Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PP110 Gel | Experimental | PP110 Gel |
|
| PP110 medicated wipes | Experimental | PP110 Medicated wipes |
|
| Preparation-H cream | Active Comparator | Preparation-H cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PP110 Gel | Drug |
| ||
| PP110 Medicated wipes |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding / Spotting | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | 14 days | |
| Discharge | 14 days | |
| Itching |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ehud Klein, Prof. | Maccabi Healthcare Services, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kfar Saba | Israel | |||||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Preparation-H Cream | Drug |
|
| 14 days |
| Swelling | 14 days |
| Discomfort | 14 days |
| Painkillers usage | 14 days |
| Kiryat Ono |
| Israel |
| Modiin | Israel |
| Ramat Gan | Israel |
| Tel Aviv | Israel |