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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Bleeding Hemorrhoids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PP110 Gel

Group Type EXPERIMENTAL

PP110 Gel

Intervention Type DRUG

PP110 medicated wipes

PP110 Medicated wipes

Group Type EXPERIMENTAL

PP110 Medicated wipes

Intervention Type DRUG

Preparation-H cream

Group Type ACTIVE_COMPARATOR

Preparation-H Cream

Intervention Type DRUG

Interventions

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PP110 Gel

Intervention Type DRUG

PP110 Medicated wipes

Intervention Type DRUG

Preparation-H Cream

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No