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

Peritech Pharma

Status and phase: Completed; Phase 3; Phase 2

Conditions: Bleeding Hemorrhoids

Treatments: Drug: PP110 Gel; Drug: Preparation-H Cream; Drug: PP110 Medicated wipes

Study type: Interventional

Funder types: Industry

Identifiers

NCT02010099

PP110 01

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Known rectal sensitivity
2. Rectal infection
3. Grade IV hemorrhoids
4. Use of anti-coagulants (except Aspirin or Plavix) within 30 days prior to enrollment
5. Known inflammatory bowel disease
6. Anal fissure
7. Military personnel
8. Female patients that are pregnant, or are not using a reliable method of birth control, or are nursing
9. Patients who have been involved in another experimental trial within the past 30 days
10. Patients presently diagnosed with cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 3 patient groups

PP110 Gel

Experimental group

Description:

PP110 Gel

Treatment:

Drug: PP110 Gel

PP110 medicated wipes

Experimental group

Description:

PP110 Medicated wipes

Treatment:

Drug: PP110 Medicated wipes

Preparation-H cream

Active Comparator group

Description:

Preparation-H cream

Treatment:

Drug: Preparation-H Cream