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Safety and Efficacy of Hydrocortisone and Lidocaine Treatment of Grade I and II Hemorrhoids (Hydro/Lido)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Citius Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02689856
First received: February 17, 2016
Last updated: February 23, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention Phase
Hemorrhoids
Drug: Hydrocortisone acetate and lidocaine hydrochloride
Drug: Placebo control
Drug: Hydrocortisone acetate
Drug: Lidocaine hydrochloride
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Citius Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Global score of disease severity [ Time Frame: up to 14 days ]
    A measure overall discomfort on a scale of 0 to 5


Secondary Outcome Measures:
  • 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.

  • 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.

  • Recurrence of symptoms [ Time Frame: 4 hours following product administration ]
    When do the symptoms return measured in time after application of the drug.

  • Severity and frequency of adverse events [ Time Frame: 14 days ]
    Assessment of severity and frequency of adverse events.

  • Laboratory assessment [ Time Frame: 14 days ]
    Assessment of changes in blood chemistry, hematology and urinalysis at day 14 compared to baseline.

  • Electrocardiography [ Time Frame: 14 days ]
    Assessment of changes in ECG parameters at day 14 compared to baseline.


Enrollment: 211
Study Start Date: May 2015
Study Completion Date: October 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Vehicle cream
Placebo control base cream
Drug: Placebo control
Vehicle cream alone
Experimental: 3% hydrocortisone
3% Hydrocortisone acetate cream
Drug: Hydrocortisone acetate
hydrocortisone alone
Experimental: 0.5% hydrocortisone
0.5% Hydrocortisone acetate cream
Drug: Hydrocortisone acetate
hydrocortisone alone
Experimental: 5% lidocaine
5% Lidocaine hydrochloride cream
Drug: Lidocaine hydrochloride
lidocaine alone
Experimental: 1% lidocaine
1% Lidocaine hydrochloride cream
Drug: Lidocaine hydrochloride
lidocaine alone
Experimental: 3% Hydro 5% Lido
Hydrocortisone acetate and lidocaine hydrochloride at 3% and 5% cream
Drug: Hydrocortisone acetate and lidocaine hydrochloride
Hydrocortisone and lidocaine in combination
Experimental: 0.5% Hydro 1% Lido
Hydrocortisone acetate and lidocaine hydrochloride at 0.5% and 1% cream
Drug: Hydrocortisone acetate and lidocaine hydrochloride
Hydrocortisone and lidocaine in combination

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):

  1. Vehicle Cream
  2. 3% Hydrocortisone Acetate Cream
  3. 0.5% Hydrocortisone Acetate Cream
  4. 5% Lidocaine Hydrochloride Cream
  5. 1% Lidocaine Hydrochloride Cream
  6. 3% Hydrocortisone Acetate Cream and 5% Lidocaine Hydrochloride Cream
  7. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Subject has provided written and verbal informed consent.
  3. Subject presents to the clinic with clinically confirmed symptomatic Grade I or II hemorrhoids (GSDS ≥ 2).
  4. Subject is willing and able to comply with study instructions and return to the clinic for required visits.

Exclusion Criteria:

  1. Subject is female and lactating or planning to become pregnant during the study.
  2. 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.
  3. Subject has a history of previous proctological surgery or has active inflammatory bowel disease.
  4. Subject may use stool softeners, but shall be on a stable regimen for at least 28 days prior to enrolling in the study.
  5. 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.
  6. Subject has a current history of an uncorrected coagulation defect or concurrently uses anticoagulants (except aspirin or non-steroidals).
  7. 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.
  8. Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles.
  9. 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.
  10. Subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, impaired cerebral function or physical limitations.
  11. 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.
  12. Subject is currently enrolled in an investigational drug or device study.
  13. Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (Baseline).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02689856

Sponsors and Collaborators
Citius Pharmaceuticals, Inc.
Investigators
Study Director: Alan S. Lader, Ph.D. Citius Pharmaceuticals
  More Information

Responsible Party: Citius Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02689856     History of Changes
Other Study ID Numbers: 143-6151-201
Study First Received: February 17, 2016
Last Updated: February 23, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Lidocaine
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 27, 2017