Topical 2% Lidocaine for the Treatment of Symptomatic Hemorrhoids

NCT01961739 | Unknown Phase 2 DMC

• 1 other identifier: PROTOCOL H1-5
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 2

Brief 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. 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. 2.the change in overall CORRECTS values from baseline
3. 3.the change in degree of hemorrhoids from baseline

Conditions

Hemorrhoids

Keywords

Hemorrhoids; Lidocaine

Outcome Measures

Primary Outcomes (1)

• Change in CORRECTS scale

  Change in CORRECTS scale and grade of haemorrhoids

  15 days after treatment initiantion

Secondary Outcomes (1)

• Percentage of adverse events

  within 15 days after treatment initiation

Study Arms (2)

2% lidocaine

EXPERIMENTAL

topical application, two times per day for 15 consecutive days

Drug: 2% lidocaine

placebo

PLACEBO COMPARATOR

vaseline base applied topically, two times per day for 15 consecutive days

Drug: placebo

Interventions

2% lidocaine DRUG

Topical application, twice per day for 15 consecutive days

Also known as: lidocaine

2% lidocaine

placebo DRUG

topical application, twice per day for 15 consecutive days

Also known as: vaseline

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Dubrava: lead
• Clinical Hospital Centre Zagreb: collaborator

Study Sites (2)

Clinical Hospital Centre Zagreb

Zagreb, 10000, Croatia

RECRUITING

Clinical Hospital Dubrava

Zagreb, 10000, Croatia

RECRUITING

MeSH Terms

Conditions

Hemorrhoids

Interventions

Lidocaine; Petrolatum

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hydrocarbons

Study Officials

• Mario Kopljar, MD, PhD

  University Hospital Dubrava

  PRINCIPAL INVESTIGATOR

• Tihomir Kekez

  Clinical Hospital Centre Zagreb

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tihomir Kekez, MD, PhD

CONTACT

+385959110879; tihomirkekez@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. sc.

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 11, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: October 14, 2013

Record last verified: 2013-10

Locations

CR (2)