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

NCT02689856 | Completed Phase 2

• 1 other identifier: 143-6151-201
• Study Type: interventional
• Target: 211
• Locations: 0 countries
• Sites: N/A

Brief 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

Hemorrhoids

Outcome Measures

Primary Outcomes (1)

• Global score of disease severity

  A measure overall discomfort on a scale of 0 to 5

  up to 14 days

Secondary Outcomes (6)

• Individual signs and symptoms

  up to 14 days

• Onset of relief of symptoms

  4 hours following product administration

• Recurrence of symptoms

  4 hours following product administration

• Severity and frequency of adverse events

  14 days

• Laboratory assessment

  14 days

Study Arms (7)

Vehicle cream

PLACEBO COMPARATOR

Placebo control base cream

Drug: Placebo control

3% hydrocortisone

EXPERIMENTAL

3% Hydrocortisone acetate cream

Drug: Hydrocortisone acetate

0.5% hydrocortisone

EXPERIMENTAL

0.5% Hydrocortisone acetate cream

Drug: Hydrocortisone acetate

5% lidocaine

EXPERIMENTAL

5% Lidocaine hydrochloride cream

Drug: Lidocaine hydrochloride

1% lidocaine

EXPERIMENTAL

1% Lidocaine hydrochloride cream

Drug: Lidocaine hydrochloride

3% Hydro 5% Lido

EXPERIMENTAL

Hydrocortisone acetate and lidocaine hydrochloride at 3% and 5% cream

Drug: Hydrocortisone acetate and lidocaine hydrochloride

0.5% Hydro 1% Lido

EXPERIMENTAL

Hydrocortisone acetate and lidocaine hydrochloride at 0.5% and 1% cream

Drug: Hydrocortisone acetate and lidocaine hydrochloride

Interventions

Hydrocortisone acetate and lidocaine hydrochloride DRUG

Hydrocortisone and lidocaine in combination

0.5% Hydro 1% Lido; 3% Hydro 5% Lido

Placebo control DRUG

Vehicle cream alone

Vehicle cream

Hydrocortisone acetate DRUG

hydrocortisone alone

0.5% hydrocortisone; 3% hydrocortisone

Lidocaine hydrochloride DRUG

lidocaine alone

1% lidocaine; 5% lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is male or non-pregnant female 18 years of age or older, in generally good health. Females must be post-menopausal, surgically sterile or have a negative urine pregnancy test (UPT) at the Baseline Visit and agree to use birth control during the study.
• Subject has provided written and verbal informed consent.
• Subject presents to the clinic with clinically confirmed symptomatic Grade I or II hemorrhoids (GSDS ≥ 2).
• Subject is willing and able to comply with study instructions and return to the clinic for required visits.

You may not qualify if:

• Subject is female and lactating or planning to become pregnant during the study.
• Subject has anorectal condition(s) such as malignant tumors of the anus or rectum, fistula-in-ano or chronic sepsis, fissure-in-ano, incontinence, condylomata and Grade III and IV hemorrhoids.
• Subject has a history of previous proctological surgery or has active inflammatory bowel disease.
• Subject may use stool softeners, but shall be on a stable regimen for at least 28 days prior to enrolling in the study.
• Subject used the following systemic, oral or topical therapies for the periods specified prior to entry into the study:
• Within 1 day: Topicals of any kind to the rectal/peri-rectal area.
• Within 1 week: Over the counter (OTC) or prescription treatments labeled or intended for the treatment of hemorrhoids or that could have a significant effect in the opinion of the investigator including but not limited to steroids, OTC and prescription hemorrhoid products, among others.
• Subject has a current history of an uncorrected coagulation defect or concurrently uses anticoagulants (except aspirin or non-steroidals).
• Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical, systemic or surgical therapy.
• Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles.
• Subject has any condition which, in the Investigator's opinion, would make it unsafe or preclude the subject's ability to fully participate in this research study.
• Subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, impaired cerebral function or physical limitations.
• Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
• Subject is currently enrolled in an investigational drug or device study.
• Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (Baseline).

Sponsors & Collaborators

• Citius Pharmaceuticals, Inc.: lead

MeSH Terms

Conditions

Hemorrhoids

Interventions

hydrocortisone acetate; Lidocaine

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Alan S. Lader, Ph.D.

  Citius Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: February 24, 2016
• Study Start: May 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 24, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share