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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
No Placebo-Only Group

Summary

This trial tests a special cream called CITI-002 for adults with moderate to severe hemorrhoids. The cream is applied regularly for a short period. Researchers want to see if it helps reduce pain and swelling. They will check patients' progress through surveys and regular visits.

Eligible Conditions
  • 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Hemorrhoid symptoms
Secondary study objectives
Change in Hemorrhoidal bother.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

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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
~85 spots leftby Dec 2025
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