Bleeding Hemorrhoids Clinical Trial
Verified date | June 2014 |
Source | Peritech Pharma Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Peritech Pharma Ltd. |
Israel,
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 |