HemorrhoidsPhase 2/3H1-5NCT01961739
Topical 2% Lidocaine for the Treatment of Symptomatic Hemorrhoids
A Phase 2/3 study testing 2% lidocaine in people with Hemorrhoids, run by University Hospital Dubrava at 2 sites in Croatia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- 2% lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 2 sitesCroatia
- Study dates
- Oct 2013to Mar 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Croatia2 sites, 2 recruiting
- Recruiting
Clinical Hospital Centre Zagreb
Zagreb, 10000
Tihomir Kekez, MD
Tihomir Kekez, MD, MSc
- Recruiting
Clinical Hospital Dubrava
Zagreb, 10000
Mario Kopljar, MD, PhD, +385915827446, kopljar@yahoo.com
Mario Kopljar, MD, PhD
About this study
Official title: Double Blinded Randomized Clinical Trial of the Efficacy of Topical 2% Lidocaine for the Treatment of Symptomatic Hemorrhoids
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
Read the detailed 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.
- Conditions
- Hemorrhoids
- Being tested
- 2% lidocaine, placebo
- Keywords
- Hemorrhoids, Lidocaine
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% lidocaineDrug
Also called lidocaine
Topical application, twice per day for 15 consecutive days
placeboDrug
Also called vaseline
topical application, twice per day for 15 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| 2% lidocaine | Experimental | topical application, two times per day for 15 consecutive days Receives: Drug: 2% lidocaine |
| placebo | Placebo comparator | vaseline base applied topically, two times per day for 15 consecutive days Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CORRECTS scale
Change in CORRECTS scale and grade of haemorrhoids
Measured: 15 days after treatment initiantion
Secondary outcomes (1)
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
Measured: within 15 days after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Dubrava
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Hospital Centre Zagreb
- Responsible party
- Principal investigator, Mario Kopljar, University Hospital Dubrava
- Investigators
- Mario Kopljar, MD, PhD, Principal investigator, University Hospital DubravaTihomir Kekez, Principal investigator, Clinical Hospital Centre Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961739
- Sponsor's protocol ID
- PROTOCOL H1-5
- Acronym
- H1-5
- Status last verified
- Oct 2013
- First submitted
- 9 Oct 2013
- Last updated
- 14 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded Randomized Clinical Trial of the Efficacy of Topical 2% Lidocaine for the Treatment of Symptomatic Hemorrhoids
- ClinicalTrials.gov ID
- NCT01961739
- Acronym / sponsor ID
- H1-5 / PROTOCOL H1-5
- Conditions
- Hemorrhoids
- Keywords
- Hemorrhoids, Lidocaine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- University Hospital DubravaUniversity, hospital or other
- Collaborators
- Clinical Hospital Centre Zagreb
- Study start
- Oct 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 11 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2% lidocaine | Experimental | Drug: 2% lidocainetopical application, two times per day for 15 consecutive days |
| placebo | Placebo comparator | Drug: placebovaseline base applied topically, two times per day for 15 consecutive days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2% lidocaineAlso: lidocaineTopical application, twice per day for 15 consecutive days | Drug | 2% lidocaine |
| placeboAlso: vaselinetopical application, twice per day for 15 consecutive days | Drug | placebo |
Primary outcome
Change in CORRECTS scale
Time frame: 15 days after treatment initiantion
Change in CORRECTS scale and grade of haemorrhoids
1 secondary outcome
Percentage of adverse events
Time frame: within 15 days after treatment initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Kopljar, MD, PhD principal investigator
University Hospital Dubrava
Tihomir Kekez principal investigator
Clinical Hospital Centre Zagreb
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 2% lidocaine in people with Hemorrhoids, run by University Hospital Dubrava at 2 sites in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tihomir Kekez, MD, PhD (+385959110879, tihomirkekez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CORRECTS scale (time frame: 15 days after treatment initiantion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2013.