Combination - CITI-002 (low dose) for Hemorrhoids

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Site #13, Tulsa, OK
Hemorrhoids
Combination - CITI-002 (low dose) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial aims to find out if a cream is safe and effective for treating people with moderate to severe hemorrhoids. The drug combination CITI-002 (low dose) is being studied for its ability to treat hemorrhoids. This is a new use for the drug, which has previously been approved by the FDA for a different condition. Because the drug has already been approved for another condition, there is no need for a placebo group in this trial.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Day 8

Day 8
Change in Hemorrhoid symptoms
Change in Hemorrhoidal bother.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

5 Treatment Groups

Monad 1 cream
1 of 5
Monad 2 cream
1 of 5
Monad 3 cream
1 of 5
Combination-CITI-002 (high dose) cream
1 of 5
Combination-CITI-002 (low dose) cream
1 of 5
Active Control
Experimental Treatment

300 Total Participants · 5 Treatment Groups

Primary Treatment: Combination - CITI-002 (low dose) · No Placebo Group · Phase 2

Combination-CITI-002 (high dose) cream
Drug
Experimental Group · 1 Intervention: Combination - CITI-002 (high dose) · Intervention Types: Drug
Combination-CITI-002 (low dose) cream
Drug
Experimental Group · 1 Intervention: Combination - CITI-002 (low dose) · Intervention Types: Drug
Monad 1 cream
Drug
ActiveComparator Group · 1 Intervention: Monad 1 · Intervention Types: Drug
Monad 2 cream
Drug
ActiveComparator Group · 1 Intervention: Monad 2 · Intervention Types: Drug
Monad 3 cream
Drug
ActiveComparator Group · 1 Intervention: Monad 3 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 8
Closest Location: Site #13 · Tulsa, OK
Photo of oklahoma 1Photo of oklahoma 2Photo of oklahoma 3
2022First Recorded Clinical Trial
1 TrialsResearching Hemorrhoids
2 CompletedClinical Trials

Who is running the clinical trial?

Therapeutics, Inc.Industry Sponsor
27 Previous Clinical Trials
3,496 Total Patients Enrolled
Citius Pharmaceuticals, Inc.Lead Sponsor
1 Previous Clinical Trials
211 Total Patients Enrolled
1 Trials studying Hemorrhoids
211 Patients Enrolled for Hemorrhoids
Alan Lader, PhDPrincipal InvestigatorCitius Pharmaceuticals

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a clinical diagnosis of symptomatic hemorrhoids that are treatable without surgical intervention.
You have access to a device capable of communicating and interacting with the daily data collection application.
You are 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.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.