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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02010099

Enrollment

101

Registered

2013-12-12

Start date

2013-11-30

Completion date

2014-06-30

Last updated

2014-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding Hemorrhoids

Brief summary

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.

Interventions

DRUGPP110 Gel

DRUGPP110 Medicated wipes

DRUGPreparation-H Cream

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Bleeding / Spotting	14 days

Secondary

Measure	Time frame
Discomfort	14 days
Painkillers usage	14 days
Swelling	14 days
Itching	14 days
Pain	14 days
Discharge	14 days

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026