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OpenTrials
Completed

NCT Number: NCT02010099

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

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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Key information

Conditions

Bleeding Hemorrhoids

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Kfar Saba, Israel

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PP110 Gel

Drug

PP110 Medicated wipes

Drug

Preparation-H Cream

Drug

Primary outcomes

  1. Bleeding / Spotting

    Time frame: 14 days

Secondary outcomes

  1. Pain

    Time frame: 14 days

  2. Discharge

    Time frame: 14 days

  3. Itching

    Time frame: 14 days

  4. Swelling

    Time frame: 14 days

  5. Discomfort

    Time frame: 14 days

  6. Painkillers usage

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Peritech Pharma Ltd.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 12, 2013
Registry last updated
Jun 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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