Topical 2% Lidocaine for the Treatment of Symptomatic Hemorrhoids (H1-5)
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:
- 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
- the change in overall CORRECTS values from baseline
- the change in degree of hemorrhoids from baseline
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Double Blinded Randomized Clinical Trial of the Efficacy of Topical 2% Lidocaine for the Treatment of Symptomatic Hemorrhoids|
- Change in CORRECTS scale [ Time Frame: 15 days after treatment initiantion ] [ Designated as safety issue: Yes ]Change in CORRECTS scale and grade of haemorrhoids
- Percentage of adverse events [ Time Frame: within 15 days after treatment initiation ] [ Designated as safety issue: Yes ]
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
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: 2% lidocaine
topical application, two times per day for 15 consecutive days
Drug: 2% lidocaine
Topical application, twice per day for 15 consecutive days
Other Name: lidocaine
Placebo Comparator: placebo
vaseline base applied topically, two times per day for 15 consecutive days
topical application, twice per day for 15 consecutive days
Other Name: vaseline
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.
|Contact: Tihomir Kekez, MD, PhDemail@example.com|
|Clinical Hospital Dubrava||Recruiting|
|Zagreb, Croatia, 10000|
|Contact: Mario Kopljar, MD, PhD +385915827446 firstname.lastname@example.org|
|Principal Investigator: Mario Kopljar, MD, PhD|
|Clinical Hospital Centre Zagreb||Recruiting|
|Zagreb, Croatia, 10000|
|Contact: Tihomir Kekez, MD|
|Principal Investigator: Tihomir Kekez, MD, MSc|
|Principal Investigator:||Mario Kopljar, MD, PhD||University Hospital Dubrava|
|Principal Investigator:||Tihomir Kekez||Clinical Hospital Centre Zagreb|