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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peritech Pharma Ltd.
ClinicalTrials.gov Identifier:
NCT02010099
First received: December 9, 2013
Last updated: June 1, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Bleeding Hemorrhoids
Drug: PP110 Gel
Drug: PP110 Medicated wipes
Drug: Preparation-H Cream
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Peritech Pharma Ltd.:

Primary Outcome Measures:
  • Bleeding / Spotting [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pain [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Discharge [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Itching [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Swelling [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Discomfort [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Painkillers usage [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: November 2013
Study Completion Date: June 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02010099

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

Additional Information:
No publications provided

Responsible Party: Peritech Pharma Ltd.
ClinicalTrials.gov Identifier: NCT02010099     History of Changes
Other Study ID Numbers: PP110 01
Study First Received: December 9, 2013
Last Updated: June 1, 2014
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Hemorrhage
Hemorrhoids
Pathologic Processes
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Glycerol
Phenylephrine
Petrolatum
Pramoxine
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Emollients
Dermatologic Agents
Therapeutic Uses
Cardiotonic Agents
Cardiovascular Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists

ClinicalTrials.gov processed this record on August 18, 2014