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NCT02010099 Clinical Trial

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

Bleeding Hemorrhoids Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02010099
Other study ID # PP110 01
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received December 9, 2013
Last updated June 1, 2014
Start date November 2013
Est. completion date June 2014

Study information
Verified date June 2014
Source Peritech Pharma Ltd.
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 101
Est. completion date June 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• PP110 Gel

• PP110 Medicated wipes

• Preparation-H Cream

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Peritech Pharma Ltd.

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bleeding / Spotting 14 days Yes
Secondary Pain 14 days No
Secondary Discharge 14 days No
Secondary Itching 14 days No
Secondary Swelling 14 days No
Secondary Discomfort 14 days No
Secondary Painkillers usage 14 days No

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