Topical 2% Lidocaine for the Treatment of Symptomatic Hemorrhoids (H1-5)
|ClinicalTrials.gov Identifier: NCT01961739|
Recruitment Status : Unknown
Verified October 2013 by Mario Kopljar, University Hospital Dubrava.
Recruitment status was: Recruiting
First Posted : October 11, 2013
Last Update Posted : October 14, 2013
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
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhoids||Drug: 2% lidocaine Drug: placebo||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||138 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Double Blinded Randomized Clinical Trial of the Efficacy of Topical 2% Lidocaine for the Treatment of Symptomatic Hemorrhoids|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||March 2014|
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
- Change in CORRECTS scale [ Time Frame: 15 days after treatment initiantion ]Change in CORRECTS scale and grade of haemorrhoids
- Percentage of adverse events [ Time Frame: within 15 days after treatment initiation ]
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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01961739
|Contact: Tihomir Kekez, MD, PhDfirstname.lastname@example.org|
|Clinical Hospital Centre Zagreb||Recruiting|
|Zagreb, Croatia, 10000|
|Contact: Tihomir Kekez, MD|
|Principal Investigator: Tihomir Kekez, MD, MSc|
|Clinical Hospital Dubrava||Recruiting|
|Zagreb, Croatia, 10000|
|Contact: Mario Kopljar, MD, PhD +385915827446 email@example.com|
|Principal Investigator: Mario Kopljar, MD, PhD|
|Principal Investigator:||Mario Kopljar, MD, PhD||University Hospital Dubrava|
|Principal Investigator:||Tihomir Kekez||Clinical Hospital Centre Zagreb|