Topical 2% Lidocaine for the Treatment of Symptomatic Hemorrhoids (H1-5)

Double Blinded Randomized Clinical Trial of the Efficacy of Topical 2% Lidocaine for the Treatment of Symptomatic Hemorrhoids

The primary objective of this study is to evaluate the efficacy of topical 2% lidocaine in the therapy of symptomatic hemorrhoids. Efficacy will be determined by:

1. the change from baseline in pain, itching, bleeding, swelling, discomfort, general well-being and improvement since the beginning of treatment as separate components of CORRECTS scale
2. the change in overall CORRECTS values from baseline
3. the change in degree of hemorrhoids from baseline

Study Overview

• Status: Unknown
• Conditions: Hemorrhoids
• Intervention / Treatment: Drug: 2% lidocaine; Drug: placebo

Detailed Description

This is a double blinded randomized clinical study into the effect of topical 2% lidocaine in patients with symptomatic hemorrhoids.

Calculated sample size is 69 patients per arm, based on expected improvement of pain and healing by 30% at p<0.05 and power goal of 95%. Taking into account a drop-out rate of 50%, total number of 69 patients in each arm is estimated as sufficient to close the study.

Patients will be randomly assigned into 2 arms, arm 1 (treatment): topical 2% lidocaine and arm 2 (control): vaseline base. Each arm will consist of 69 patients. Patients will be assigned to either treatment or control arm according to the randomization table.

• Treatment arm - topical 2% lidocaine. Topical application of 2% lidocaine in vaseline base repeated two times per day,
• Control arm - vaseline base. Topical application of pure vaseline base twice per day.

In addition to the aforementioned topical treatments, all patients will be given written instructions to perform dietary modifications and anal hygiene. All patients with bleeding hemorrhoids will be given Detralex 2 tablets twice per day.

Those patients in whom a technically successful procedure has been completed will be considered as valuable for the efficacy evaluation. A technically successful procedure is defined as the completion of treatment procedures stipulated in this protocol and consists of correct drug dose and frequency of application, adherence to written instructions for dietary modification and anal hygiene and presence at follow-up visits.

• Study Type: Interventional
• Enrollment (Anticipated): 138
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Tihomir Kekez, MD, PhD; Phone Number: +385959110879; Email: tihomirkekez@gmail.com

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • Recruiting
    • Clinical Hospital Centre Zagreb
    • Contact: Tihomir Kekez, MD
    • Principal Investigator: Tihomir Kekez, MD, MSc
  • Zagreb, Croatia, 10000
    • Recruiting
    • Clinical Hospital Dubrava
    • Contact: Mario Kopljar, MD, PhD; Phone Number: +385915827446; Email: kopljar@yahoo.com
    • Principal Investigator: Mario Kopljar, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• clinically present enlarged hemorrhoids, grade 1-4 (for definition see Appendix 1)
• symptoms of pain or itching
• age 18 years or more
• willing and able to comply with the study
• geographically suitable, meaning with reliable transportation for outpatients to the testing site

Exclusion Criteria:

• actual pregnancy
• inability to provide informed consent
• any anal topical medication applied in the last 7 days
• any anal surgery (including surgical or instrumental procedures defined in the section 4.3) in the last 60 days
• known allergy to vaseline, lidocaine or Dulcolax
• other anal disorders and diseases including Crohns disease, ulcerative colitis, undefined inflammatory bowel disease, anal fissures, perianal fistulas, perianal rash or eczema, rectal prolapse, rectocele, benign or malignant anal and rectal tumor and perianal infections
• contraindication for topical anal application of vaseline or lidocaine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2% lidocaine; topical application, two times per day for 15 consecutive days	Drug: 2% lidocaine; Topical application, twice per day for 15 consecutive days; Other Names: lidocaine
Placebo Comparator: placebo; vaseline base applied topically, two times per day for 15 consecutive days	Drug: placebo; topical application, twice per day for 15 consecutive days; Other Names: vaseline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in CORRECTS scale	Change in CORRECTS scale and grade of haemorrhoids	15 days after treatment initiantion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of adverse events	Secondary objective is to assess the safety and tolerability of [TREATMENT] by determining: percentage of adverse events (complications); percentage of treatment discontinuations due to adverse events	within 15 days after treatment initiation

Collaborators and Investigators

• Sponsor: University Hospital Dubrava
• Collaborators: Clinical Hospital Centre Zagreb
• Investigators: Principal Investigator: Mario Kopljar, MD, PhD, University Hospital Dubrava; Principal Investigator: Tihomir Kekez, Clinical Hospital Centre Zagreb

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): March 1, 2014
• Study Completion (Anticipated): March 1, 2014

Study Registration Dates

• First Submitted: October 9, 2013
• First Submitted That Met QC Criteria: October 9, 2013
• First Posted (Estimate): October 11, 2013

Study Record Updates

• Last Update Posted (Estimate): October 14, 2013
• Last Update Submitted That Met QC Criteria: October 10, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Lidocaine; Hemorrhoids
• 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; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: PROTOCOL H1-5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No