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
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|ClinicalTrials.gov Identifier: NCT02010099|
Recruitment Status : Completed
First Posted : December 12, 2013
Last Update Posted : June 3, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Bleeding Hemorrhoids||Drug: PP110 Gel Drug: PP110 Medicated wipes Drug: Preparation-H Cream||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||June 2014|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02010099
|Kfar Saba, Israel|
|Kiryat Ono, Israel|
|Principal Investigator:||Ehud Klein, Prof.||Maccabi Healthcare Services, Israel|