NCT01961739

Topical 2% Lidocaine for the Treatment of Symptomatic Hemorrhoids

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: University Hospital Dubrava · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Hemorrhoids

Interventions

Type	Name	Description
DRUG	2% lidocaine	Topical application, twice per day for 15 consecutive days
DRUG	placebo	topical application, twice per day for 15 consecutive days

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2013-10-11
• Last updated: 2013-10-14

Locations

2 sites across 1 country: Croatia