Bleeding HemorrhoidsPhase 2/3NCT02010099
A Prospective, Randomized, Three Arms, Open Label Study Comparing the Safety and Efficacy of Two Formulations of PP110 to the Active Comparator Preparation-H® Cream in the Treatment of Bleeding Hemorrhoids Grades 2-3
A Phase 2/3 study testing PP110 Gel, PP110 Medicated wipes and Preparation-H Cream in people with Bleeding Hemorrhoids, run by Peritech Pharma Ltd. at 5 sites in Israel.
Trial summary
Eligible patients with bleeding hemorrhoids of grade 2-3 are randomized to test-1 product (PP110 Gel), test-2 product (PP-110 medicated wipes) or control (Preparation-H cream). Test product usage: once daily, about 1-5 minutes prior to first bowel movement. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bleeding Hemorrhoids
- What is being tested?
- PP110 Gel, PP110 Medicated wipes and Preparation-H Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 5 sitesIsrael
- Study dates
- Nov 2013to Jun 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70
- Bleeding hemorrhoids with / without pain
- Diagnosis of internal hemorrhoids of grade 2-3, or external bleeding hemorrhoids
- Signed Informed Consent
Who cannot join
- Known rectal sensitivity
- Rectal infection
- Grade IV hemorrhoids
- Use of anti-coagulants (except Aspirin or Plavix) within 30 days prior to enrollment
- Known inflammatory bowel disease
- Anal fissure
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- Military personnel
- Female patients that are pregnant, or are not using a reliable method of birth control, or are nursing
- Patients who have been involved in another experimental trial within the past 30 days
- Patients presently diagnosed with cancer
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Israel5 sites
Study site
Kfar Saba
Study site
Kiryat Ono
Study site
Modiin
Study site
Ramat Gan
Study site
Tel Aviv
About this study
Eligible patients with bleeding hemorrhoids of grade 2-3 are randomized to test-1 product (PP110 Gel), test-2 product (PP-110 medicated wipes) or control (Preparation-H cream).
Test product usage: once daily, about 1-5 minutes prior to first bowel movement. Control product usage: according to label, 3-4 times daily application to rectal region.
Read more
At the end of each day, subject fills a questionnaire regarding bleeding, pain, discharge, swelling, itching, discomfort and painkiller usage.
Treatment is for two weeks, after which subjects fill a feedback questionnaire addressing treatment efficacy and subject satisfaction. Also, at the end of two weeks, subjects are examined by study physician who assesses hemorrhoid severity.
- Conditions
- Bleeding Hemorrhoids
- Being tested
- PP110 Gel, PP110 Medicated wipes, Preparation-H Cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PP110 GelDrug
PP110 Medicated wipesDrug
Preparation-H CreamDrug
| Study group | Role | What they receive |
|---|---|---|
| PP110 Gel | Experimental | PP110 Gel Receives: Drug: PP110 Gel |
| PP110 medicated wipes | Experimental | PP110 Medicated wipes Receives: Drug: PP110 Medicated wipes |
| Preparation-H cream | Active comparator | Preparation-H cream Receives: Drug: Preparation-H Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding / Spotting
Measured: 14 days
Secondary outcomes (6)
Pain
Measured: 14 days
Discharge
Measured: 14 days
Itching
Measured: 14 days
Swelling
Measured: 14 days
Discomfort
Measured: 14 days
Painkillers usage
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bleeding 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
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peritech Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ehud Klein, Prof., Principal investigator, Maccabi Healthcare Services, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010099
- Sponsor's protocol ID
- PP110 01
- Status last verified
- Jun 2014
- First submitted
- 9 Dec 2013
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Three Arms, Open Label Study Comparing the Safety and Efficacy of Two Formulations of PP110 to the Active Comparator Preparation-H® Cream in the Treatment of Bleeding Hemorrhoids Grades 2-3
- ClinicalTrials.gov ID
- NCT02010099
- Acronym / sponsor ID
- PP110 01
- Conditions
- Bleeding Hemorrhoids
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Peritech Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 12 Dec 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.
Eligible patients with bleeding hemorrhoids of grade 2-3 are randomized to test-1 product (PP110 Gel), test-2 product (PP-110 medicated wipes) or control (Preparation-H cream).
Test product usage: once daily, about 1-5 minutes prior to first bowel movement. Control product usage: according to label, 3-4 times daily application to rectal region.
At the end of each day, subject fills a questionnaire regarding bleeding, pain, discharge, swelling, itching, discomfort and painkiller usage.
Treatment is for two weeks, after which subjects fill a feedback questionnaire addressing treatment efficacy and subject satisfaction. Also, at the end of two weeks, subjects are examined by study physician who assesses hemorrhoid severity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PP110 Gel | Experimental | Drug: PP110 GelPP110 Gel |
| PP110 medicated wipes | Experimental | Drug: PP110 Medicated wipesPP110 Medicated wipes |
| Preparation-H cream | Active comparator | Drug: Preparation-H CreamPreparation-H cream |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-70
- Bleeding hemorrhoids with / without pain
- Diagnosis of internal hemorrhoids of grade 2-3, or external bleeding hemorrhoids
- Signed Informed Consent
Key exclusion criteria (10 listed)
- Known rectal sensitivity
- Rectal infection
- Grade IV hemorrhoids
- Use of anti-coagulants (except Aspirin or Plavix) within 30 days prior to enrollment
- Known inflammatory bowel disease
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 |
|---|---|---|
| PP110 Gel | Drug | PP110 Gel |
| PP110 Medicated wipes | Drug | PP110 medicated wipes |
| Preparation-H Cream | Drug | Preparation-H cream |
Primary outcome
Bleeding / Spotting
Time frame: 14 days
6 secondary outcomes
Pain
Time frame: 14 days
Discharge
Time frame: 14 days
Itching
Time frame: 14 days
Swelling
Time frame: 14 days
Discomfort
Time frame: 14 days
Painkillers usage
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2014.
- Related InfoLink provided by the sponsor.
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Comparing Rectal Artery Embolization and Surgery for Treatment of Bleeding Grade 2 and 3 Internal Hemorrhoids
Hemorrhoids Internal, Hemorrhoids Second Degree
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Trial of Latex vs Non-latex Hemorrhoid Banding
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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.
Ehud Klein, Prof. principal investigator
Maccabi Healthcare Services, Israel
5 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 PP110 Gel, PP110 Medicated wipes and Preparation-H Cream in people with Bleeding Hemorrhoids, run by Peritech Pharma Ltd. at 5 sites in Israel.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 3 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Israel. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding / Spotting (time frame: 14 days). 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 3 Jun 2014.