Topical 2% Lidocaine for the Treatment of Symptomatic Hemorrhoids
NCT ID: NCT01961739
Last Updated: 2013-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
138 participants
INTERVENTIONAL
2013-10-31
2014-03-31
Brief Summary
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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
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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2% lidocaine
topical application, two times per day for 15 consecutive days
2% lidocaine
Topical application, twice per day for 15 consecutive days
placebo
vaseline base applied topically, two times per day for 15 consecutive days
placebo
topical application, twice per day for 15 consecutive days
Interventions
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2% lidocaine
Topical application, twice per day for 15 consecutive days
placebo
topical application, twice per day for 15 consecutive days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Clinical Hospital Centre Zagreb
OTHER
University Hospital Dubrava
OTHER
Responsible Party
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Mario Kopljar
Dr. sc.
Principal Investigators
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Mario Kopljar, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Dubrava
Tihomir Kekez
Role: PRINCIPAL_INVESTIGATOR
Clinical Hospital Centre Zagreb
Locations
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Clinical Hospital Centre Zagreb
Zagreb, , Croatia
Clinical Hospital Dubrava
Zagreb, , Croatia
Countries
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Central Contacts
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Facility Contacts
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Tihomir Kekez, MD
Role: primary
Mario Kopljar, MD, PhD
Role: primary
Other Identifiers
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PROTOCOL H1-5
Identifier Type: -
Identifier Source: org_study_id