Trial | NCT02010099  Report issue

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    101
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 Started
Nov 30
2013
Primary Completion
May 31
2014
Study Completion
Jun 30
2014
Last Update
Jun 03
2014
Estimate

Drug PP110 Gel

Drug PP110 Medicated wipes

Drug Preparation-H Cream

PP110 Gel Experimental

PP110 Gel

PP110 medicated wipes Experimental

PP110 Medicated wipes

Preparation-H cream Active Comparator

Preparation-H cream

Criteria 

Inclusion Criteria:

Age 18-70
Bleeding hemorrhoids with / without pain
Diagnosis of internal hemorrhoids of grade 2-3, or external bleeding hemorrhoids
Signed Informed Consent

Exclusion Criteria:

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
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
No Results Posted