HemorrhoidsPhase 2NCT05348200
Safety and Efficacy of CITI-002 in Adult Patients With Moderate Grade Hemorrhoids
A Phase 2 study testing Monad 1, Monad 2 and Monad 3 in people with Hemorrhoids, run by Citius Pharmaceuticals, Inc. at 16 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- Monad 1, Monad 2 and Monad 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 16 sitesUnited States
- Study dates
- 22 Apr 2022to 17 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Site #06
Chula Vista, California, 91910
Site #10
Covington, Louisiana, 70433
Site #14
Gulfport, Mississippi, 39503
Site #04
Harrisburg, Pennsylvania, 17110
Site #01
Huntsville, Alabama, 35801
Site #15
McKinney, Texas, 75070
Site #11
Mentor, Ohio, 44060
Site #08
Omaha, Nebraska, 68114
Site #09
Pomona, California, 91767
Site #12
Prairieville, Louisiana, 70769
Site #16
San Diego, California, 92103
Site #03
San Diego, California, 92123
Site #07
Tucson, Arizona, 85715
Site #13
Tulsa, Oklahoma, 74133
Site #05
West Palm Beach, Florida, 33409
Site #02
Wyoming, Michigan, 49519
About this study
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
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.
Read the 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
- Being tested
- Monad 1, Monad 2, Monad 3, Combination - CITI-002 (low dose), Combination - CITI-002 (high dose)
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monad 1Drug
Also called Lidocaine
Single therapy cream containing Lidocaine. Lidocaine is a topical anesthetic.
Monad 2Drug
Also called Halobetasol Propionate (HBP)
Single therapy cream containing Halobetasol Propionate (low-strength). HPB is a topical corticosteroid.
Monad 3Drug
Also called Halobetasol Propionate
Single therapy cream containing Halobetasol Propionate (high strength).
Combination - CITI-002 (low dose)Drug
Also called CITI-002 L
Combination cream containing Lidocaine and HBP (low)
Combination - CITI-002 (high dose)Drug
Also called CITI-002 H
Combination cream containing Lidocaine and HBP (high)
| Study group | Role | What they receive |
|---|---|---|
| Monad 1 cream | Active comparator | Topical cream applied to the peri-anal area twice daily for seven days. Receives: Drug: Monad 1 |
| Monad 2 cream | Active comparator | Topical cream applied to the peri-anal area twice daily for seven days. Receives: Drug: Monad 2 |
| Monad 3 cream | Active comparator | Topical cream applied to the peri-anal area twice daily for seven days. Receives: Drug: Monad 3 |
| Combination-CITI-002 (low dose) cream | Experimental | Topical cream applied to the peri-anal area twice daily for seven days. Receives: 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. Receives: Drug: Combination - CITI-002 (high dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemorrhoid symptoms
Change in hemorrhoidal symptoms (pain, burning, itching, and swelling) as measured by the patient using a numeric rating scale.
Measured: Day 8
Secondary outcomes (1)
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.
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start22 Apr 2022
- Primary completion20 Apr 2023
- Study completion17 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized in one of the 5 Treatment Groups in a 1:1:1:1:1 ratio.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Citius Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Alan Lader, PhD, Principal investigator, Citius Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348200
- Sponsor's protocol ID
- 143-11351-202
- Status last verified
- Apr 2022
- First submitted
- 21 Apr 2022
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05348200
- Acronym / sponsor ID
- 143-11351-202
- Conditions
- Hemorrhoids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Citius Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Therapeutics, Inc.
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
- Model description
- Subjects will be randomized in one of the 5 Treatment Groups in a 1:1:1:1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Monad 1 cream | Active comparator | Drug: Monad 1Topical cream applied to the peri-anal area twice daily for seven days. |
| Monad 2 cream | Active comparator | Drug: Monad 2Topical cream applied to the peri-anal area twice daily for seven days. |
| Monad 3 cream | Active comparator | Drug: Monad 3Topical cream applied to the peri-anal area twice daily for seven days. |
| Combination-CITI-002 (low dose) cream | Experimental | Drug: Combination - CITI-002 (low dose)Topical cream applied to the peri-anal area twice daily for seven days. |
| Combination-CITI-002 (high dose) cream | Experimental | Drug: Combination - CITI-002 (high dose)Topical cream applied to the peri-anal area twice daily for seven days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 .
Key exclusion criteria (13 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monad 1Also: LidocaineSingle therapy cream containing Lidocaine. Lidocaine is a topical anesthetic. | Drug | Monad 1 cream |
| Monad 2Also: Halobetasol Propionate (HBP)Single therapy cream containing Halobetasol Propionate (low-strength). HPB is a topical corticosteroid. | Drug | Monad 2 cream |
| Monad 3Also: Halobetasol PropionateSingle therapy cream containing Halobetasol Propionate (high strength). | Drug | Monad 3 cream |
| Combination - CITI-002 (low dose)Also: CITI-002 LCombination cream containing Lidocaine and HBP (low) | Drug | Combination-CITI-002 (low dose) cream |
| Combination - CITI-002 (high dose)Also: CITI-002 HCombination cream containing Lidocaine and HBP (high) | Drug | Combination-CITI-002 (high dose) cream |
Primary outcome
Change in Hemorrhoid symptoms
Time frame: Day 8
Change in hemorrhoidal symptoms (pain, burning, itching, and swelling) as measured by the patient using a numeric rating scale.
1 secondary outcome
Change in Hemorrhoidal bother.
Time frame: Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Lader, PhD principal investigator
Citius Pharmaceuticals, Inc.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Monad 1, Monad 2 and Monad 3 in people with Hemorrhoids, run by Citius Pharmaceuticals, Inc. at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemorrhoid symptoms (time frame: Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.