MedTrace Logo

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

NCT05348200 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2023-08-31

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Monad 1

Single therapy cream containing Lidocaine. Lidocaine is a topical anesthetic.

DRUG

Monad 2

Single therapy cream containing Halobetasol Propionate (low-strength). HPB is a topical corticosteroid.

DRUG

Monad 3

Single therapy cream containing Halobetasol Propionate (high strength).

DRUG

Combination - CITI-002 (low dose)

Combination cream containing Lidocaine and HBP (low)

DRUG

Combination - CITI-002 (high dose)

Combination cream containing Lidocaine and HBP (high)

Sponsors & Collaborators

  • Therapeutics, Inc.

    collaborator INDUSTRY

  • Citius Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Alan Lader, PhD · Citius Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-22
Primary Completion
2023-04-20
Completion
2023-05-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05348200 on ClinicalTrials.gov