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Combination - CITI-002 (low dose) for Hemorrhoids

Phase 2
Waitlist Available
Led By Alan Lader, PhD
Research Sponsored by Citius Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 8
Awards & highlights

Study Summary

This trial aims to find out if a cream is safe and effective for treating people with moderate to severe hemorrhoids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Hemorrhoid symptoms
Secondary outcome measures
Change in Hemorrhoidal bother.

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Combination-CITI-002 (low dose) creamExperimental Treatment1 Intervention
Topical cream applied to the peri-anal area twice daily for seven days.
Group II: Combination-CITI-002 (high dose) creamExperimental Treatment1 Intervention
Topical cream applied to the peri-anal area twice daily for seven days.
Group III: Monad 1 creamActive Control1 Intervention
Topical cream applied to the peri-anal area twice daily for seven days.
Group IV: Monad 2 creamActive Control1 Intervention
Topical cream applied to the peri-anal area twice daily for seven days.
Group V: Monad 3 creamActive Control1 Intervention
Topical cream applied to the peri-anal area twice daily for seven days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Combination - CITI-002 (low dose)
2022
Completed Phase 2
~310
Combination - CITI-002 (high dose)
2022
Completed Phase 2
~310

Find a Location

Who is running the clinical trial?

Citius Pharmaceuticals, Inc.Lead Sponsor
1 Previous Clinical Trials
211 Total Patients Enrolled
1 Trials studying Hemorrhoids
211 Patients Enrolled for Hemorrhoids
Therapeutics, Inc.Industry Sponsor
30 Previous Clinical Trials
3,608 Total Patients Enrolled
Alan Lader, PhDPrincipal InvestigatorCitius Pharmaceuticals

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open for this experiment at the present time?

"Affirmative. According to information posted on clinicaltrials.gov, this experiment is currently open for enrollment and was initially published on April 22nd 2022 before being revised lastly on April 28th. The study necessitates the recruitment of 300 patients from 16 separate locations."

Answered by AI

How many facilities are currently participating in this experimental trial?

"This trial requires patients from 16 distinct sites, including Huntsville's Site #01, Chula Vista's Site #06, and Pomona's Site #09."

Answered by AI

Has this distinct formulation of CITI-002 (low dose) been accepted by the FDA?

"Combination - CITI-002 (low dose) was given a rating of 2 as this is an experimental stage two trial, where limited safety data exists but no evidence of efficacy has yet been reported."

Answered by AI

How many individuals have been recruited for participation in this clinical experiment?

"A total of 300 participants, conforming to the specified inclusion criteria, are necessary for this study. Patients can enroll at various trial sites including Huntsville (Alabama) and Chula Vista (California)."

Answered by AI

Who else is applying?

What state do they live in?
Oklahoma
Other
Texas
Nebraska
How old are they?
18 - 65
What site did they apply to?
Site #03
Site #08
Site #15
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I don’t want another hemorrhoidectomy. I'm tired of having hemorrhoids and have no medication to treat them.
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. Site #15: < 48 hours
Typically responds via
Phone Call
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of CITI-002 in Adult Patients With Moderate Grade Hemorrhoids
2022. "Safety and Efficacy of CITI-002 in Adult Patients With Moderate Grade Hemorrhoids". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05348200.
~101 spots leftby Apr 2025
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