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

• Sponsor: Peritech Pharma Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02010099
• Collaborator: (none)
• Enrollment: 101
• Locations: 5
• Arms: 3
• Duration (Months): 7
• Patients Per Site: 20.2
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 101 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Bleeding / Spotting [14 days]

Secondary Outcome Measures

1. Pain [14 days]

2. Discharge [14 days]

3. Itching [14 days]

4. Swelling [14 days]

5. Discomfort [14 days]

6. Painkillers usage [14 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Kfar Saba		Israel
2		Kiryat Ono		Israel
3		Modiin		Israel
4		Ramat-Gan		Israel
5		Tel-Aviv		Israel

Sponsors and Collaborators

• Peritech Pharma Ltd.

Investigators

• Principal Investigator: Ehud Klein, Prof., Maccabi Healthcare Services, Israel

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Peritech Pharma Ltd.
• ClinicalTrials.gov Identifier: NCT02010099
• Other Study ID Numbers: PP110 01
• First Posted: Dec 12, 2013
• Last Update Posted: Jun 3, 2014
• Last Verified: Jun 1, 2014

• Additional relevant MeSH terms: Hemorrhoids; Hemorrhage

Study Results

No Results Posted as of Jun 3, 2014