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Safety and Efficacy of Hydrocortisone and Lidocaine Treatment of Grade I and II Hemorrhoids

NCT02689856 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2016-02-24

No results posted yet for this study

Summary

The objectives of this study are to assess the potential contribution of lidocaine hydrochloride or hydrocortisone acetate, alone or in combination, in topical cream preparations in the treatment of Grade I or II hemorrhoids and to demonstrate the safety and efficacy of the test articles when applied twice daily for 14 days in subjects with Grade I or II hemorrhoids. These products reflect common drug combinations of lidocaine hydrochloride or hydrocortisone acetate found in many prescription hemorrhoid products.

Conditions

Interventions

DRUG

Hydrocortisone acetate and lidocaine hydrochloride

Hydrocortisone and lidocaine in combination

DRUG

Placebo control

Vehicle cream alone

DRUG

Hydrocortisone acetate

hydrocortisone alone

DRUG

Lidocaine hydrochloride

lidocaine alone

Sponsors & Collaborators

  • Citius Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Alan S. Lader, Ph.D. · Citius Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-09-30
Completion
2015-10-31

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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 NCT02689856 on ClinicalTrials.gov