- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02689856
Safety and Efficacy of Hydrocortisone and Lidocaine Treatment of Grade I and II Hemorrhoids (Hydro/Lido)
A Randomized, Dose-Ranging, Double Blind Study of Lidocaine Hydrochloride and/or Hydrocortisone Acetate (Alone or in Combination) in the 14-Day Twice-Daily Treatment of Grade I or II Hemorrhoids
Study Overview
Status
Conditions
Detailed Description
This is a multi-center, randomized, double-blind, parallel group comparison study in approximately 196 enrolled subjects (~28 subjects/test article) at approximately eight (8) sites. A minimum of 147 patients will be enrolled. Up to an additional 56 subjects (up to 196 subjects) may be enrolled based on enrollment rates and availability of patients. Enrollment status reports will be periodically generated, and based on enrollment experience, additional randomization blocks will be assigned to sites with the potential to enroll additional subjects over a reasonable period of time.
Male and female subjects, ages 18 years and older, with a clinical diagnosis of symptomatic Grade I or Grade II hemorrhoids will be randomized to treatment with one of seven (7) test articles (1:1 for all groups):
- Vehicle Cream
- 3% Hydrocortisone Acetate Cream
- 0.5% Hydrocortisone Acetate Cream
- 5% Lidocaine Hydrochloride Cream
- 1% Lidocaine Hydrochloride Cream
- 3% Hydrocortisone Acetate Cream and 5% Lidocaine Hydrochloride Cream
- 0.5% Hydrocortisone Acetate Cream and 1% Lidocaine Hydrochloride Cream
The test articles will be applied twice daily for two (2) weeks (14 days) to the peri-rectal area as well as the distal aspect of the anal canal using the product applicator tip.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Vehicle cream
Placebo control base cream
|
Vehicle cream alone
|
Experimental: 3% hydrocortisone
3% Hydrocortisone acetate cream
|
hydrocortisone alone
|
Experimental: 0.5% hydrocortisone
0.5% Hydrocortisone acetate cream
|
hydrocortisone alone
|
Experimental: 5% lidocaine
5% Lidocaine hydrochloride cream
|
lidocaine alone
|
Experimental: 1% lidocaine
1% Lidocaine hydrochloride cream
|
lidocaine alone
|
Experimental: 3% Hydro 5% Lido
Hydrocortisone acetate and lidocaine hydrochloride at 3% and 5% cream
|
Hydrocortisone and lidocaine in combination
|
Experimental: 0.5% Hydro 1% Lido
Hydrocortisone acetate and lidocaine hydrochloride at 0.5% and 1% cream
|
Hydrocortisone and lidocaine in combination
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global score of disease severity
Time Frame: up to 14 days
|
A measure overall discomfort on a scale of 0 to 5
|
up to 14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Individual signs and symptoms
Time Frame: up to 14 days
|
Has the subject received relief of pain, itching, bleeding or other reported symptoms evaluated on a scale of 0 to 5.
|
up to 14 days
|
Onset of relief of symptoms
Time Frame: 4 hours following product administration
|
How fast does the subject feel relief of symptoms measured in time after application of the drug.
|
4 hours following product administration
|
Recurrence of symptoms
Time Frame: 4 hours following product administration
|
When do the symptoms return measured in time after application of the drug.
|
4 hours following product administration
|
Severity and frequency of adverse events
Time Frame: 14 days
|
Assessment of severity and frequency of adverse events.
|
14 days
|
Laboratory assessment
Time Frame: 14 days
|
Assessment of changes in blood chemistry, hematology and urinalysis at day 14 compared to baseline.
|
14 days
|
Electrocardiography
Time Frame: 14 days
|
Assessment of changes in ECG parameters at day 14 compared to baseline.
|
14 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Alan S. Lader, Ph.D., Citius Pharmaceuticals
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Gastrointestinal Diseases
- Intestinal Diseases
- Rectal Diseases
- Hemorrhoids
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
- Hydrocortisone
- Hydrocortisone 17-butyrate 21-propionate
- Hydrocortisone acetate
- Hydrocortisone hemisuccinate
Other Study ID Numbers
- 143-6151-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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