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

Sponsor
Citius Pharmaceuticals, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05348200
Collaborator
Therapeutics, Inc. (Industry)
300
Enrollment
16
Locations
5
Arms
14.3
Anticipated Duration (Months)
18.8
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Monad 1
  • Drug: Monad 2
  • Drug: Monad 3
  • Drug: Combination - CITI-002 (low dose)
  • Drug: Combination - CITI-002 (high dose)
 Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Subjects will be randomized in one of the 5 Treatment Groups in a 1:1:1:1:1 ratio.Subjects will be randomized in one of the 5 Treatment Groups in a 1:1:1:1:1 ratio.
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 22, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Monad 1 cream

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

Drug: Monad 1
Single therapy cream containing Lidocaine. Lidocaine is a topical anesthetic.
Other Names:
  • Lidocaine

    		•
    Active Comparator: Monad 2 cream

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

    Drug: Monad 2
    Single therapy cream containing Halobetasol Propionate (low-strength). HPB is a topical corticosteroid.
    Other Names:
  • Halobetasol Propionate (HBP)

    		•
    Active Comparator: Monad 3 cream

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

    Drug: Monad 3
    Single therapy cream containing Halobetasol Propionate (high strength).
    Other Names:
  • Halobetasol Propionate

    		•
    Experimental: Combination-CITI-002 (low dose) cream

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

    Drug: Combination - CITI-002 (low dose)
    Combination cream containing Lidocaine and HBP (low)
    Other Names:
  • CITI-002 L

    		•
    Experimental: Combination-CITI-002 (high dose) cream

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

    Drug: Combination - CITI-002 (high dose)
    Combination cream containing Lidocaine and HBP (high)
    Other Names:
  • CITI-002 H

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Hemorrhoid symptoms [Day 8]

      Change in hemorrhoidal symptoms (pain, burning, itching, and swelling) as measured by the patient using a numeric rating scale.

    Secondary Outcome Measures

    1. Change in Hemorrhoidal bother. [Day 8]

      Change of hemorrhoidal symptoms related to bowel movement interference and pressure as measured by the patient using a numeric rating scale.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site #01 Huntsville Alabama United States 35801
    2 Site #07 Tucson Arizona United States 85715
    3 Site #06 Chula Vista California United States 91910
    4 Site #09 Pomona California United States 91767
    5 Site #16 San Diego California United States 92103
    6 Site #03 San Diego California United States 92123
    7 Site #05 West Palm Beach Florida United States 33409
    8 Site #10 Covington Louisiana United States 70433
    9 Site #12 Prairieville Louisiana United States 70769
    10 Site #02 Wyoming Michigan United States 49519
    11 Site #14 Gulfport Mississippi United States 39503
    12 Site #08 Omaha Nebraska United States 68114
    13 Site #11 Mentor Ohio United States 44060
    14 Site #13 Tulsa Oklahoma United States 74133
    15 Site #04 Harrisburg Pennsylvania United States 17110
    16 Site #15 McKinney Texas United States 75070

    Sponsors and Collaborators

    • Citius Pharmaceuticals, Inc.
    • Therapeutics, Inc.

    Investigators

    • Principal Investigator: Alan Lader, PhD, Citius Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Citius Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT05348200
    Other Study ID Numbers:
    • 143-11351-202
    First Posted:
    Apr 27, 2022
    Last Update Posted:
    May 4, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hemorrhoids
    Clobetasol
    Lidocaine
    Halobetasol

    Study Results

    No Results Posted as of May 4, 2022