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

NCT05348200 | Completed Phase 2 FDA Drug

• 1 other identifier: 143-11351-202
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 16

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.

Conditions

Hemorrhoids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Hemorrhoidal bother.

  Day 8

Study Arms (5)

Monad 1 cream

ACTIVE COMPARATOR

Topical cream applied to the peri-anal area twice daily for seven days.

Drug: Monad 1

Monad 2 cream

ACTIVE COMPARATOR

Topical cream applied to the peri-anal area twice daily for seven days.

Drug: Monad 2

Monad 3 cream

ACTIVE COMPARATOR

Topical cream applied to the peri-anal area twice daily for seven days.

Drug: Monad 3

Combination-CITI-002 (low dose) cream

EXPERIMENTAL

Topical cream applied to the peri-anal area twice daily for seven days.

Drug: Combination - CITI-002 (low dose)

Combination-CITI-002 (high dose) cream

EXPERIMENTAL

Topical cream applied to the peri-anal area twice daily for seven days.

Drug: Combination - CITI-002 (high dose)

Interventions

Monad 1 DRUG

Single therapy cream containing Lidocaine. Lidocaine is a topical anesthetic.

Also known as: Lidocaine

Monad 1 cream

Monad 2 DRUG

Single therapy cream containing Halobetasol Propionate (low-strength). HPB is a topical corticosteroid.

Also known as: Halobetasol Propionate (HBP)

Monad 2 cream

Monad 3 DRUG

Single therapy cream containing Halobetasol Propionate (high strength).

Also known as: Halobetasol Propionate

Monad 3 cream

Combination - CITI-002 (low dose) DRUG

Combination cream containing Lidocaine and HBP (low)

Also known as: CITI-002 L

Combination-CITI-002 (low dose) cream

Combination - CITI-002 (high dose) DRUG

Combination cream containing Lidocaine and HBP (high)

Also known as: CITI-002 H

Combination-CITI-002 (high dose) cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Citius Pharmaceuticals, Inc.: lead
• Therapeutics, Inc.: collaborator

Study Sites (16)

Site #01

Huntsville, Alabama, 35801, United States

Location

Site #07

Tucson, Arizona, 85715, United States

Location

Site #06

Chula Vista, California, 91910, United States

Location

Site #09

Pomona, California, 91767, United States

Location

Site #16

San Diego, California, 92103, United States

Location

Site #03

San Diego, California, 92123, United States

Location

Site #05

West Palm Beach, Florida, 33409, United States

Location

Site #10

Covington, Louisiana, 70433, United States

Location

Site #12

Prairieville, Louisiana, 70769, United States

Location

Site #02

Wyoming, Michigan, 49519, United States

Location

Site #14

Gulfport, Mississippi, 39503, United States

Location

Site #08

Omaha, Nebraska, 68114, United States

Location

Site #11

Mentor, Ohio, 44060, United States

Location

Site #13

Tulsa, Oklahoma, 74133, United States

Location

Site #04

Harrisburg, Pennsylvania, 17110, United States

Location

Site #15

McKinney, Texas, 75070, United States

Location

MeSH Terms

Conditions

Hemorrhoids

Interventions

Lidocaine; halobetasol

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Alan Lader, PhD

  Citius Pharmaceuticals, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized in one of the 5 Treatment Groups in a 1:1:1:1:1 ratio.

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 27, 2022
• Study Start: April 22, 2022
• Primary Completion: April 20, 2023
• Study Completion: May 17, 2023
• Last Updated: August 31, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)