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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01961739
Recruitment Status : Unknown
Verified October 2013 by Mario Kopljar, University Hospital Dubrava.
Recruitment status was:  Recruiting
First Posted : October 11, 2013
Last Update Posted : October 14, 2013
Clinical Hospital Centre Zagreb
Information provided by (Responsible Party):
Mario Kopljar, University Hospital Dubrava

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Hemorrhoids Drug: 2% lidocaine Drug: placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Blinded Randomized Clinical Trial of the Efficacy of Topical 2% Lidocaine for the Treatment of Symptomatic Hemorrhoids
Study Start Date : October 2013
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

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 Name: 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 Name: vaseline

Primary Outcome Measures :
  1. Change in CORRECTS scale [ Time Frame: 15 days after treatment initiantion ]
    Change in CORRECTS scale and grade of haemorrhoids

Secondary Outcome Measures :
  1. Percentage of adverse events [ Time Frame: within 15 days after treatment initiation ]

    Secondary objective is to assess the safety and tolerability of [TREATMENT] by determining:

    1. percentage of adverse events (complications)
    2. percentage of treatment discontinuations due to adverse events

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01961739

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Contact: Tihomir Kekez, MD, PhD +385959110879

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Clinical Hospital Centre Zagreb Recruiting
Zagreb, Croatia, 10000
Contact: Tihomir Kekez, MD         
Principal Investigator: Tihomir Kekez, MD, MSc         
Clinical Hospital Dubrava Recruiting
Zagreb, Croatia, 10000
Contact: Mario Kopljar, MD, PhD    +385915827446   
Principal Investigator: Mario Kopljar, MD, PhD         
Sponsors and Collaborators
University Hospital Dubrava
Clinical Hospital Centre Zagreb
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Principal Investigator: Mario Kopljar, MD, PhD University Hospital Dubrava
Principal Investigator: Tihomir Kekez Clinical Hospital Centre Zagreb
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Responsible Party: Mario Kopljar, Dr. sc., University Hospital Dubrava Identifier: NCT01961739    
Other Study ID Numbers: PROTOCOL H1-5
First Posted: October 11, 2013    Key Record Dates
Last Update Posted: October 14, 2013
Last Verified: October 2013
Keywords provided by Mario Kopljar, University Hospital Dubrava:
Additional relevant MeSH terms:
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Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Anesthetics, Local
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