Topical 2% Lidocaine for the Treatment of Symptomatic Hemorrhoids

Hemorrhoids Clinical Trial

— H1-5  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01961739
• Other study ID #: PROTOCOL H1-5
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: October 9, 2013
• Last updated: October 10, 2013
• Start date: October 2013
• Est. completion date: March 2014

Study information

• Verified date: October 2013
• Source: University Hospital Dubrava
• Contact: Tihomir Kekez, MD, PhD
• Phone: +385959110879
• Email: tihomirkekez[@]gmail.com
• Is FDA regulated: No
• Health authority: Croatia: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

Drug:
• 2% lidocaine
Topical application, twice per day for 15 consecutive days
• placebo
topical application, twice per day for 15 consecutive days

Locations

Country	Name	City	State
Croatia	Clinical Hospital Centre Zagreb	Zagreb
Croatia	Clinical Hospital Dubrava	Zagreb

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Dubrava	Clinical Hospital Centre Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CORRECTS scale	Change in CORRECTS scale and grade of haemorrhoids	15 days after treatment initiantion	Yes
Secondary	Percentage of adverse events	Secondary objective is to assess the safety and tolerability of [TREATMENT] by determining: percentage of adverse events (complications); percentage of treatment discontinuations due to adverse events	within 15 days after treatment initiation	Yes