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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University Hospital Dubrava
Sponsor:
Collaborator:
Clinical Hospital Centre Zagreb
Information provided by (Responsible Party):
Mario Kopljar, University Hospital Dubrava
ClinicalTrials.gov Identifier:
NCT01961739
First received: October 9, 2013
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Hemorrhoids
Drug: 2% lidocaine
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University Hospital Dubrava:

Primary Outcome Measures:
  • Change in CORRECTS scale [ Time Frame: 15 days after treatment initiantion ] [ Designated as safety issue: Yes ]
    Change in CORRECTS scale and grade of haemorrhoids


Secondary Outcome Measures:
  • Percentage of adverse events [ Time Frame: within 15 days after treatment initiation ] [ Designated as safety issue: Yes ]

    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


Estimated Enrollment: 138
Study Start Date: October 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01961739

Contacts
Contact: Tihomir Kekez, MD, PhD +385959110879 tihomirkekez@gmail.com

Locations
Croatia
Clinical Hospital Dubrava Recruiting
Zagreb, Croatia, 10000
Contact: Mario Kopljar, MD, PhD    +385915827446    kopljar@yahoo.com   
Principal Investigator: Mario Kopljar, MD, PhD         
Clinical Hospital Centre Zagreb Recruiting
Zagreb, Croatia, 10000
Contact: Tihomir Kekez, MD         
Principal Investigator: Tihomir Kekez, MD, MSc         
Sponsors and Collaborators
University Hospital Dubrava
Clinical Hospital Centre Zagreb
Investigators
Principal Investigator: Mario Kopljar, MD, PhD University Hospital Dubrava
Principal Investigator: Tihomir Kekez Clinical Hospital Centre Zagreb
  More Information

No publications provided

Responsible Party: Mario Kopljar, Dr. sc., University Hospital Dubrava
ClinicalTrials.gov Identifier: NCT01961739     History of Changes
Other Study ID Numbers: PROTOCOL H1-5
Study First Received: October 9, 2013
Last Updated: October 10, 2013
Health Authority: Croatia: Ethics Committee

Keywords provided by University Hospital Dubrava:
Hemorrhoids
Lidocaine

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Lidocaine
Petrolatum
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Emollients
Dermatologic Agents

ClinicalTrials.gov processed this record on July 24, 2014