Clinical trial NCT05348200: Safety and Efficacy of CITI-002 in Adult Patients With Moderate Grade Hemorrhoids
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hemorrhoids
Lead sponsor: Citius Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Therapeutics, Inc.
First posted: 2022-04-27
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized in one of the 5 Treatment Groups in a 1:1:1:1:1 ratio.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Hemorrhoid symptoms
timeFrame: Day 8
Secondary outcomes:
measure: Change in Hemorrhoidal bother.
timeFrame: Day 8
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Site #01
state: Alabama
city: Tucson
country: United States
facility: Site #07
state: Arizona
city: Chula Vista
country: United States
facility: Site #06
state: California
city: Pomona
country: United States
facility: Site #09
state: California
city: San Diego
country: United States
facility: Site #16
state: California
city: San Diego
country: United States
facility: Site #03
state: California
city: West Palm Beach
country: United States
facility: Site #05
state: Florida
city: Covington
country: United States
facility: Site #10
state: Louisiana
city: Prairieville
country: United States
facility: Site #12
state: Louisiana
city: Wyoming
country: United States
facility: Site #02
state: Michigan
city: Gulfport
country: United States
facility: Site #14
state: Mississippi
city: Omaha
country: United States
facility: Site #08
state: Nebraska
city: Mentor
country: United States
facility: Site #11
state: Ohio
city: Tulsa
country: United States
facility: Site #13
state: Oklahoma
city: Harrisburg
country: United States
facility: Site #04
state: Pennsylvania
city: McKinney
country: United States
facility: Site #15
state: Texas
Study officials:
affiliation: Citius Pharmaceuticals, Inc.
name: Alan Lader, PhD
role: PRINCIPAL_INVESTIGATOR
References: