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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

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ClinicalTrials.gov Identifier: NCT02010099
Recruitment Status : Completed
First Posted : December 12, 2013
Last Update Posted : June 3, 2014
Information provided by (Responsible Party):
Peritech Pharma Ltd.

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.

Condition or disease Intervention/treatment Phase
Bleeding Hemorrhoids Drug: PP110 Gel Drug: PP110 Medicated wipes Drug: Preparation-H Cream Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2013
Primary Completion Date : May 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Hemorrhoids
U.S. FDA Resources

Arm Intervention/treatment
Experimental: PP110 Gel
PP110 Gel
Drug: PP110 Gel
Experimental: PP110 medicated wipes
PP110 Medicated wipes
Drug: PP110 Medicated wipes
Active Comparator: Preparation-H cream
Preparation-H cream
Drug: Preparation-H Cream

Primary Outcome Measures :
  1. Bleeding / Spotting [ Time Frame: 14 days ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02010099

Kfar Saba, Israel
Kiryat Ono, Israel
Modiin, Israel
Ramat-Gan, Israel
Tel-Aviv, Israel
Sponsors and Collaborators
Peritech Pharma Ltd.
Principal Investigator: Ehud Klein, Prof. Maccabi Healthcare Services, Israel

Additional Information:
Responsible Party: Peritech Pharma Ltd.
ClinicalTrials.gov Identifier: NCT02010099     History of Changes
Other Study ID Numbers: PP110 01
First Posted: December 12, 2013    Key Record Dates
Last Update Posted: June 3, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Pathologic Processes
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Dermatologic Agents
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents