapies for the periods specified

prior to enrolling into the study:

1. Within 1 day: topical application of any kind to the rectal/peri-anal area.

2. Within 4 days: prescription (including topical steroids), over-the-counter (OTC), homeopathic, or home remedy treatments, including but not limited to, oral formulations, cream, ointment, gel, foam, sitz baths, wipes, or liquids labeled or intended for the treatment of hemorrhoids that could have a significant effect on the disease in the opinion of the investigator.

• If currently using aspirin (excluding low-dose for prophylaxis), has an uncorrected coagulation defect, or concurrently uses anticoagulants (except non-steroidals).
• Used systemic corticosteroids or narcotics within 4 weeks prior to Visit 1/Baseline.
• Currently enrolled in an investigational drug, biologic, or device study.
• Has used an investigational drug, investigational biologic, or investigational device treatment within 30 days prior to first application of the test article.
• History of sensitivity to any of the ingredients in the test articles.
• Has Addison's Disease, Cushing's Syndrome, or impaired Hypothalamic-Pituitary-Adrenal (HPA) axis function.

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

Drug:
• Monad 1
Single therapy cream containing Lidocaine. Lidocaine is a topical anesthetic.
• Monad 2
Single therapy cream containing Halobetasol Propionate (low-strength). HPB is a topical corticosteroid.
• Monad 3
Single therapy cream containing Halobetasol Propionate (high strength).
• Combination - CITI-002 (low dose)
Combination cream containing Lidocaine and HBP (low)
• Combination - CITI-002 (high dose)
Combination cream containing Lidocaine and HBP (high)

Locations

Country	Name	City	State
United States	Site #06	Chula Vista	California
United States	Site #10	Covington	Louisiana
United States	Site #14	Gulfport	Mississippi
United States	Site #04	Harrisburg	Pennsylvania
United States	Site #01	Huntsville	Alabama
United States	Site #15	McKinney	Texas
United States	Site #11	Mentor	Ohio
United States	Site #08	Omaha	Nebraska
United States	Site #09	Pomona	California
United States	Site #12	Prairieville	Louisiana
United States	Site #03	San Diego	California
United States	Site #16	San Diego	California
United States	Site #07	Tucson	Arizona
United States	Site #13	Tulsa	Oklahoma
United States	Site #05	West Palm Beach	Florida
United States	Site #02	Wyoming	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Citius Pharmaceuticals, Inc.	Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemorrhoid symptoms	Change in hemorrhoidal symptoms (pain, burning, itching, and swelling) as measured by the patient using a numeric rating scale.	Day 8
Secondary	Change in Hemorrhoidal bother.	Change of hemorrhoidal symptoms related to bowel movement interference and pressure as measured by the patient using a numeric rating scale.	Day 8