Topical 2% Lidocaine for the Treatment of Symptomatic Hemorrhoids

• Status: Unknown status
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Dubrava
• Collaborator: Clinical Hospital Centre Zagreb
• Treatments: Lidocaine; Petrolatum

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