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

NCT ID: NCT05348200

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-22
• Study Completion Date: 2023-05-17

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.

Conditions

Hemorrhoids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Monad 1 cream

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

Group Type: ACTIVE_COMPARATOR

Monad 1

Intervention Type: DRUG

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

Monad 2 cream

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

Group Type: ACTIVE_COMPARATOR

Monad 2

Intervention Type: DRUG

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

Monad 3 cream

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

Group Type: ACTIVE_COMPARATOR

Monad 3

Intervention Type: DRUG

Single therapy cream containing Halobetasol Propionate (high strength).

Combination-CITI-002 (low dose) cream

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

Group Type: EXPERIMENTAL

Combination - CITI-002 (low dose)

Intervention Type: DRUG

Combination cream containing Lidocaine and HBP (low)

Combination-CITI-002 (high dose) cream

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

Group Type: EXPERIMENTAL

Combination - CITI-002 (high dose)

Intervention Type: DRUG

Combination cream containing Lidocaine and HBP (high)

Interventions

Monad 1

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

Intervention Type: DRUG

Monad 2

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

Intervention Type: DRUG

Monad 3

Single therapy cream containing Halobetasol Propionate (high strength).

Intervention Type: DRUG

Combination - CITI-002 (low dose)

Combination cream containing Lidocaine and HBP (low)

Intervention Type: DRUG

Combination - CITI-002 (high dose)

Combination cream containing Lidocaine and HBP (high)

Intervention Type: DRUG

Other Intervention Names

Lidocaine; Halobetasol Propionate (HBP); Halobetasol Propionate; CITI-002 L; CITI-002 H

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Therapeutics, Inc.

INDUSTRY

Sponsor Role: collaborator

Citius Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alan Lader, PhD

Role: PRINCIPAL_INVESTIGATOR

Citius Pharmaceuticals, Inc.

Locations

Site #01

Huntsville, Alabama, United States

Site #07

Tucson, Arizona, United States

Site #06

Chula Vista, California, United States

Site #09

Pomona, California, United States

Site #16

San Diego, California, United States

Site #03

San Diego, California, United States

Site #05

West Palm Beach, Florida, United States

Site #10

Covington, Louisiana, United States

Site #12

Prairieville, Louisiana, United States

Site #02

Wyoming, Michigan, United States

Site #14

Gulfport, Mississippi, United States

Site #08

Omaha, Nebraska, United States

Site #11

Mentor, Ohio, United States

Site #13

Tulsa, Oklahoma, United States

Site #04

Harrisburg, Pennsylvania, United States

Site #15

McKinney, Texas, United States

Countries

United States

Other Identifiers

143-11351-202

Identifier Type: -

Identifier Source: org_study_id