Ignite Creation Date:
2024-05-06 @ 2:18 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02010099
Status:
COMPLETED
Last Update Posted:
2014-06-03
First Post:
2013-12-09
Brief Title:
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
Organization:
Peritech Pharma Ltd
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None