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
1 other identifier
interventional
101
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2013
Shorter than P25 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 9, 2013
CompletedFirst Posted
Study publicly available on registry
December 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJune 3, 2014
June 1, 2014
6 months
December 9, 2013
June 1, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Bleeding / Spotting
14 days
Secondary Outcomes (6)
Pain
14 days
Discharge
14 days
Itching
14 days
Swelling
14 days
Discomfort
14 days
- +1 more secondary outcomes
Study Arms (3)
PP110 Gel
EXPERIMENTALPP110 Gel
PP110 medicated wipes
EXPERIMENTALPP110 Medicated wipes
Preparation-H cream
ACTIVE COMPARATORPreparation-H cream
Interventions
Eligibility Criteria
You may qualify if:
- Age 18-70
- Bleeding hemorrhoids with / without pain
- Diagnosis of internal hemorrhoids of grade 2-3, or external bleeding hemorrhoids
- Signed Informed Consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Unknown Facility
Kfar Saba, Israel
Unknown Facility
Kiryat Ono, Israel
Unknown Facility
Modiin, Israel
Unknown Facility
Ramat Gan, Israel
Unknown Facility
Tel Aviv, Israel
Study Officials
- PRINCIPAL INVESTIGATOR
Ehud Klein, Prof.
Maccabi Healthcare Services, Israel
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2013
First Posted
December 12, 2013
Study Start
November 1, 2013
Primary Completion
May 1, 2014
Study Completion
June 1, 2014
Last Updated
June 3, 2014
Record last verified: 2014-06