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

June 1, 2014 updated by: Peritech Pharma Ltd.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar Saba, Israel
      • Kiryat Ono, Israel
      • Modiin, Israel
      • Ramat-Gan, Israel
      • Tel-Aviv, Israel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bleeding / Spotting
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain
Time Frame: 14 days
14 days
Discharge
Time Frame: 14 days
14 days
Itching
Time Frame: 14 days
14 days
Swelling
Time Frame: 14 days
14 days
Discomfort
Time Frame: 14 days
14 days
Painkillers usage
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peritech Pharma Ltd.

Investigators

  • Principal Investigator: Ehud Klein, Prof., Maccabi Healthcare Services, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

December 9, 2013

First Submitted That Met QC Criteria

December 9, 2013

First Posted (Estimate)

December 12, 2013

Study Record Updates

Last Update Posted (Estimate)

June 3, 2014

Last Update Submitted That Met QC Criteria

June 1, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PP110 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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