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
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.
|Bleeding Hemorrhoids||Drug: PP110 Gel Drug: PP110 Medicated wipes Drug: Preparation-H Cream||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
- Bleeding / Spotting [ Time Frame: 14 days ]
- 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 ]
|Study Start Date:||November 2013|
|Study Completion Date:||June 2014|
|Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Experimental: PP110 Gel
|Drug: PP110 Gel|
Experimental: PP110 medicated wipes
PP110 Medicated wipes
|Drug: PP110 Medicated wipes|
Active Comparator: Preparation-H cream
|Drug: Preparation-H Cream|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02010099
|Kfar Saba, Israel|
|Kiryat Ono, Israel|
|Principal Investigator:||Ehud Klein, Prof.||Maccabi Healthcare Services, Israel|