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Topical 2% Lidocaine for the Treatment of Symptomatic Hemorrhoids

NCT01961739 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2013-10-14

No results posted yet for this study

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

Conditions

Interventions

DRUG

2% lidocaine

Topical application, twice per day for 15 consecutive days

DRUG

placebo

topical application, twice per day for 15 consecutive days

Sponsors & Collaborators

  • Clinical Hospital Centre Zagreb

    collaborator OTHER

  • University Hospital Dubrava

    lead OTHER

Principal Investigators

  • Mario Kopljar, MD, PhD · University Hospital Dubrava

  • Tihomir Kekez · Clinical Hospital Centre Zagreb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Croatia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01961739 on ClinicalTrials.gov