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
Information source: Peritech Pharma Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bleeding Hemorrhoids
Intervention: PP110 Gel (Drug); PP110 Medicated wipes (Drug); Preparation-H Cream (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Peritech Pharma Ltd. Official(s) and/or principal investigator(s):
Ehud Klein, Prof., Principal Investigator, Affiliation: Maccabi Healthcare Services, Israel
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bleeding / Spotting
Secondary outcome: PainDischarge Itching Swelling Discomfort Painkillers usage
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Kfar Saba, Israel
Kiryat Ono, Israel
Modiin, Israel
Ramat-Gan, Israel
Tel-Aviv, Israel
Additional Information
Starting date: November 2013
Last updated: June 1, 2014
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